Dosing & Uses
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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

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)
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%)
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
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.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
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
Images
Formulary
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