Botox Disclaimer

Please see below for the full Indications and Important Safety Information, including Boxed Warning, for BOTOX® (onabotulinumtoxinA), BOTOX® Cosmetic (onabotulinumtoxinA), and NATRELLE®, and full Indications and Important Safety Information for ALLODERM SELECT™ Regenerative Tissue Matrix, ARTIA™ RECONSTRUCTIVE TISSUE MATRIX , CoolSculpting® and CoolSculpting® Elite , CoolTone®, DALVANCE® (dalbavancin) 500 mg injection, DiamondGlow®, DURYSTA® (bimatoprost intracameral implant), JUVÉDERM® Collection of Fillers, KYBELLA® (deoxycholic acid) injection 10 mg/mL, LATISSE® (bimatoprost ophthalmic solution) 0.03%, LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg, OZURDEX® (dexamethasone intravitreal implant), REVOLVE™ Advanced Adipose System, SkinMedica®, SKINVIVE by JUVÉDERM®, STRATTICE™ BPS Reconstructive Tissue Matrix, STRATTICE™ Reconstructive Tissue Matrix, and TEFLARO® (ceftaroline fosamil) for injection

BOTOX® (onabotulinumtoxinA) & BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

• Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
• Moderate to severe lateral canthal lines associated with orbicularis oculi activity
• Moderate to severe forehead lines associated with frontalis activity
• Moderate to severe platysma bands associated with platysma muscle activity

Adult Bladder Dysfunction:
Overactive Bladder
BOTOX® for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Detrusor Overactivity Associated with a Neurologic Condition
BOTOX® is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., SCI, MS) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Pediatric Detrusor Overactivity Associated with a Neurologic Condition
BOTOX® is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication.

Chronic Migraine
BOTOX® is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).

Limitations of Use
Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in 7 placebo-controlled studies.

Spasticity
BOTOX® is indicated for the treatment of spasticity in patients 2 years of age and older.

Limitations of Use
BOTOX® has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.

Cervical Dystonia
BOTOX® is indicated for the treatment of adults with Cervical Dystonia to reduce the severity of abnormal head position and neck pain associated with Cervical Dystonia.

Blepharospasm and Strabismus
BOTOX® is indicated for the treatment of Strabismus and Blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older.

Primary Axillary Hyperhidrosis
BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents.

Limitations of Use
The safety and effectiveness of BOTOX® for hyperhidrosis in other body areas have not been established. Weakness of hand muscles and blepharoptosis may occur in patients who receive BOTOX for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.

Safety and effectiveness of BOTOX® have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

BOTOX® and BOTOX® Cosmetic are contraindicated in the presence of infection at the proposed injection site(s) and in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation.

BOTOX® is contraindicated for intradetrusor injection in patients with a urinary tract infection (UTI), or in patients with urinary retention or post-void residual (PVR) urine volume >200 mL who are not routinely performing clean intermittent self-catheterization (CIC).

WARNINGS AND PRECAUTIONS
Spread of Toxin Effect
See Boxed Warning.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm at the recommended dose (30 Units and below), severe primary axillary hyperhidrosis at the recommended dose (100 Units), strabismus, or for chronic migraine at the labeled doses have been reported.

Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX® and BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of BOTOX® and BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Serious Adverse Reactions with Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX ® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had preexisting dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, discontinue further injection of BOTOX® or BOTOX® Cosmetic and immediately institute appropriate medical therapy. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System
There have been reports following administration of BOTOX® Cosmetic of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including preexisting cardiovascular disease. Use caution when administering to patients with preexisting cardiovascular disease.

Increased Risk of Clinically Significant Effects with Preexisting Neuromuscular Disorders
Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions). Monitor individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) when given botulinum toxin.

Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with preexisting swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Preexisting Conditions at the Injection Site
Use caution when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Pulmonary Effects of BOTOX® in Patients with Compromised Respiratory Status Treated for Spasticity or for Detrusor Overactivity Associated with a Neurologic Condition
Patients with compromised respiratory status treated with BOTOX® for spasticity or detrusor overactivity associated with a neurologic condition should be monitored closely.

Corneal Exposure and Ulceration in Patients Treated With BOTOX® for Blepharospasm
Reduced blinking from BOTOX® or BOTOX® Cosmetic injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration, especially in patients with VII nerve disorders.

Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

Retrobulbar Hemorrhages in Patients Treated With BOTOX® for Strabismus
During the administration of BOTOX® for the treatment of Strabismus, retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred. It is recommended that appropriate instruments to decompress the orbit be accessible.

Spatial Disorientation, Double Vision, or Past-Pointing in Patients Treated for Strabismus
Inducing paralysis in one or more extraocular muscles may produce spatial disorientation, double vision, or past-pointing. Covering the affected eye may alleviate these symptoms.

Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
Bronchitis was reported more frequently as an adverse reaction in adult patients treated for upper limb spasticity with BOTOX® (3% at 251 Units to 360 Units total dose) compared to placebo (1%). In adult patients with reduced lung function treated for upper limb spasticity, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%). In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX® (2% at 300 Units to 400 Units total dose) compared to placebo (1%). In pediatric patients treated for upper limb spasticity, upper respiratory tract infections were reported more frequently as an adverse reaction in patients treated with BOTOX® (17% at 6 Units/kg and 10% at 3 Units/kg) compared to placebo (9%). In pediatric patients treated for lower limb spasticity, upper respiratory tract infection was not reported with an incidence greater than placebo.

Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity Associated with a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX® 200 Units compared with placebo (1.5% vs 0.4%, respectively).

Urinary Tract Infections in Patients with Overactive Bladder
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive bladder excluded patients with more than 2 UTIs in the past 6 months and those taking antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of overactive bladder in such patients and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh the potential risk.

Urinary Retention in Adults Treated for Bladder Dysfunction
Due to the risk of urinary retention, treat only patients who are willing and able to initiate catheterization posttreatment, if required, for urinary retention.

In patients who are not catheterizing, PVR urine volume should be assessed within 2 weeks posttreatment and periodically as medically appropriate up to 12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and continue until PVR falls below 200 mL. Instruct patients to contact their physician if they experience difficulty in voiding as catheterization may be required.

Overactive Bladder
In clinical trials, 6.5% of patients (36/552) initiated CIC for urinary retention following treatment with BOTOX® 100 Units, as compared to 0.4% of patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX® 100 Units was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo.

Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics. In clinical trials, 12.3% of patients (10/81) with diabetes developed urinary retention following treatment with BOTOX® 100 Units vs 0% of patients (0/69) treated with placebo. In patients without diabetes, 6.3% of patients (33/526) developed urinary retention following treatment with BOTOX ® 100 Units vs 0.6% of patients (3/516) treated with placebo.

Adult Detrusor Overactivity Associated with a Neurologic Condition
In clinical trials, 30.6% of adult patients (33/108) who were not using CIC prior to injection required catheterization for urinary retention following treatment with BOTOX® 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).

Among adult patients not using CIC at baseline, those with multiple sclerosis were more likely to require CIC post injection than those with spinal cord injury.

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries a remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), which would also be considered remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS
Adverse reactions to BOTOX® and BOTOX® Cosmetic for injection are discussed in greater detail in the following sections: Boxed Warning, Contraindications, and Warnings and Precautions.

Glabellar Lines
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

Lateral Canthal Lines
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).

Forehead Lines
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

Platysma Bands
The safety profile of BOTOX® Cosmetic treatment of platysma bands is consistent with the known safety profile of BOTOX® Cosmetic for other indications.

Overactive Bladder
The most frequently reported adverse reactions for overactive bladder occurring within 12 weeks of injection include UTI (BOTOX 18%, placebo 6%); dysuria (BOTOX® 9%, placebo 7%); urinary retention (BOTOX ® 6%, placebo 0%); bacteriuria (BOTOX® 4%, placebo 2%); and residual urine volume (BOTOX® 3%, placebo 0%).

A higher incidence of UTI was observed in patients with diabetes mellitus treated with BOTOX® 100 Units and placebo than nondiabetics.

The incidence of UTI increased in patients who experienced a maximum PVR urine volume ≥200 mL following BOTOX® injection compared to those with a maximum PVR <200 mL following BOTOX® injection, 44% vs 23%, respectively.

Adult Detrusor Overactivity Associated with a Neurologic Condition
The most frequently reported adverse reactions within 12 weeks of BOTOX® injection for detrusor overactivity associated with a neurologic condition include UTI (BOTOX® 24%, placebo 17%); urinary retention (BOTOX® 17%, placebo 3%); hematuria (BOTOX® 4%, placebo 3%).

The following adverse event rates were reported at any time following initial injection and prior to reinjection or study exit (median duration of 44 weeks of exposure): UTIs (49%), urinary retention (17%), constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance (3%), and muscle spasm (2%).

Pediatric Detrusor Overactivity Associated with a Neurologic Condition
The most frequently reported adverse reactions during the 12 weeks following BOTOX® injection of 200 Units for pediatric detrusor overactivity associated with a neurologic condition include bacteriuria (20%), UTI (7%), leukocyturia (7%), and hematuria (3%).

The most common adverse reactions in patients who received BOTOX® 6 Units/kg and less than a total dose of 200 Units were UTI, bacteriuria, and hematuria.

These patients were not adequately managed with at least one anticholinergic agent and were using CIC at baseline.

Chronic Migraine
The most frequently reported adverse reactions following injection of BOTOX® for chronic migraine vs placebo include, respectively: neck pain (9% vs 3%); headache (5% vs 3%); eyelid ptosis (4% vs <1%); migraine (4% vs 3%); muscular weakness (4% vs <1%); musculoskeletal stiffness (4% vs 1%); bronchitis (3% vs 2%); injection-site pain (3% vs 2%); musculoskeletal pain (3% vs 1%); myalgia (3% vs 1%); facial paresis (2% vs 0%); hypertension (2% vs 1%); and muscle spasms (2% vs 1%).

Adult Upper Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX® for upper limb spasticity include pain in extremity, muscular weakness, fatigue, nausea, and bronchitis.

Adult Lower Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX® for lower limb spasticity include arthralgia, back pain, myalgia, upper respiratory tract infection, and injection-site pain.

Pediatric Upper Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX® in pediatric upper limb spasticity include upper respiratory tract infection (includes upper respiratory tract infection and viral upper respiratory tract infection), injection-site pain, nausea, constipation, rhinorrhea, nasal congestion, and seizure (includes seizure and partial seizure).

Pediatric Lower Limb Spasticity
The most frequently reported adverse reactions following injection of BOTOX® in pediatric lower limb spasticity include injection-site erythema, injection-site pain, oropharyngeal pain, ligament sprain, skin abrasion, and decreased appetite.

Cervical Dystonia
The most frequently reported adverse reactions following injection of BOTOX® for cervical dystonia include dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%).

Blepharospasm
The most frequently reported adverse reactions following injection of BOTOX® for blepharospasm include ptosis (21%), superficial punctate keratitis (6%), and eye dryness (6%).

Strabismus
The most frequently reported adverse events following injection of BOTOX® for strabismus include ptosis (1% after inferior rectus injections, 16% after horizontal rectus injections, and 38% after superior rectus injections) and vertical deviation (17%).

Primary Axillary Hyperhidrosis
The most frequently reported adverse events (3%-10% of adult patients) following injection of BOTOX® for severe primary axillary hyperhidrosis in double-blind studies include injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

Postmarketing Experience
Adverse reactions that have been identified during postapproval use of BOTOX® are discussed in greater detail in Postmarketing Experience (Section 6.3 of the Prescribing Information).

There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin. There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors, including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established.

DRUG INTERACTIONS
Co-administration of BOTOX® or BOTOX® Cosmetic and other agents interfering with neuromuscular transmission (e.g., aminoglycosides, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® or BOTOX® Cosmetic may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® or BOTOX ® Cosmetic.

USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX ® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Please see BOTOX® full Prescribing Information, including Boxed Warning and Medication Guide.

Please see BOTOX® Cosmetic full Prescribing Information, including Boxed Warning and Medication Guide.

Natrelle® Breast Implants IMPORTANT SAFETY INFORMATION

Natrelle® Breast Implants are indicated for women for the following:

• Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery
• Breast reconstruction. This includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery

CONTRAINDICATIONS
Breast implant surgery should not be performed in:

• Women with active infection anywhere in their body
• Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
• Women who are currently pregnant or nursing

ADDITIONAL WARNINGS

• See Boxed Warning
• Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants. Use care when using surgical instruments in proximity with the breast implant
• Follow recommended fill volumes for saline implants to decrease possibility of shell wrinkling and crease-fold failure

PRECAUTIONS
Safety and effectiveness have not been established in patients with the following:

• Autoimmune diseases (e.g., lupus and scleroderma)
• A compromised immune system (e.g., currently receiving immunosuppressive therapy)
• Planned chemotherapy or radiation following breast implant placement
• Conditions or medications that interfere with wound healing and blood clotting
• Reduced blood supply to breast tissue
• Clinical diagnosis of depression or other mental health disorders, including body dysmorphic disorder and eating disorders. Please discuss any history of mental health disorders prior to surgery. Patients with a diagnosis of depression, or other mental health disorders, should wait until resolution or stabilization of these conditions prior to undergoing breast implantation surgery

ADVERSE EVENTS
Possible adverse events with breast implant surgery include implant rupture with silicone implants, implant deflation with saline-filled implants, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed wound healing, infection, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy. Other systemic conditions have been reported with breast implants.

For more information, please see the full Directions for Use at www.allergan.com/products.

To report a problem with Natrelle® Breast Implants, please call Allergan® at 1-800-624-4261.

The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Allergan®.

ALLODERM SELECT™ Regenerative Tissue Matrix

ALLODERM SELECT RESTORE™ Regenerative Tissue Matrix
Indications and Important Safety Information

INDICATIONS
ALLODERM SELECT™ Regenerative Tissue Matrix (ALLODERM SELECT™ RTM refers to both ALLODERM SELECT™ RTM and ALLODERM SELECT RESTORE™ RTM products) is intended to be used for repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. ALLODERM SELECT™ RTM may be used in certain post-mastectomy breast reconstruction surgical procedures where the use of the ADM is considered homologous. This product is intended for single patient one-time use only. ALLODERM SELECT™ RTM is not indicated for use as a dural substitute or intended for use in veterinary applications.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
ALLODERM SELECT™ RTM should not be used in patients with a known sensitivity to any of the antibiotics listed on the package and/or Polysorbate 20.

WARNINGS
Processing of the tissue, laboratory testing, and careful donor screening minimize the risk of the donor tissue transmitting disease to the recipient patient. As with any processed donor tissue, ALLODERM SELECT™ RTM is not guaranteed to be free of all pathogens. No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential or reproductive impact of the clinical application of ALLODERM SELECT™ RTM.

DO NOT re-sterilize ALLODERM SELECT™ RTM. DO NOT reuse once the tissue graft has been removed from the packaging and/or is in contact with a patient. Discard all open and unused portions of the product in accordance with standard medical practice and institutional protocols for disposal of human tissue. Once a package or container seal has been compromised, the tissue shall be either transplanted, if appropriate, or otherwise discarded. DO NOT use if the foil pouch is opened or damaged. DO NOT use if the seal is broken or compromised. DO NOT use if the temperature monitoring device does not display “OK.” DO NOT use after the expiration date noted on the label. Transfer ALLODERM SELECT™ RTM from the foil pouch aseptically. DO NOT place the foil pouch in the sterile field.

