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.

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.

Availability ⬆ ⬇

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

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.

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: cosmetic agents

Pharmacologic Classification: neurotoxins

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

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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Indications ⬇