Medically reviewed by Drugs.com. Last updated on Jun 19, 2019.
(pra BOT ue LYE num TOX in AY)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular [preservative free]:
Jeuveau: 100 units (1 ea) [contains albumin human]
- Neuromuscular Blocker Agent, Toxin
PrabotulinumtoxinA (botulinum toxin type A) is a neurotoxin, produced by Clostridium botulinum, spore-forming anaerobic bacillus, that 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, prabotulinumtoxinA 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 prabotulinumtoxinA.
Use: Labeled Indications
Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Hypersensitivity to botulinum toxin or any component of the formulation
Note: Consider the cumulative dose when treating patients with prabotulinumtoxinA if other botulinum toxin products have been used to treat other indications approved for those products.
Glabellar lines: IM: Inject 4 units (0.1 mL) into each of the 5 sites (2 injections in each corrugator muscle and 1 in mid-line of procerus muscle) for a total dose of 20 units (0.5 mL) per treatment session. Do not administer more frequently than every 3 months.
Refer to adult dosing.
Reconstitute each 100-unit vial with 2.5 mL sterile, preservative-free NS, to a final concentration of 4 units/0.1 mL and a total treatment dose of 20 units/0.5 mL. Slowly inject diluent into vial and gently mix; discard vial if vacuum does not pull diluent into vial. Administer within 24 hours after reconstitution.
IM: Use 30- to 33- gauge needle to administer intramuscularly. Inject into each of the 5 sites (2 injections in each corrugator muscle and 1 injection in the mid-line procerus muscle). Ensure injected volume/dose is accurate and where feasible keep to a minimum. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Lateral corrugator injections should be ≥1 cm above the bony supraorbital ridge. Do not inject toxin closer than 1 cm above the central eyebrow. Refer to manufacturer's labeling for additional administration details.
Store unopened vials under refrigeration between 2°C to 8°C (36°F to 46° F) in the original carton to protect from light. After reconstitution, store vials in a refrigerator in the original carton, and use within 24 hours. Vials are for single use; discard any unused solution. Do not freeze reconstituted solution.
Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy
Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Monitor therapy
Muscle Relaxants (Centrally Acting): May enhance the adverse/toxic effect of Botulinum Toxin-Containing Products. Specifically, the risk for increased muscle weakness may be enhanced. Monitor therapy
Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
>10%: Central nervous system: Headache (12%)
1% to 10%:
Hematologic & oncologic: Leukocytosis (1%)
Ophthalmic: Blepharoptosis (2%)
Respiratory: Upper respiratory tract infection (3%)
Frequency not defined:
<1%, postmarketing, and/or case reports: Antibody development
ALERT: U.S. Boxed WarningDistant spread of toxin effect:
The effects of all botulinum toxin products, including prabotulinumtoxinA, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. PrabotulinumtoxinA is not approved for the treatment of spasticity or any conditions other than glabellar lines.
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Serious and/or immediate hypersensitivity reactions (eg, anaphylaxis, serum sickness, urticaria, soft tissue edema, dyspnea) have occurred. If a reaction occurs, discontinue and institute immediate treatment.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Cardiovascular events: Use with caution in patients with cardiovascular disease; arrhythmia and myocardial infarction (some fatal) have been reported following administration. Some of these patients had risk factors including preexisting cardiovascular disease.
• Dysphagia: Treatment can result in swallowing or breathing difficulties; may persist for several months, and require use of a feeding tube. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Risk factors include small neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae.
• Ophthalmic effects: Dry eye, reduced tear production, reduced blinking, and corneal disorders may occur with botulinum toxins; persistent symptoms may require ophthalmologic evaluation.
• Systemic toxicity: [US Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening, and there have been reports of death; other symptoms reported include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphonia, dysarthria, and urinary incontinence. These symptoms have been reported hours to weeks after injection. In unapproved uses, including upper limb spasticity in children, and in approved indications, symptoms consistent with the spread of toxin have been reported at doses comparable to or lower than the maximum recommended total dose. Immediate medical attention required if respiratory disorders, speech, or swallowing difficulties appear.
• Neuromuscular disease: Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis, Lambert-Eaton syndrome). Risk of adverse events including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise may be increased.
• Respiratory disease: Use extreme caution in patients with preexisting respiratory disease; treatment with botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Serious breathing difficulties, including respiratory failure, have been reported. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
• Albumin: Product contains albumin; albumin carries an extremely remote risk for transmission of viral diseases, Creutzfeldt-Jakob disease (CJD) and variant CJD (vCJD). No cases of transmission of viral diseases or CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
• Product interchangeability: Botulinum products (abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, prabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.
• Injection site: Use with caution if there is inflammation or excessive weakness or atrophy at the proposed injection site(s). Use with caution in patients who have marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or, the inability to substantially lessen glabellar lines by physically spreading them apart.
• Unapproved use: Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, including fatalities, have been reported in patients who have received injections for unapproved uses. In these cases, the reactions were not necessarily related to distant spread of toxin, but may have resulted from administration to the site of injection and/or adjacent structures; several patients had preexisting dysphagia or other significant disabilities.
Difficulty with swallowing, speaking, breathing, or muscle weakness or paralysis in areas other than the targeted area; ophthalmic effects (eg, eye dryness, eye irritation, photophobia, or changes in vision).
Adverse events were not observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache or common cold symptoms. Have patient report immediately to prescriber blurred vision, voice changes, drooping eyelids, body weakness, bladder incontinence, double vision, difficulty breathing, difficulty speaking, difficulty swallowing, decreased tearing, decreased blinking, eye irritation, sensitivity to bright lights, vision changes, chest pain, abnormal heartbeat, severe injection site irritation, dizziness, passing out, muscle weakness, or signs of skin infection (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.