prabotulinumtoxinA (Rx)

Brand and Other Names:Jeuveau, prabotulinumtoxinA-xvfs
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and prabotulinumtoxinA

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            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)

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                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

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                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

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                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.

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                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

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                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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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

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                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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                NC NOT COVERED – Drugs that are not covered by the plan.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.