PrabotulinumtoxinA

PrabotulinumtoxinA is a prescription medication used for temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity.

• PrabotulinumtoxinA is available under the following different brand names: Jeuveau, prabotulinumtoxinA-xvfs

Common side effects of PrabotulinumtoxinA include:

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

Serious side effects of PrabotulinumtoxinA include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• wheezing
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication)
• trouble breathing
• difficulty talking
• trouble swallowing
• loss of bladder control
• hoarse voice
• drooping eyelids
• vision changes
• eye pain
• severely dry eyes
• irritated eyes
• sensitivity to light
• chest pain or pressure
• pain spreading to the jaw or shoulder
• irregular heartbeats

Rare side effects of PrabotulinumtoxinA include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, powder for reconstitution

• 100 units/single-dose vial

Glabellar Lines

Adult dosage

• 0.1 mL (4 units) IM each of 5 sites (i.e., interomedial and superior middle of each corrugator muscle and 1 injection midline of the procerus muscle) for a total dose of 20 units
• Re-treat no sooner than every 3 months

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• PrabotulinumtoxinA has severe interactions with no other drugs
• PrabotulinumtoxinA has serious interactions with the following drugs:
  • abobotulinumtoxinA
  • incobotulinumtoxinA
  • onabotulinumtoxinA
• PrabotulinumtoxinA has moderate interactions with at least 32 other drugs
• PrabotulinumtoxinA has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to any botulinum toxin preparation or any of the components in the formulation
• Presence of infection at the proposed injection site(s)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using PrabotulinumtoxinA?”

Long-Term Effects

• See “What Are Side Effects Associated with Using PrabotulinumtoxinA?”

Cautions

• Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond the local injection site; not approved for spasticity or any conditions other than glabellar lines
• Not interchangeable with other preparations of botulinum toxin products and cannot be compared with nor converted into units of any other botulinum toxin products assessed with any other specific assay method
• Serious adverse reactions (eg, excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes) were reported in patients who received botulinum toxin injections for unapproved uses
• Serious and/or immediate hypersensitivity reactions reported
  • Cardiovascular adverse events (eg, arrhythmia, myocardial infarction), some with fatal outcomes, were reported following botulinum toxin administration
  • Patients with neuromuscular disorders may be at increased risk of clinically significant effects, including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from treatment
• Treatment can result in swallowing or breathing difficulties
  • Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
  • Use with caution in patients with compromised respiratory function or dysphagia
  • Deaths, as a complication of severe dysphagia, have been reported after treatment with botulinum toxin
  • Caution if inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s)
  • Caution in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin or subjects who may not respond to 20 units of botulinum toxin, (e.g., inability to substantially lessen glabellar lines even by physically spreading them apart)
  • Dry eye reported; reduced tear production, reduced blinking, and corneal disorders may occur
  • The product contains albumin; based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for viral transmission of variant Creutzfeldt-Jakob disease (vCJD)
  • Caution if coadministered with aminoglycosides or other agents interfering with neuromuscular transmission (eg, anticholinergic drugs, other botulinum neurotoxin products, muscle relaxants); it may potentiate prabotulinumtoxinA effect

Pregnancy and Lactation

• Limited available data on drug use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
• An embryofetal developmental study conducted in pregnant rats revealed no treatment-related effects on the developing fetus when administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (MRHD)
• Lactation
  • There is no information regarding the presence of prabotulinumtoxinA in human or animal milk, its effects on the breastfed infant, or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition