Daxxify

— THERAPEUTIC CATEGORIES —
  • Aesthetic medicine
  • Muscle spasms

Daxxify Generic Name & Formulations

General Description

DaxibotulinumtoxinA-lanm 50 Units, 100 Units; per vial; lyophilizied pwd for IM inj after reconstitution; preservative-free.

Pharmacological Class

Neuromuscular blocker.

How Supplied

Single-dose vial—1

Generic Availability

NO

Daxxify Indications

Indications

Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

Daxxify Dosage and Administration

Adult

See full labeling. Should be administered and managed by experienced physicians. Give by IM inj only. ≥18yrs: give 8 Units (0.1mL) into each of the 5 sites (2 injections in each corrugator muscles, and 1 injection in the procerus muscle). Max total dose: 40 Units per treatment session. Do not administer more frequently than every 3 months.

Children

<18yrs: not established.

Daxxify Contraindications

Contraindications

Infection at the proposed injection sites.

Daxxify Boxed Warnings

Boxed Warning

Distant spread of toxin effect.

Daxxify Warnings/Precautions

Warnings/Precautions

Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity); see full labeling. Increased risk for serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing cardiovascular disease, dysphagia, or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. In treating glabellar lines: presence of surgical alterations to the facial anatomy, marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, inflammation at inj sites, ptosis, excessive weakness or atrophy in the target muscles; consider ophthalmologist referral if dry eye symptoms persist. Pregnancy. Nursing mothers.

Daxxify Pharmacokinetics

See Literature

Daxxify Interactions

Interactions

May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May be potentiated by anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants. 

Daxxify Adverse Reactions

Adverse Reactions

Glabellar lines: headache, eyelid ptosis, facial paresis. Cervical dystonia: headache, inj site pain/erythema, muscular weakness, upper respiratory tract infection, musculoskeletal pain. All: hypersensitivity reactions (discontinue if occur), cardiovascular adverse reactions, dysphagia, breathing difficulties.

Daxxify Clinical Trials

See Literature

Daxxify Note

Not Applicable

Daxxify Patient Counseling

See Literature

Daxxify Generic Name & Formulations

General Description

DaxibotulinumtoxinA-lanm 50 Units, 100 Units; per vial; lyophilizied pwd for IM inj after reconstitution; preservative-free.

Pharmacological Class

Neuromuscular blocker.

How Supplied

Single-dose vial—1

Generic Availability

NO

Daxxify Indications

Indications

Cervical dystonia in adults.

Daxxify Dosage and Administration

Adult

See full labeling. Give by IM inj only. Individualize. ≥18yrs: usual range 125–250 Units per single treatment, given as a divided dose among affected muscles. Adjust dose in 50–75 Unit increments based on response.

Children

<18yrs: not established.

Daxxify Contraindications

Contraindications

Infection at the proposed injection sites.

Daxxify Boxed Warnings

Boxed Warning

Distant spread of toxin effect.

Daxxify Warnings/Precautions

Warnings/Precautions

Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity); see full labeling. Increased risk for serious adverse reactions (including excessive weakness, dysphagia, aspiration pneumonia) with unapproved use. Pre-existing cardiovascular disease, dysphagia, or breathing difficulties. Neuromuscular disorders (eg, ALS, myasthenia gravis, Lambert-Eaton syndrome); monitor closely. Compromised respiratory status; monitor. In treating glabellar lines: presence of surgical alterations to the facial anatomy, marked facial asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, inflammation at inj sites, ptosis, excessive weakness or atrophy in the target muscles; consider ophthalmologist referral if dry eye symptoms persist. Pregnancy. Nursing mothers.

Daxxify Pharmacokinetics

See Literature

Daxxify Interactions

Interactions

May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May be potentiated by anticholinergic drugs, botulinum neurotoxin products, and muscle relaxants. 

Daxxify Adverse Reactions

Adverse Reactions

Glabellar lines: headache, eyelid ptosis, facial paresis. Cervical dystonia: headache, inj site pain/erythema, muscular weakness, upper respiratory tract infection, musculoskeletal pain. All: hypersensitivity reactions (discontinue if occur), cardiovascular adverse reactions, dysphagia, breathing difficulties.

Daxxify Clinical Trials

See Literature

Daxxify Note

Not Applicable

Daxxify Patient Counseling

See Literature

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