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Myobloc Generic Name & Formulations
Legal Class
Rx
General Description
RimabotulinumtoxinB 2500 Units/0.5mL, 5000 Units/1mL, 10000 Units/2mL; soln for IM or intraglandular inj; contains human albumin; preservative-free.
Pharmacological Class
Neuromuscular blocker.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Myobloc Indications
Indications
Cervical dystonia, to reduce severity of abnormal head position and neck pain. Chronic sialorrhea.
Myobloc Dosage and Administration
Adult
Should be administered and managed by experienced physicians. Individualize. Cervical dystonia (treatment-experienced): initially 2500–5000 Units divided among affected muscles; (treatment-naïve): use lower initial dose. Sialorrhea: 1500–3500 Units divided among the parotid (500–1500 Units/gland) and submandibular (250 Units/gland) glands. May repeat treatments no sooner than every 12 weeks. Both: adjust subsequent doses based on response.
Children
Not established.
Myobloc Contraindications
Contraindications
Infection at proposed inj site.
Myobloc Boxed Warnings
Boxed Warning
Distant spread of toxin effect.
Myobloc 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. Pre-existing dysphagia or breathing difficulties. Neuromuscular disorders (eg, myasthenia gravis, ALS, Lambert-Eaton syndrome); monitor closely. Compromised respiratory function; monitor. Contains human albumin; monitor for possible viral disease or Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.
Myobloc Pharmacokinetics
See Literature
Myobloc Interactions
Interactions
May be potentiated by aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds). May potentiate anticholinergic effects with concomitant anticholinergic drugs. Concomitant other botulinum toxin products or muscle relaxants may potentiate neuromuscular weakness.
Myobloc Adverse Reactions
Adverse Reactions
Dry mouth, dysphagia (may be severe), inj site pain, headache; hypersensitivity reactions (discontinue if occur), possible antibody formation.
Myobloc Clinical Trials
See Literature
Myobloc Note
Not Applicable
Myobloc Patient Counseling
See Literature
