daxibotulinumtoxinA (Rx)

Brand and Other Names:Daxxify, daxibotulinumtoxinA-lanm

Dosing & Uses

AdultPediatric

injection, lyophilized powder for reconstitution

  • 50 units/single-dose vial
  • 100 units/single-dose vial

Glabellar Lines

Indicated for temporary improvement in appearance of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity

8 units IM each into 5 sites, for a total dose of 40 units

2 injections in each corrugator muscle and 1 injection in procerus muscle

Administer no more frequently than every 3 months

Cervical Dystonia

Indicated for cervical dystonia in adults

125-250 units IM divided among affected muscles

Limiting dose injected into the sternocleidomastoid muscle may reduce dysphagia occurrence

In patients previously treated with another botulinum toxin, their past dose, response to treatment, duration of effect, and adverse event history should be taken into consideration when determining the initial daxibotulinumtoxinA dose

Dosage Modifications

Cervical dystonia

  • When dose modification is necessary, dose adjustment can be made in 50-75 unit increments according to individual response

Dosing Considerations

Not interchangeable with other botulinum toxin products

Units of biological activity of daxibotulinumtoxinA are not comparable or convertible to units of any other botulinum toxin products assessed with any other specific test method

Consider cumulative dose when treating patients; be aware of patients who are receiving treatment with other botulinum toxin products for other indications

Safety and efficacy not established

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Interactions

Interaction Checker

and daxibotulinumtoxinA

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (2)

                • sodium sulfate/?magnesium sulfate/potassium chloride

                  sodium sulfate/?magnesium sulfate/potassium chloride increases effects of daxibotulinumtoxinA 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 daxibotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.

                Minor (0)

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                  Adverse Effects

                  1-10%

                  Headache (5-6%)

                  Injection site reactions (6%)

                  Injection site pain (4%)

                  Injection site erythema (3%)

                  Injection site edema (3%)

                  Injection site bruising (1%)

                  Eyelid ptosis (1-2%)

                  Edema (2%)

                  Erythema (2%)

                  Facial paresis (1%)

                  <1%

                  Injection site papule (<1%)

                  Injection site pruritus (<1%)

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                  Warnings

                  Black Box Warnings

                  Distant spread of toxin effect

                  • Effects may spread from injection area 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
                  • Risk is probably greatest in children treated for spasticity, an unapproved use for daxibotulinumtoxinA, but symptoms can also occur in adults, particularly in those patients who have an underlying condition that would predispose them to these symptoms

                  Contraindications

                  Hypersensitivity to any botulinum toxin preparation, daxibotulinumtoxinA or its excipients

                  Presence of infection at proposed injection sites

                  Cautions

                  Not interchangeable with other botulinum toxin products

                  Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received botulinum toxin injections for unapproved uses

                  Serious and/or immediate hypersensitivity reactions have been reported for botulinum toxin products; reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea; if such a reaction occurs, discontinue further injection, and immediately institute appropriate medical therapy

                  Adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes have been reported for botulinum toxin products; use caution when administering to patients with pre-existing cardiovascular disease

                  Monitor with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) for increased neuromuscular compromise following botulinum toxin treatment; 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 administration

                  Use caution when administering to patients with surgical alterations to the facial anatomy, marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, inflammation at injection site(s), pre-existing eyelid, or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, or the inability to substantially lessen glabellar lines even by physically spreading them apart

                  Reduced tear production, reduced blinking, and corneal disorders may occur with use of botulinum toxins, including daxibotulinumtoxinA; dry eye has been reported with the use of botulinum toxin products in the treatment of glabellar lines; if symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patient to an ophthalmologist

                  Spread of Toxin Effect

                  • Postmarketing safety data from other approved botulinum toxins suggest that botulinum toxin effects may be observed beyond local injection site
                  • Symptoms include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
                  • Risk of symptoms is greatest in children treated for spasticity, but symptoms can occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these

