PrabotulinumtoxinA-xvfs

What is PrabotulinumtoxinA-xvfs?

PrabotulinumtoxinA-xvfs (JEUVEAU) is an acetylcholine release inhibitor and a neuromuscular blocking agent.

What are the uses of this medicine?

This medicine is injected into muscles and used in adults for a short period of time (temporary) to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines).

How does this medicine work?

• JEUVEAU blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine.
• This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings.
• When injected intramuscularly at therapeutic doses, JEUVEAU produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
• In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop.
• There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by JEUVEAU.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
• Infection at the injection site.

What drug interactions can this medicine cause?

No formal drug interaction studies have been conducted with JEUVEAU (prabotulinumtoxinA-xvfs). Closely observe patients receiving concomitant treatment of JEUVEAU with:

• Aminoglycosides or other agents interfering with neuromuscular transmission
• Anticholinergic drugs
• Botulinum neurotoxin products
• Muscle relaxant

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units.

Administration

• JEUVEAU is an injection that your healthcare provider will give you.
• JEUVEAU is injected into your affected muscles.
• JEUVEAU should not be received more than 1 time every 3 months.
• Your healthcare provider may change your dose of JEUVEAU, until you and your healthcare provider find the best dose for you.
• Your healthcare provider will tell you how often you will receive your dose of JEUVEAU injections.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 Units vacuum-dried powder in a single-dose vial

This medicine is available in fallowing brand namesː

• JEUVEAU

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• eyelid drooping
• upper respiratory infection
• increased white blood cell count in your blood

JEUVEAU may cause serious side effects that can be life threatening as fallows:

• Problems swallowing, speaking, or breathing.

Spread of toxin effects:

• loss of strength and muscle weakness all over the body
• blurred vision and drooping eyelids
• trouble saying words clearlyo
• trouble breathing
• double vision
• hoarseness or change or loss of voice
• loss of bladder control
• trouble swallowing

What special precautions should I follow?

• swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech, or swallowing difficulties occur.
• Potential serious adverse reactions after JEUVEAU injections for unapproved uses.
• Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease.
• Use with caution in patients with compromised respiratory function or dysphagia.
• JEUVEAU may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving JEUVEAU. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

What to do in case of emergency/overdose?

• Excessive doses of JEUVEAU (prabotulinumtoxinA-xvfs) injection may be expected to produce neuromuscular weakness with a variety of symptoms.
• Symptoms of overdose are likely not to be present immediately following injection.
• Should accidental injection or oral ingestion occur, or overdose be suspected, these patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization.
• The person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local or distant from the site of injection.
• If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia.
• If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.

Management for overdosage

• In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.
• If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

Can this medicine be used in pregnancy?

• The limited available data on JEUVEAU use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: botulinum toxin type A
• Inactive ingredients: human serum albumin and sodium chloride

Who manufactures and distributes this medicine?

• Manufactured by: Evolus Inc., 520 Newport Center Drive, Suite 1200, Newport Beach, CA 92660

What should I know about storage and disposal of this medication?

• Unopened vials of JEUVEAU should be stored in a refrigerator between 2° to 8°C (36° to 46° F) in the original carton to protect from light.

Also see

• Botulinum_toxin

• Dailymed label info on PrabotulinumtoxinA-xvfs
• FDA PrabotulinumtoxinA-xvfs

PrabotulinumtoxinA-xvfs Resources
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