Botox® — Important Safety Information (ISI)

Read this information carefully before receiving Botox treatment. Discuss any questions or concerns with your provider.

What Is Botox?

Botox® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, frown lines between the eyebrows, and crow’s feet lines in adults. It is also FDA-approved for chronic migraine prevention, primary axillary hyperhidrosis (excessive underarm sweating), cervical dystonia, and several other medical conditions.

Boxed Warning — Spread of Toxin Effects

WARNING: DISTANT SPREAD OF TOXIN EFFECT. The effects of Botox and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

Contraindications

Botox is contraindicated in patients with:

• Known hypersensitivity to any botulinum toxin preparation or to any of the components of Botox
• Infection at the proposed injection site(s)

Warnings and Precautions

• Spread of Toxin Effect: See Boxed Warning above. Immediate medical attention is required if swallowing, speech, or respiratory disorders occur.
• Lack of Interchangeability: Units of Botox are not interchangeable with other preparations of botulinum toxin products and cannot be compared or converted into units of any other botulinum toxin product.
• 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.
• Cardiovascular System: Rare cases of arrhythmia and myocardial infarction have been reported following administration of Botox. Use caution in patients with pre-existing cardiovascular disease.
• Corneal Exposure: Reduced blinking from Botox injection of the orbicularis muscle can lead to corneal exposure. Use caution in patients with reduced corneal sensitivity, eyelid disorders, or prior ocular surgery.
• Pre-existing Neuromuscular Disorders: Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome).
• Human Albumin and Transmission of Viral Diseases: This product contains albumin, a derivative of human blood.

Most Common Adverse Reactions

The most commonly reported adverse reactions in cosmetic use include:

• Headache
• Eyelid ptosis (drooping)
• Brow ptosis
• Facial paresis
• Injection site reactions (bruising, swelling, redness)
• Nausea
• Dry eye

For non-cosmetic indications, adverse reactions vary by indication. Consult your provider or the full prescribing information.

Drug Interactions

Co-administration of Botox and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like nondepolarizing blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) should only be performed with caution as the effect of botulinum toxin may be potentiated.

The effect of administering different botulinum toxin 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.

Use in Specific Populations

• Pregnancy: Botox is not recommended during pregnancy. Based on animal data, Botox may cause fetal harm. Advise patients of the potential risk to a fetus.
• Lactation: There is no information on the presence of Botox in human milk. The developmental and health benefits of breastfeeding should be considered along with the clinical need.
• Pediatric Use: Safety and effectiveness for cosmetic indications have not been established in patients under 18 years.
• Geriatric Use: Clinical studies did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently from younger patients.

Full Prescribing Information

This ISI is a summary. Full prescribing information including dosing, administration, and clinical study data is available in the Botox package insert and at allergan.com. Discuss any questions with Dr. Ashar before your treatment.