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Xeomin Generic Name & Formulations
Legal Class
Rx
General Description
IncobotulinumtoxinA 50 Units, 100 Units, 200 Units; per vial; lyophilized pwd for IM or intra-salivary gland inj after reconstitution; contains human albumin, sucrose; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Xeomin blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine.
Xeomin Indications
Indications
Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity.
Xeomin Dosage and Administration
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.
Xeomin Contraindications
Contraindications
Infection at proposed injection site.
Xeomin Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Xeomin Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity, adults with underlying conditions); see full labeling. Pre-existing dysphagia or breathing difficulties, conditions at the inj site (eg, excessive weakness or atrophy). 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 or Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Xeomin Pharmacokinetics
See Literature
Xeomin Interactions
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.
Xeomin Adverse Reactions
Adverse Reactions
Chronic sialorrhea: tooth extraction, dry mouth, diarrhea, hypertension, bronchitis, headache, nausea/vomiting. Upper limb spasticity: seizure, nasopharyngitis, dry mouth, upper respiratory tract infection, bronchitis. 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; corneal exposure/ulceration, ectropion (avoid inj into lower lid area). Glabellar lines: headache; ptosis. All: hypersensitivity reactions (discontinue if occur), possible antibody formation.
Xeomin Clinical Trials
See Literature
Xeomin Note
Not Applicable
Xeomin Patient Counseling
See Literature
Xeomin Generic Name & Formulations
Legal Class
Rx
General Description
IncobotulinumtoxinA 50 Units, 100 Units, 200 Units; per vial; lyophilized pwd for IM or intra-salivary gland inj after reconstitution; contains human albumin, sucrose; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Xeomin blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine.
Xeomin Indications
Indications
Chronic sialorrhea in patients ≥2yrs. Upper limb spasticity in adults. Upper limb spasticity in children 2–17yrs, excluding cerebral palsy. Cervical dystonia. Blepharospasm.
Xeomin Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Use needle electromyographic guidance, nerve stimulation, or ultrasound for localization of the involved muscles. Max cumulative dose: 400 Units in a treatment session. ≥18yrs: Individualize; see full labeling. Chronic sialorrhea: inject 30 Units per side of the parotid gland and 20 Units per side of the submandibular gland (4 total inj sites); total dose: 100 Units per treatment session. 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 (treatment-naive): initial total dose: 50 Units (25 Units/eye); (previously-treated): consider dose, response, duration of effect, adverse reactions from previous botulinum toxin A treatment to determine dose. Max 100 Units per treatment session (50 Units/eye). For all: dose, frequency, and number of inj sites should be based on the size, number and location of muscles to be treated, severity, presence of muscle weakness, response to previous treatment, and adverse event history. May repeat treatments no sooner than every 12 weeks (16 weeks for chronic sialorrhea).
Children
Cervical dystonia, blepharospasm: <18yrs: not established. Chronic sialorrhea (<12kg: not studied), upper limb spasticity: <2yrs: not established. Use needle electromyographic guidance, nerve stimulation, or ultrasound for localization of the involved muscles. Max cumulative dose: 400 Units in a treatment session. Individualize; see full labeling. Chronic sialorrhea: ≥2yrs (≥12kg): divide body-weight adjusted dose with a ratio of 3:2 injected into each parotid and submandibular glands, respectively (see full labeling). Upper limb spasticity: 2–17yrs: max 8 Units/kg divided among affected muscles (see full labeling); up to max 200 Units/single upper limb. Treating both upper limbs: total max 16 Units/kg, up to max 400 Units. May repeat treatments no sooner than every 12 weeks (16 weeks for chronic sialorrhea).
Xeomin Contraindications
Contraindications
Infection at proposed injection site.
Xeomin Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Xeomin Warnings/Precautions
Warnings/Precautions
Not interchangeable with other botulinum toxin products. Risk of distant spread of toxin effect (esp. in children treated for spasticity, adults with underlying conditions); see full labeling. Pre-existing dysphagia or breathing difficulties, conditions at the inj site (eg, excessive weakness or atrophy). 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 or Creutzfeldt-Jakob disease transmission. Elderly. Pregnancy. Nursing mothers.
Xeomin Pharmacokinetics
See Literature
Xeomin Interactions
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.
Xeomin Adverse Reactions
Adverse Reactions
Chronic sialorrhea: tooth extraction, dry mouth, diarrhea, hypertension, bronchitis, headache, nausea/vomiting. Upper limb spasticity: seizure, nasopharyngitis, dry mouth, upper respiratory tract infection, bronchitis. 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; corneal exposure/ulceration, ectropion (avoid inj into lower lid area). Glabellar lines: headache; ptosis. All: hypersensitivity reactions (discontinue if occur), possible antibody formation.
Xeomin Clinical Trials
See Literature
Xeomin Note
Not Applicable
Xeomin Patient Counseling
See Literature
