Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 100units/single-dose vial
Glabellar Lines
Indicated for temporary improvement in the appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity
0.1 mL (4 units) IM each of 5 sites (ie, 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 q3Months
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- abobotulinumtoxinA
abobotulinumtoxinA, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
prabotulinumtoxinA, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin. - incobotulinumtoxinA
prabotulinumtoxinA, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- onabotulinumtoxinA
onabotulinumtoxinA, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
Monitor Closely (32)
- amikacin
amikacin increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- amikacin liposome inhalation
amikacin liposome inhalation increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- arbaclofen
arbaclofen increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- atropine
atropine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- baclofen
baclofen increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- carisoprodol
carisoprodol increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- chlorzoxazone
chlorzoxazone increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- cyclobenzaprine
cyclobenzaprine increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dantrolene
dantrolene increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- darifenacin
darifenacin, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- diazepam
diazepam increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- dicyclomine
dicyclomine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- fesoterodine
fesoterodine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- gentamicin
gentamicin increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- glycopyrrolate
glycopyrrolate, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- hyoscyamine
hyoscyamine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- hyoscyamine spray
hyoscyamine spray, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- metaxalone
metaxalone increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- methocarbamol
methocarbamol increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- methscopolamine
methscopolamine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- neomycin PO
neomycin PO increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- orphenadrine
orphenadrine increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Muscle relaxants may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- plazomicin
plazomicin increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- propantheline
propantheline, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases effects of prabotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases effects of prabotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- solifenacin
solifenacin, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- streptomycin
streptomycin increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tobramycin
tobramycin increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tobramycin inhaled
tobramycin inhaled increases effects of prabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Aminoglycosides may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.
- tolterodine
tolterodine, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
- trospium chloride
trospium chloride, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.
Minor (0)
Adverse Effects
>10%
Headache (12%)
1-10%
Upper respiratory tract infection (3%)
Eyelid ptosis (2%)
Increased white blood cell count (1%)
Frequency Not Defined
Injection site: Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising
Needle-related pain and/or anxiety
Warnings
Black Box Warnings
Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects
Symptoms have been reported hours to weeks after injection and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
Swallowing and breathing difficulties can be life threatening, and deaths have been reported
PrabotulinumtoxinA is not approved for treatment of spasticity or any conditions other than glabellar lines
Contraindications
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
Presence of infection at the proposed injection site(s)
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) 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, 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, (eg, 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
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); may potentiate prabotulinumtoxinA effect
Pregnancy
Pregnancy
Limited available data on 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 to 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 on 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 from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Acetylcholine release inhibitor and a neuromuscular blocking agent blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering nerve terminals, and inhibiting acetylcholine release
When injected intramuscularly at therapeutic doses, prabotulinumtoxinA-xvfs produces partial chemical denervation of the muscle, resulting in a localized reduction in muscle activity
In addition, muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop
Administration
IM Preparation
Reconstitute each vial with sterile, preservative-free 0.9% NaCl to obtain a reconstituted solution of 4 units/0.1 mL
Slowly inject diluent into the vial
Discard vial if a vacuum does not pull the diluent into the vial
Dispose of any unused saline
Gently mix with 0.9% NaCl by rotating the vial
Reconstituted solution should be a clear, colorless solution, free of particulate
IM Administration
Avoid injection near levator palpebrae superioris, particularly in patients with larger brow depressor complexes
Place lateral corrugator injections at least 1 cm above the bony supraorbital ridge
Avoid injecting toxin closer than 1 cm above the central eyebrow
Draw at least 0.5 mL of the properly reconstituted toxin into a sterile syringe and expel any air bubbles in the syringe barrel
Inject 0.1 mL (4 units) IM into each of 5 sites (ie, inferomedial and superior middle of each corrugator and one in the mid-line of the procerus muscle) for a total dose of 20 units
Storage
Unopened vials: Refrigerate at 2-8°C (36-46°F) in the original carton to protect from light
Reconstituted vials: Refrigerate at 2-8°C (36-46°F) for up to 24 hr
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