                  Dysphagia and breathing difficulties

                  • Treatment may result in swallowing or breathing difficulties
                  • These reactions can occur within hours to weeks after injection with botulinum toxin
                  • Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications
                  • May be a consequence of weakening of muscles in injection area that are involved in breathing or swallowing
                  • Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin products
                  • When distant effects occur, additional respiratory mechanisms may be involved
                  • Patients with respiratory disorders who may have become dependent upon accessory muscles may experience critical loss of breathing capacity
                  • If problems with swallowing, speech or respiratory disorders develop, immediately seek medical attention

                  Drug interaction overview

                  • No formal drug interaction studies conducted
                  • Use with caution owing to potential risk with the following
                    • Aminoglycosides or other agents interfering with neuromuscular transmission
                    • Anticholinergic drugs
                    • Botulinum neurotoxin products
                    • Muscle relaxants
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                  Pregnancy & Lactation

                  Pregnancy

                  No available data are available on use in pregnant female to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

                  Animal data

                  • IM administration during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40x the maximum recommended human dose

                  Lactation

                  There are no data on presence in human or animal milk, effects on the breastfed infant, or effects on milk production

                  Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant 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

                  Blocks cholinergic transmission at neuromuscular junction by inhibiting the release of acetylcholine

                  When injected into skeletal muscle, drug is internalized into nerve terminal, translocates into the neuronal cytosol where it cleaves SNAP25, a protein necessary for synaptic vesicle membrane docking and subsequent release of acetylcholine which produces a dose dependent decrease of muscle function

                  Recovery of activity is gradual and results from the degradation of neurotoxin light chain in the neurons with a contribution from the formation of axonal sprouts

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                  Administration

                  IM Preparation

                  Reconstitution

                  • Slowly inject diluent into vial, discard of any unused diluent
                  • Discard vial if a vacuum does not pull diluent into vial
                  • Gently mix by rotating vial
                  • Glabellar lines
                    • 50-unit vial: Reconstitute with 0.6 mL of preservative-free 0.9% NaCl
                    • 100-unit vial: Reconstitute with 1.2 mL of preservative-free 0.9% NaCl
                    • Resulting concentration is 8 units/ 0.1 mL for either dilution
                  • Cervical dystonia
                    • Use 100-unit vial(s) reconstituted with preservative-free 0.9% NaCl
                    • Reconstituted with 1 mL: Resulting concentration is 10 units/0.1 mL
                    • Reconstitute with 2 mL: Resulting concentration is 5 units/0.1 mL

                  IM Administration

                  Reconstituted solutions are for IM administration only

                  Administer within 72 hr after reconstitution

                  Inspect visually the reconstituted solution for particulate matter and discoloration prior to administration; discard if solution is cloudy or discolored or contains flakes or particles

                  Use each reconstituted vial for only 1 injection session and for only 1 patient; discard any remaining solution in vial immediately after administering

                  Glabellar lines

                  • Carefully examine upper eyelid margin position for separation or weakness of levator palpebrae superioris muscle; evaluate range of upper eyelid excursion while manually immobilizing the frontalis
                  • Clean vial stopper with an alcohol swab
                  • Draw up aseptically at least 0.5 mL of reconstituted solution with a sterile syringe, preferably a tuberculin syringe, and expel any air bubbles
                  • Remove needle and attach a 30–33-gauge needle; confirm patency of needle
                  • Advance needle through skin into underlying muscle while applying finger pressure on superior medial orbital rim
                  • Inject 8 units (0.1 mL) into each of 5 injection sites: 2 injections into medial corrugator and lateral corrugator muscles respectively, and 1 injection in the procerus muscle
                  • To reduce complication of ptosis, follow these steps
                    • Avoid injection near levator palpebrae superioris, particularly in patients with larger brow depressor complexes
                    • Ensure injected volume/dose is accurate and administer in a steady controlled manner
                    • Do not inject drug <1 cm above superior orbital rim

                  Storage

                  Unopened vials

                  • Store at room temperature 20-25ºC (68-77ºF) or refrigerate at 2-8ºC (36-46ºF)

                  Diluted vials

                  • Refrigerate at 2-8ºC (36-46ºF) for up to 72 hr
                  • Protect from light
                  • Do not freeze
                  • Discard of any unused drug
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                  Images

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                  Patient Handout

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

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  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.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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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.