Version May 2024
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.
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.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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:
Gastrointestinal: Dysphagia
Respiratory: Dyspnea
<1%, postmarketing, and/or case reports: Antibody development
Hypersensitivity to botulinum toxin or any component of the formulation
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.
Disease-related concerns:
• Neuromuscular disease: Avoid use in patients with myasthenia gravis (AAN [Narayanaswami 2021]). Use with caution in patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, 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.
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.
Other warnings/precautions:
• 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, Powder for Reconstitution, Intramuscular:
Jeuveau: PrabotulinumtoxinA-svfs 100 units (1ea)
No
Solution (reconstituted) (Jeuveau Intramuscular)
100 unit (per each): $732.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Generic: 100 units (1 ea)
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.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Jeuveau: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761085s000lbl.pdf#page=9
Glabellar lines: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: May enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Anticholinergic Agents: Botulinum Toxin-Containing Products may enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the neuromuscular-blocking effect of other Botulinum Toxin-Containing Products. Risk C: 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. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Botulinum Toxin-Containing Products may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies.
Because data related to the use of botulinum toxins for cosmetic procedures during pregnancy are limited, use is generally avoided (Garg 2022; Morgan 2006; Trivedi 2017)
It is not known if prabotulinumtoxinA is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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).
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.
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