PRECAUTIONS
Poor general medical condition or any pathology that would limit the blood supply and compromise healing should be considered when selecting patients for implanting ALLODERM SELECT™ RTM as such conditions may compromise successful clinical outcome. Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures should be taken.

ALLODERM SELECT™ RTM has a distinct basement membrane (upper) and dermal surface (lower). When applied as an implant, it is recommended that the dermal side be placed against the most vascular tissue. Soak the tissue for a minimum of 2 minutes using a sterile basin and room temperature sterile saline or room temperature sterile lactated Ringer’s solution to cover the tissue. If any hair is visible, remove using aseptic technique before implantation.

ALLODERM SELECT™ RTM should be hydrated and moist when the package is opened. DO NOT use if this product is dry. Use of this product is limited to specific health professionals (e.g., physicians, dentists, and/or podiatrists). Certain considerations should be made to reduce the risk of adverse events when performing surgical procedures using a tissue graft. Please see the Instructions for Use (IFU) for more information on patient/product selection and surgical procedures involving tissue implantation before using ALLODERM SELECT™ RTM.

ADVERSE EVENTS
The most commonly reported adverse events associated with the implant of a tissue graft include, but are not limited to, the following: wound or systemic infection; seroma; dehiscence; hypersensitive, allergic or other immune response; and sloughing or failure of the graft.

ALLODERM SELECT™ RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ALLODERM SELECT™ RTM.

To report an adverse action, please call Allergan at 1.800.433.8871.

ARTIA™ RECONSTRUCTIVE TISSUE MATRIX INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

ARTIA™ Reconstructive Tissue Matrix (ARTIA™ RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. ARTIA™ RTM is supplied sterile and is intended for single patient, one time use only.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. ARTIA™ Tissue Matrix cannot be reused once it has been removed from the packaging and/or is in contact with a patient without increased risk of patient-to-patient contamination and subsequent infection. The user should be aware of high recurrence rates when using a surgical mesh for bridging repair in load-bearing applications (e.g., hernia repair).

PRECAUTIONS
Use of the product in breast reconstruction has not been studied in a prospective clinical trial.

Discard product if handling has caused possible damage or contamination, or the product is past the expiration date. Ensure the surgical mesh is soaked in room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use. If a tissue punch-out piece is visible, remove using aseptic technique before implantation.

Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities, including, but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.

ARTIA™ RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for ARTIA™ RTM.

For product complaints and potential adverse events, please contact your local Sales Representative, or 1.800.433.8871.

CoolSculpting® and CoolSculpting® Elite Professional ISI

Indications
CoolSculpting® and CoolSculpting® Elite are FDA-cleared for the treatment of visible fat bulges in the thigh, abdomen, and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm in patients with a Body Mass Index (BMI) of ≤ 30 and in submental and submandibular areas in patients with a BMI of ≤ 46.2. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.

Important Safety Information
CoolSculpting® and CoolSculpting® Elite are contraindicated in patients with cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Ask your patient about any medical conditions including pregnancy, recent surgery, pre-existing hernia, and any known sensitivities or allergies. Avoid treatments near/over implants, such as pacemakers, defibrillators, breast or buttock implants.

During the procedure patients may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, cramping, and discomfort at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, stinging, tenderness, cramping, skin inflammation, and aching. Sensory alteration (itching, skin sensitivity, tingling, and numbness) can persist up to several weeks after treatment. Patients may also experience throat discomfort/soreness and sensation of fullness in the back of the throat after submental or submandibular area treatment.

Rare side effects may also occur. Paradoxical hyperplasia (visibly enlarged tissue volume in the treated area) may develop 2 to 5 months after treatment, will not resolve on its own, and may require surgical intervention for correction.

As with any medical procedure, a consultation should be done by a licensed healthcare professional to determine if the patient is a candidate for treatment. For a complete list of Contraindications, Warnings, Precautions, and Potential Side Effects, consult the CoolSculpting® System User Manual and the CoolSculpting® Elite System User Manual. Treatment applications that deviate from the guidelines are not recommended.

CoolTone® Important Information

Indications
The CoolTone® device is indicated for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone® is also indicated for strengthening, toning, and firming of buttocks and thighs.

Important Safety Information
CoolTone® treatment is contraindicated in placing the active applicator over metal, electrical, or electronic implants/devices in the treatment area like cardiac pacemakers, cochlear implants, intrathecal pumps, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.

CoolTone® is also contraindicated in placing the active applicator over menstruating uterus, over areas of the skin that lack normal sensation, and in patients with fever, malignant tumor, hemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.

CoolTone® should be used with caution in patients with Graves’ disease, active bleeding disorders, or seizure disorders.

Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments, therefore, it is recommended to not undergo treatment during this time of the month.

CoolTone® should not be used in the heart or head areas, areas of growth plate, over the carotid sinus nerves, or over the neck or mouth. CoolTone® should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.

Ensure that persons with pacemakers are not present in vicinity of the device during treatment.

