Jeuveau® Sourcing for Credentialed Healthcare Providers

Contraindications

Jeuveau® should not be used in patients who:

• Have a known hypersensitivity to any botulinum toxin preparation or any component of Jeuveau®
• Have an infection at the proposed injection site(s)

Warnings and Precautions

Spread of Toxin Effect Botulinum toxin effects may occur beyond the injection site. Symptoms may include weakness, double vision, drooping eyelids, difficulty swallowing, voice or speech changes, urinary incontinence, blurred vision, and breathing difficulties. These symptoms may develop hours to weeks after treatment. Immediate medical care should be sought for swallowing, speech, or breathing problems.

Botulinum Toxin Products Are Not Interchangeable The potency units used for Jeuveau® are specific to this product and its testing method. They cannot be directly compared with or converted to units used for other botulinum toxin products.

Serious Adverse Reactions With Unapproved Use Serious reactions have been reported when botulinum toxin products were used for unapproved purposes. These have included excessive weakness, difficulty swallowing, and aspiration pneumonia, with some fatal outcomes. Some affected patients had pre-existing swallowing difficulties or other significant medical conditions.

Hypersensitivity Reactions Serious or immediate allergic reactions have been reported with botulinum toxin products. These may include anaphylaxis, serum sickness, hives, swelling of soft tissues, and difficulty breathing. If a serious hypersensitivity reaction occurs, Jeuveau® should be discontinued and appropriate medical treatment started immediately.

Cardiovascular Effects Cardiovascular events, including abnormal heart rhythms and myocardial infarction, have been reported following administration of botulinum toxins. Some cases have been fatal. Caution should be used in patients with pre-existing cardiovascular disease.

Pre-existing Neuromuscular Disorders Patients with peripheral motor neuropathic disease, amyotrophic lateral sclerosis, or neuromuscular junction disorders such as myasthenia gravis or Lambert-Eaton syndrome may be at greater risk of clinically significant effects from Jeuveau®. These may include generalized muscle weakness, double vision, drooping eyelids, voice or speech difficulties, severe difficulty swallowing, and respiratory compromise.

Difficulty Swallowing or Breathing Treatment with botulinum toxin products, including Jeuveau®, can cause swallowing or breathing difficulties. Patients who already have swallowing or breathing problems may be more susceptible to these complications.

Pre-existing Conditions at the Injection Site Jeuveau® should be used with caution when inflammation is present at the proposed injection site or when there is excessive weakness or atrophy of the target muscle. Caution is also advised in patients with marked facial asymmetry, drooping eyelids, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inadequate response to the recommended amount of botulinum toxin. The recommended dose and frequency of administration should not be exceeded.

Ophthalmic Adverse Reactions Dry eye has been reported with botulinum toxin treatment of glabellar lines. Reduced tear production, reduced blinking, and corneal problems may also occur. Patients with persistent eye irritation, sensitivity to light, or visual changes should be evaluated appropriately, including referral to an ophthalmologist when indicated.

Human Albumin Jeuveau® contains albumin derived from human blood. Modern donor screening and manufacturing processes make the risk of transmitting viral diseases extremely remote. The theoretical risk of transmitting Creutzfeldt-Jakob disease is also considered extremely remote, and transmission of viral disease or CJD through albumin has not been reported.

Adverse Reactions

The most frequently reported adverse reactions following treatment with Jeuveau® were:

• Headache (12%)
• Upper respiratory tract infection (3%)
• Eyelid ptosis (2%)
• Increased white blood cell count (1%)

Drug Interactions

Formal drug-interaction studies have not been conducted with Jeuveau®. Caution should be used with medications that may increase its effects, including aminoglycosides or other agents that interfere with neuromuscular transmission, anticholinergic drugs, other botulinum neurotoxin products, and muscle relaxants.

Use in Specific Populations

Available information about Jeuveau® use during pregnancy is limited and is not sufficient to determine the risk of adverse developmental outcomes.

There are no available data establishing whether Jeuveau® is present in human or animal milk, whether it affects a breastfed infant, or whether it affects milk production.

The safety and effectiveness of Jeuveau® in pediatric patients have not been established.

Indication

Jeuveau® (prabotulinumtoxinA-xvfs) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Full Prescribing Information

This information does not include all information necessary for the safe and effective use of Jeuveau®. For complete product information, please review the Full Prescribing Information, including Boxed Warning and Medication Guide .