Jeuveau Generic Name & Formulations
Legal Class
Rx
General Description
PrabotulinumtoxinA-xvfs 100 Units; per vial; vacuum-dried pwd for IM inj after reconstitution; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Jeuveau Indications
Indications
Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.
Jeuveau Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Do not exceed recommended dose and frequency. Avoid inj near the levator palpebrae superioris or closer than 1cm above central eyebrow. Give 4 Units/0.1mL IM into each of 5 sites (2 in each corrugator muscle and 1 in the procerus muscle); total of 20 Units/0.5mL per treatment session. Repeat treatment no sooner than every 3 months.
Children
Not established.
Jeuveau Contraindications
Contraindications
Infection at proposed inj site.
Jeuveau Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Jeuveau Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity); see full labeling. Increased risk of serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing cardiovascular disease, dysphagia, or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome). Compromised respiratory function. Presence of inflammation (proposed inj site), excessive weakness or atrophy at the target muscle. Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin or those unresponsive to 20 Units of botulinum toxin. Monitor for ocular effects or visual changes; refer to ophthalmologist if persist. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.
Jeuveau Pharmacokinetics
See Literature
Jeuveau Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May be affected by concomitant anticholinergic drugs, botulinum toxin products or muscle relaxants.
Jeuveau Adverse Reactions
Adverse Reactions
Headache, eyelid ptosis, upper respiratory tract infection, increased WBC count, local inj reactions (eg, pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising); hypersensitivity reactions (discontinue if occur), dry eye, dysphagia, breathing difficulties.
Jeuveau Clinical Trials
See Literature
Jeuveau Note
Not Applicable
Jeuveau Patient Counseling
See Literature