Common adverse effects may include, but may not be limited to muscular pain, temporary muscle spasm, temporary joint or tendon pain, and local erythema or skin redness.

Consult the CoolTone® User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects. Treatment applications that deviate from the guidelines are not recommended.

DALVANCE® (dalbavancin) 500 mg injection Important Information

INDICATION AND USAGE
DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

Contraindications
DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions

Hypersensitivity Reactions
Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity. If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions
Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, rash, and/or back pain.

Hepatic Effects
ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridioides difficile-associated Diarrhea
Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria
Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions
The most common adverse reactions in adult patients treated with DALVANCE in Phase 2/3 trials were nausea (5.5%), headache (4.7%), and diarrhea (4.4%). The most common adverse reaction that occurred in more than 1% of pediatric patients was pyrexia (1.2%).

Use in Specific Populations

• There have been no adequate and well-controlled studies with DALVANCE use in pregnant or nursing women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for DALVANCE and any adverse effects on the breast-fed child from DALVANCE or from the underlying maternal condition.
• In patients with renal impairment whose known creatinine clearance (CLcr) is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended regimen of DALVANCE is 1125 mg, administered as a single dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis. There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years of age with CLcr less than 30 mL/min/1.73m2.
• Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

Please click here for full DALVANCE® Prescribing Information.

DiamondGlow® Important Information

INDICATION AND USE

The DiamondGlow® device is indicated for general dermabrasion of the skin and also delivers topical cosmetic serums onto the skin.

IMPORTANT SAFETY INFORMATION

DiamondGlow® is contraindicated in patients who have compromised skin quality, including but not limited to sunburned, chapped, irritated or broken skin; open wounds; active, weeping acne; cold sores; or herpetic ulcers. Ask your patient if they are pregnant or lactating or if they have any medical conditions, including allergies, and usage of topical medication on the area to be treated.

Typical side effects include a scratchy, stinging sensation during the treatment and temporary tightness, redness or slight swelling after the treatment. Rare serious side effects may also occur and include severe skin irritation and allergic reactions. Cease use of the device immediately if any of these serious side effects are observed.

Patients should be advised to use a sunscreen with a sun protection factor of 30 or higher following treatment.

Consult the DiamondGlow® User Manual for a complete list of Contraindications, Warnings, Precautions, and potential side effects.

SKINMEDICA® PRO-INFUSION SERUMS DISCLAIMER

SkinMedica® Pro-Infusion Serums are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These products are not intended to be drugs that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.

DURYSTA® Indications and Usage and Important Safety Information

Indications and Usage

DURYSTA® (bimatoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Important Safety Information

Contraindications

DURYSTA® is contraindicated in patients with: active or suspected ocular or periocular infections; corneal endothelial cell dystrophy (e.g., Fuchs’ Dystrophy); prior corneal transplantation or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]); absent or ruptured posterior lens capsule, due to the risk of implant migration into the posterior segment; hypersensitivity to bimatoprost or to any other components of the product.

Warnings and Precautions

The presence of DURYSTA® implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Administration of DURYSTA® should be limited to a single implant per eye without retreatment. Caution should be used when prescribing DURYSTA® in patients with limited corneal endothelial cell reserve.

DURYSTA® should be used with caution in patients with narrow iridocorneal angles (Shaffer grade < 3) or anatomical obstruction (e.g., scarring) that may prohibit settling in the inferior angle.

Macular edema, including cystoid macular edema, has been reported during treatment with ophthalmic bimatoprost, including DURYSTA® intracameral implant. DURYSTA® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Prostaglandin analogs, including DURYSTA®, have been reported to cause intraocular inflammation. DURYSTA® should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Ophthalmic bimatoprost, including DURYSTA® intracameral implant, has been reported to cause changes to pigmented tissues, such as increased pigmentation of the iris. Pigmentation of the iris is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. While treatment with DURYSTA® can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

Intraocular surgical procedures and injections have been associated with endophthalmitis. Proper aseptic technique must always be used with administering DURYSTA®, and patients should be monitored following the administration.

Adverse Reactions

In controlled studies, the most common ocular adverse reaction reported by 27% of patients was conjunctival hyperemia. Other common adverse reactions reported in 5%-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, iritis, and headache.

Please see full Prescribing Information available here or at DurystaHCP.com

JUVÉDERM® Collection of Fillers Important Information

INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.

JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.

JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.

JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
These products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.

WARNINGS

• Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled

PRECAUTIONS

• To minimize the risk of potential complications, these products should only be used by healthcare professionals who are knowledgeable about the anatomy and the product(s) for use in indicated area(s), and who have appropriate training in facial anatomy, vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
• The potential risk of soft tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
• The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each product have not been established in controlled clinical studies
• The safety for use of these products in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• The safety for use during pregnancy and in breastfeeding females has not been established
• The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age for cheek augmentation and in patients between 22 and 80 years of age for chin augmentation
• The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and the safety for use of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE ® XC, and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
• Dermal filler implantation carries a risk of infection. Follow standard precautions
• Dermal fillers should be used with caution in patients on immunosuppressive therapy
• Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
• The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
• The safety for use of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
• JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
• The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
• Patients may experience late-onset adverse events with injectable gel implants, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
• Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (132 lb) body mass per year. The safety of injecting greater amounts has not been established
• Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied

ADVERSE EVENTS
The most common reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA ® XC, dryness was also reported. The majority were mild or moderate in severity.

