daxibotulinumtoxina

REMS

Temporary improvement in the appearance of moderate to severe glabellar lines (brow furrow) associated with corrugator and/or procerus muscle activity.
Cervical dystonia.

Action ⬆ ⬇

Produces partial chemical denervation by inhibiting the release of acetylcholine. Result is local decrease in muscle activity.

Therapeutic effects:

Decreased brow furrow with improved appearance
Decreased severity of abnormal head position and neck pain.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal systemic absorption; action is primarily local.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
IM	<2 wk	unknown	3–4 mo

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Presence of infection at planned injection sites.

Use Cautiously in:

Peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome) or pre-existing swallowing or breathing difficulties (↑ risk of significant systemic effects such as dysphagia or respiratory compromise);
Inflammation at planned injection site, marked facial asymmetry, eyelid/eyebrow ptosis, excessive dermatochelasis, deep dermal scarring, thick sebaceous skin, inability to lessen glabellar lines by physical spreading;
Cardiovascular disease;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

EENT: dry eye, temporary eyelid droop

GI: dysphagia

Local: distant spread of toxin effect, injection sites reactions

MS: facial asymmetry, facial paresis

Neuro: headache

Resp: dyspnea

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Neuromuscular effects may be potentiated by aminoglycosides, anticholinergic drugs, muscle relaxants, or other forms of botulinum toxin.

Route/Dosage ⬆ ⬇

Not interchangeable with other botulinum toxin products.

Reduction of Moderate to Severe Glabellar Lines

IM (Adults ): 8 units into each of five sites (two in each corrugator muscle and one in the procerus muscle); should not be administered more frequently than every 3 mo.

Cervical Dystonia

IM (Adults ): 125–250 units divided among the affected muscles; if patient previously treated with another botulinum toxin, the past dose, response to treatment, duration of effect, and adverse event history should be considered when determining the initial dose. Not to be administered more frequently than every 3 mo.

Availability ⬆ ⬇

Powder for injection: 50 units/vial ; 100 units/vial

Assessment ⬆ ⬇

Assess for therapeutic and adverse effects; occur typically ≤14 days and up to 3 mo after injection.
Monitor for signs of hypersensitivity reaction.If dyspnea, serum sickness, urticaria, or angioedema occur,immediately stop injections and provide appropriate medical care. Keep resuscitation equipment and pharmacologic agents nearby.
Monitor for signs of the spread of toxin effects (asthenia, general muscle weakness, diplopia, ptosis, dysphagia, dysphonia, urinary incontinence, dyspnea). Pre-existing motor neuropathic or neuromuscular disorders ↑ risk of generalized muscle weakness.If difficulties with swallowing, speech, or respiration occur,immediately stop injections and provide appropriate medical care.
Assess for pre-existing cardiovascular disease prior to administration. Use has been associated with arrhythmia and myocardial infarction.
Assess planned injection sites and underlying muscles for surgical alterations, scarring, facial asymmetry, inflammation, excessive weakness, or atrophy prior to administration.

Implementation ⬆ ⬇

Clinicians administering daxibotulinumtoxinA should understand neuromuscular anatomy of the area involved.
- Botulinum toxin products are not interchangeable. Determine appropriate product prior to administration.
- Injections should be made no more frequently than every 3 mo and using the lowest effective dose.
Reconstitution: Reconstitute vial with 0.9% NaCl without preservatives. 50 unit vial: Gently inject 0.6 mL diluent. 100 unit vial: Gently inject 1.2 mL diluent for glabellar line treatment; gently inject 1 mL or 2 mL for cervical dystonia treatment. Reconstituted solution is clear, opalescent, colorless, and free of particulates. Do not freeze. Refrigerate, protect from light, and administer within 72 hr of reconstitution.
IM: Follow specific concentration, dose, and administration recommendations for each indication according to the drug label. Only use reconstituted solution for one injection session and one patient. Discard any remaining solution after administration.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Inform patient that the toxin effect may spread from the injection site. Symptoms may occur hrs to wks after injection. Advise patient to notify health care professional immediately if swallowing, speech, or respiratory difficulties arise.
May cause muscle weakness, blurred vision, or drooping eyelids. Caution patient to avoid driving or other activities requiring alertness and dexterity until response to injection is known.
Advise patient to contact ophthalmologist for persistent symptoms of dry eye.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