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XEOMIN
Aesthetic medicine
Muscle spasms
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Drug Name:

XEOMIN Rx

Generic Name and Formulations:
IncobotulinumtoxinA 50 Units, 100 Units, 200 Units; per vial; lyophilized pwd; for IM inj after reconstitution and dilution; contains human albumin; preservative-free.

Company:
Merz Pharmaceuticals

Therapeutic Use:

Indications for XEOMIN:

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

Adult:

Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a treatment session. ≥18yrs: Initial total dose: 20 Units per treatment session divided into 5 equal injections of 4 Units each (2 injections in each corrugator muscle and 1 injection in the procerus muscle). May repeat treatments no sooner than every 12 weeks.

Children:

<18yrs: not established.

Contraindications:

Infection at proposed injection site.

Warnings/Precautions:

Not interchangeable with other botulinum toxin products. Pre-existing dysphagia or breathing difficulties. Patients with smaller neck muscle mass or those who require bilateral inj into the sternocleidomastoid muscles: increased risk of dysphagia. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Compromised respiratory function; monitor. Narrow angle glaucoma. Contains human albumin; monitor for possible viral disease transmission. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions:

May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, tubocurarine-type muscle relaxants). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

Upper limb spasticity: seizure, nasopharyngitis, dry mouth, upper respiratory tract infection; Cervical dystonia: dysphagia (may be severe), neck pain, muscle weakness, inj site reactions, musculoskeletal pain; blepharospasm: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, respiratory tract infection; corneal exposure/ulceration, ectropion (avoid injection of lower lid area); glabellar lines: headache; all: respiratory failure, allergic reactions (discontinue if occurs), spread of toxin effect (may be fatal), possible antibody formation.

Generic Availability:

NO

How Supplied:

Single-use vial—1

Indications for XEOMIN:

Upper limb spasticity in adults. Cervical dystonia in both botulinum toxin-naïve and previously treated adult patients. Blepharospasm in adults previously treated with onabotulinumtoxinA.

Adult:

Should be administered and managed by experienced physicians. Max cumulative dose: 400 Units in a treatment session. ≥18yrs: Individualize; see full labeling. Upper limb spasticity (not previously treated): initially give dose at the low end of dosing range and titrate as needed. Cervical dystonia: initial total dose: 120 Units per treatment session. Blepharospasm: (previously-treated): use same dose as previous treatment of onabotulinumtoxinA; (previous-dose unknown): initially 1.25–2.5 Units/injection site. Both eyes: total initial dose: max 70 Units (35 Units/eye). For all: dose, number, and location of inj sites should be based on the size, number and location of muscles involved, severity, and response to any previous botulinum toxin inj. May repeat treatments no sooner than every 12 weeks.

Children:

<18yrs: not established.

Contraindications:

Infection at proposed injection site.

Warnings/Precautions:

Not interchangeable with other botulinum toxin products. Pre-existing dysphagia or breathing difficulties. Patients with smaller neck muscle mass or those who require bilateral inj into the sternocleidomastoid muscles: increased risk of dysphagia. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Compromised respiratory function; monitor. Narrow angle glaucoma. Contains human albumin; monitor for possible viral disease transmission. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions:

May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, tubocurarine-type muscle relaxants). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.

Pharmacological Class:

Neuromuscular blocker.

Adverse Reactions:

Upper limb spasticity: seizure, nasopharyngitis, dry mouth, upper respiratory tract infection; Cervical dystonia: dysphagia (may be severe), neck pain, muscle weakness, inj site reactions, musculoskeletal pain; blepharospasm: eyelid ptosis, dry eye, dry mouth, diarrhea, headache, visual impairment, dyspnea, nasopharyngitis, respiratory tract infection; corneal exposure/ulceration, ectropion (avoid injection of lower lid area); glabellar lines: headache; all: respiratory failure, allergic reactions (discontinue if occurs), spread of toxin effect (may be fatal), possible antibody formation.

Generic Availability:

NO

How Supplied:

Single-use vial—1

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