To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support at 1-877-345-5372. Please visit JuvedermDFU.com for more information.

Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.

The most updated versions of the JUVÉDERM® Collection of Fillers patient labels and directions for use can be found here.

KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information

INDICATION
KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
KYBELLA® is contraindicated in the presence of infection at the injection sites.

WARNINGS AND PRECAUTIONS
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.

Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, e.g., pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.

Injection Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.

Risk of Injecting into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Care should be taken to avoid inadvertent injection directly into an artery or a vein as it can result in vascular injury.

Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.

Injection Site Ulceration, Necrosis, and Infection
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration, necrosis, and infection have been reported with administration of KYBELLA®. Some cases of injection site infection have included cellulitis and abscess requiring antibiotic treatment and incision and drainage. Do not administer KYBELLA® into affected area until complete resolution.

ADVERSE REACTIONS
The most commonly reported adverse reactions in the pivotal clinical trials were injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.

Please see KYBELLA® full Prescribing Information.

LATISSE® (bimatoprost ophthalmic solution) 0.03% Important Information

Indication

LATISSE® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth, including length, thickness, and darkness.

Important Safety Information

Contraindications: LATISSE® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients.

Warnings and Precautions: In patients using LUMIGAN® (bimatoprost ophthalmic solution) or other prostaglandin analogs for the treatment of elevated intraocular pressure (IOP), the concomitant use of LATISSE® may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN® for IOP reduction should only use LATISSE® after consulting with their physician and should be monitored for changes to their intraocular pressure.

Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation, which is likely to be permanent.

Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered but has been reported to be reversible upon discontinuation of bimatoprost in most patients.

There is the potential for hair growth to occur in areas where LATISSE® solution comes in repeated contact with skin surfaces. Apply LATISSE® only to the skin of the upper eyelid margin at the base of the eyelashes.

LATISSE® solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. LATISSE® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Adverse Reactions: The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema. These reactions occurred in less than 4% of patients.

Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), trichiasis, and vision blurred.

Please see LATISSE® full Prescribing Information.

LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg Important Information

INDICATION

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 8 years. The system should be replaced after 8 years if continued use is desired.

IMPORTANT SAFETY INFORMATION

Who is not appropriate for LILETTA

Use of LILETTA is contraindicated in women with the following: pregnancy; for use as post-coital contraception; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine system (IUS) placement; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis), until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; a current IUS; acute pelvic inflammatory disease (PID); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA.

Clinical considerations for use and removal of LILETTA

Use LILETTA with caution after careful assessment in women with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing LILETTA if the following arise during use: uterine or cervical malignancy or jaundice. Because irregular bleeding/spotting is common during the first months of LILETTA use, exclude endometrial pathology (polyps or cancer) prior to the insertion of LILETTA in women with persistent or uncharacteristic bleeding. If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If LILETTA is displaced (e.g., expulsed or perforated the uterus), remove it.

Pregnancy-related risks with LILETTA

If pregnancy should occur with LILETTA in place, remove the IUS because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy.

Educate her about PID or endometritis

Insertion of LILETTA is contraindicated in the presence of known or suspected PID or endometritis. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. One woman diagnosed with PID and two women diagnosed with endometritis developed the infection within a week of insertion. One endometritis case was diagnosed at 39 days after insertion. The remaining 11 cases of PID and endometritis were diagnosed more than 6 months after insertion, including one at 30 days after IUS removal. Counsel women who use LILETTA to notify a healthcare provider if they develop lower abdominal or pelvic pain, fever, chills, unusual or malodorous discharge, unexplained bleeding, genital lesions or sores, or dyspareunia. PID and endometritis are often associated with sexually transmitted infections (STIs); LILETTA does not protect against STIs, including HIV. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Inform women about the possibility of PID or endometritis and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.

Expect changes in bleeding patterns with LILETTA

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation. If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology.

Be aware of other serious complications and most common adverse reactions.

Some serious complications with IUSs like LILETTA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of LNG-releasing IUSs. Aseptic technique during insertion of LILETTA is essential to minimize serious infections such as GAS.

Perforation (total or partial, including penetration/embedment of LILETTA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may also occur at any time during use. Perforation may reduce contraceptive efficacy. If perforation is suspected, locate and remove LILETTA as soon as possible. Surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is increased if inserted in women who have fixed retroverted uteri, are postpartum, or are lactating. Delay LILETTA insertion a minimum of 4 weeks or until uterine involution is complete following a delivery or a second-trimester abortion.

Partial or complete expulsion of LILETTA may occur, resulting in the loss of contraceptive protection. Expulsion risk is increased when inserted immediately after delivery; it appears to be increased with insertions after second-trimester abortion, based on limited data. Remove a partially expelled LILETTA. If expulsion has occurred, a new LILETTA may be inserted when there is reasonable certainty the patient is not pregnant.

Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic or abdominal pain or dyspareunia. Evaluate persistent ovarian cysts.

Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic or abdominal pain or dyspareunia. Evaluate persistent ovarian cysts.

