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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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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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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            Formulary

            FormularyPatient Discounts

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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.
            5 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.
            Code Definition
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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.