Daxxify Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial—1
Manufacturer
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
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial—1
Manufacturer
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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