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Consider evaluating patients 4 to 6 weeks after LILETTA insertion and during routine care, or more often if clinically indicated. Check threads during each evaluation.

OZURDEX® (dexamethasone intravitreal implant) Important Information

Indications and Usage

Diabetic Macular Edema
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of diabetic macular edema.

Retinal Vein Occlusion
OZURDEX® is a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.

Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8.

Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX® use.

Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions

Intravitreal Injection-related Effects: Intravitreal injections, including those with OZURDEX®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.

Steroid-related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

Adverse Reactions
Retinal Vein Occlusion and Posterior Segment Uveitis
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).

Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.

Diabetic Macular Edema
Ocular adverse reactions reported by greater than or equal to 1% of patients in the two combined 3-year clinical trials following injection of OZURDEX® for diabetic macular edema include: cataract (68%), conjunctival hemorrhage (23%), visual acuity reduced (9%), conjunctivitis (6%), vitreous floaters (5%), conjunctival edema (5%), dry eye (5%), vitreous detachment (4%), vitreous opacities (3%), retinal aneurysm (3%), foreign body sensation (2%), corneal erosion (2%), keratitis (2%), anterior chamber inflammation (2%), retinal tear (2%), eyelid ptosis (2%). Non-ocular adverse reactions reported by greater than or equal to 5% of patients include: hypertension (13%) and bronchitis (5%).

Increased Intraocular Pressure: IOP elevation greater than or equal to 10 mm Hg from baseline at any visit was seen in 28% of OZURDEX® patients versus 4% of sham patients. 42% of the patients who received OZURDEX® were subsequently treated with IOP-lowering medications during the study versus 10% of sham patients.

The increase in mean IOP was seen with each treatment cycle, and the mean IOP generally returned to baseline between treatment cycles (at the end of the 6-month period).

Cataracts and Cataract Surgery: The incidence of cataract development in patients who had a phakic study eye was higher in the OZURDEX® group (68%) compared with Sham (21%). The median time of cataract being reported as an adverse event was approximately 15 months in the OZURDEX® group and 12 months in the Sham group. Among these patients, 61% of OZURDEX® subjects versus 8% of sham-controlled subjects underwent cataract surgery, generally between Month 18 and Month 39 (Median Month 21 for OZURDEX® group and 20 for Sham) of the studies.

Please click here for full OZURDEX® Prescribing Information.

REVOLVE™ Advanced Adipose System Indications and Important Safety Information

INDICATIONS
The REVOLVE™ Advanced Adipose System (REVOLVE™ System) is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. REVOLVE™ System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Contraindications to autologous fat transfer include the presence of any disease processes that adversely affect wound healing, and poor overall health status of the individual.

WARNINGS
REVOLVE™ System must be used within the same surgical procedure. Reuse of this device in the same patient in a subsequent surgical procedure, or for more than one patient, may result in infection and/or transmission of communicable diseases. Do not use the product if sterile packaging is damaged.

This device will not, in and of itself, produce significant weight reduction. This device should be used with extreme caution in patients with chronic medical conditions such as diabetes, heart, lung, or circulatory system disease or obesity. The volume of blood loss and endogenous body fluid loss may adversely affect intra and/or postoperative hemodynamic stability and patient safety. The capability of providing adequate, timely replacement is essential for patient safety.

PRECAUTIONS
REVOLVE™ System is designed to remove localized deposits of excess fat through small incision and subsequently transfer the tissue back to the patient. Use of this device is limited to those physicians who, by means of formal professional training or sanctioned continuing medical education (including supervised operative experience), have attained proficiency in suction lipoplasty and tissue transfer. Results of this procedure will vary depending upon patient age, surgical site, and experience of the physician. Results of this procedure may or may not be permanent. The amount of fat removed should be limited to that necessary to achieve a desired cosmetic effect. Filling the device with adipose tissue over the maximum fill volume line can lead to occlusion of the mesh resulting in mesh tear.

ADVERSE EFFECTS
Some common adverse effects associated with autologous fat transfer are asymmetry, over- and/or under-correction of the treatment site, tissue lumps, bleeding, and scarring. Potential adverse effects associated with REVOLVE™ System include fat necrosis, cyst formation, infection, chronic foreign body response, allergic reaction, and inflammation.

REVOLVE™ System is available by prescription only.

For more information, please see the Instructions for Use (IFU) and User Manual for REVOLVE™ System available at www.allergan.com/RevolveIFU or call 1.800.678.1605.

To report an adverse action, please call Allergan at 1.800.367.5737.

SkinMedica® Disclaimer

Most SkinMedica® products are intended to meet the FDA’s definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica ® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA and the statements have not been evaluated by the FDA.

SkinMedica® Total Defense + Repair Broad Spectrum Sunscreens (SPF 34 and SPF 34 Tinted) and Essential Defense Broad Spectrum Sunscreens (Everyday Clear SPF 47, Mineral Shield Tinted SPF 32, and Mineral Shield SPF 35) are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 352.

SkinMedica® Purifying Foaming Wash and Acne Clarifying Treatment are over-the-counter drug products which are formulated and marketed pursuant to FDA’s governing regulations set forth at 21 CFR Part 333 Subpart D.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

SKINVIVE by JUVÉDERM® Important Information

INDICATIONS
SKINVIVE by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.

