Important safety information for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA). Please read before treatment.
At Skin Deep Clinical Skin Care & Day Spa, all injectable treatments are performed by our licensed RN injector and require a consultation. The information below is provided by Allergan Aesthetics, the maker of BOTOX®, and is shared here for your awareness. It is not a substitute for the full Prescribing Information or for the medical advice of your provider. Please discuss your health history and any questions with our team before treatment.
Indications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, lateral canthal lines, forehead lines, and platysma bands associated with the underlying facial muscle activity in adults. BOTOX® (onabotulinumtoxinA) for injection is also indicated for a number of therapeutic conditions, including overactive bladder, chronic migraine, spasticity, cervical dystonia, blepharospasm, strabismus, and severe underarm sweating (primary axillary hyperhidrosis).
Important safety information, including boxed warning
Distant spread of toxin effect
Postmarketing reports indicate that the effects of BOTOX® and BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia (weakness), generalized muscle weakness, double vision, drooping eyelids, difficulty swallowing, difficulty speaking, loss of bladder control, and breathing difficulties. Symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk is likely greatest in children treated for spasticity, but symptoms can also occur in adults, particularly in those who have underlying conditions that would predispose them to these symptoms.
Contraindications
BOTOX® and BOTOX® Cosmetic should not be used if you:
- Have an infection at the proposed injection site.
- Are allergic to any botulinum toxin product or to any of the ingredients in the formulation.
- For bladder injection: have a urinary tract infection, are unable to empty your bladder on your own and are not routinely catheterizing, or have urinary retention.
Warnings and precautions
- Seek immediate medical care if you develop difficulty swallowing, speaking, or breathing after treatment.
- Not interchangeable. The dose units of BOTOX® are specific to the product and are not interchangeable with other botulinum toxin products.
- Serious reactions with unapproved use. Serious adverse reactions, including excessive weakness, difficulty swallowing, and aspiration pneumonia, have been reported with unapproved uses, some with fatal outcomes.
- Hypersensitivity reactions. Serious and immediate allergic reactions have been reported, including anaphylaxis, serum sickness, hives, soft-tissue swelling, and shortness of breath. Tell your provider about any prior reactions.
- Cardiovascular events. There have been reports of cardiovascular events, including irregular heartbeat and heart attack, some fatal. Use caution if you have a preexisting cardiovascular condition.
- Preexisting neuromuscular disorders. Individuals with conditions such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects, including severe swallowing and breathing difficulties.
- Human albumin. This product contains albumin, a derivative of human blood. Based on effective donor screening and manufacturing processes, it carries an extremely remote risk of transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission have ever been identified for licensed albumin products.
Common adverse reactions
The most common side effects associated with the cosmetic use of BOTOX® Cosmetic include eyelid drooping, eyebrow drooping, eyelid swelling, headache, and injection-site reactions such as pain, redness, or bruising. The specific reactions and their frequency vary by treatment area.
Drug interactions
Tell your provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Certain medicines, such as some antibiotics, muscle relaxants, anticholinergic drugs, and other botulinum toxin products, may interact with BOTOX® and increase your risk of side effects.
Use in specific populations
The effects of BOTOX® Cosmetic on a developing baby, on breastfed infants, or on milk production are not known. Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
For more information
This is a summary of important safety information and does not include everything you need to know. For the full Prescribing Information and Medication Guide, please talk with your provider or visit the resources provided by Allergan. If you have questions about whether an injectable treatment is right for you, please call us at (254) 680-7546 and schedule a consultation.