WARNINGS

• Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
• Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
• Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS

PRECAUTIONS

• To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
• Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
• Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
• This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
• Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
• As with all transcutaneous procedures, injections of the product carry a risk of infection
• The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
• This product should be used with caution in patients on immunosuppressive therapy
• Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• Patients may experience late onset AEs with use of injectable gel implants, including this product
• This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site

ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.

To report an adverse reaction with SKINVIVE by JUVÉDERM®, please call the Allergan® Product Support Department at 1-877-345-5372. Please see Directions for Use or visit SKINVIVEDFU.com for more information.

SKINVIVE by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.

STRATTICE™ BPS RECONSTRUCTIVE TISSUE MATRIX INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

STRATTICE™ BPS Reconstructive Tissue Matrix (STRATTICE™ BPS RTM) is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery. STRATTICE™ BPS RTM is supplied as sterile and is intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
This product should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS
Do not resterilize. Discard all open and unused portions of this device. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. Do not use if the temperature monitoring device does not display “OK.” Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

PRECAUTIONS
Discard product if mishandling has caused possible damage or contamination, or the product is past its expiration date. Ensure the surgical mesh is placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place the product in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. The surgical mesh should be hydrated and moist when the package is opened. If the product is dry, do not use.

Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.

Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh.

STRATTICE™ BPS RTM is available by prescription only.

For more information, please see the Instructions for Use (IFU) for STRATTICE™ BPS RTM.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

STRATTICE™ RECONSTRUCTIVE TISSUE MATRIX (RTM), STRATTICE™ RTM PERFORATED, STRATTICE™ RTM EXTRA THICK, AND STRATTICE™ RTM LAPAROSCOPIC
COMBINED INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20.

WARNINGS
Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-to-patient contamination and subsequent infection.

For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.”

PRECAUTIONS
Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.

Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation.
Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure.

For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation.

For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar.

STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only.

For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products.

To report an adverse reaction, please call Allergan at 1.800.367.5737.

TEFLARO® (ceftaroline fosamil) for injection Important Information

INDICATIONS AND USAGE

• TEFLARO® (ceftaroline fosamil) is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age and older) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
• TEFLARO is also indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

IMPORTANT SAFETY INFORMATION

Contraindications

• TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline.

Warnings and Precautions

Hypersensitivity Reactions

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterial drugs. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been clearly established.
• If an allergic reaction to TEFLARO occurs, discontinue TEFLARO and institute appropriate treatment and supportive measures.

Clostridioides difficile-Associated Diarrhea

• Clostridioides difficile-Associated Diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.

Neurological Adverse Reactions

• Neurological adverse reactions have been reported during postmarketing surveillance in patients treated with cephalosporins, including TEFLARO. These reactions include encephalopathy and seizures. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. The neurological adverse reactions were reversible and resolved after discontinuation of TEFLARO or after hemodialysis. If neurological adverse reactions associated with TEFLARO therapy occur, consider discontinuing TEFLARO or making appropriate dosage adjustments in patients with renal impairment.

Direct Coombs’ Test Seroconversion

• In adults, seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled adult Phase 3 trials.
• In children, seroconversion from a negative to a positive direct Coombs’ test result occurred in 42/234 (17.9%) of patients receiving TEFLARO and 3/93 (3.2%) of patients receiving comparator drugs in the three pooled pediatric trials.
• No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.

Development of Drug-Resistant Bacteria

• Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions in Adults

• In the four pooled adult Phase 3 clinical trials, serious adverse reactions occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.
• The most common adverse reactions occurring in >2% of patients receiving TEFLARO in the adult pooled Phase 3 clinical trials were diarrhea (5%), nausea (4%), and rash (3%).

Adverse Reactions in Pediatrics

• In the three pooled pediatric clinical trials, serious adverse reactions occurred in 10/257 (4%) of patients receiving TEFLARO and 3/102 (3%) of patients receiving comparator drugs. Treatment discontinuation due to adverse reactions occurred in 10/257 (3.9%) of patients receiving TEFLARO and 2/102 (2%) of patients receiving comparator drugs with the most common adverse reaction leading to discontinuation being rash in 2/257 (0.8%) of patients treated with TEFLARO.
• The most common adverse reactions occurring in ≥ 3% of patients receiving TEFLARO in the pooled pediatric clinical trials were diarrhea (8%), rash (7%), vomiting (5%), pyrexia (3%), and nausea (3%).

Drug Interactions

• No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drug-drug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

Use in Specific Populations

• There have been no adequate and well-controlled studies with TEFLARO in pregnant or nursing women. TEFLARO should only be used if the potential benefit justifies the potential risk in these populations.
• Safety and effectiveness of TEFLARO for the treatment of ABSSSI in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age have not been established. Safety and effectiveness for the treatment of CABP in pediatric patients below the age of 2 months have not been established as no data are available.
• Because elderly patients, those ≥ 65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group, and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.
• Dosage adjustment is required in adult patients with moderate (CrCl >30 to ≤ 50 mL/min) or severe (CrCl ≥ 15 to ≤ 30mL/min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min). There is insufficient information to recommend a dosage regimen for pediatric patients with CrCl <50 mL/min/1.73m2.
• The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.