(rime uh BOT yoo lin num TOKS in bee)
- Botulinum Toxin Type B
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intramuscular [preservative free]:
Myobloc: 2500 units/0.5 mL (0.5 mL); 5000 units/mL (1 mL); 10,000 units/2 mL (2 mL) [contains albumin human]
Brand Names: U.S.
- Neuromuscular Blocker Agent, Toxin
RimabotulinumtoxinB (previously known as botulinum toxin type B) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus. It cleaves synaptic Vesicle Association Membrane Protein (VAMP; synaptobrevin) which is a component of the protein complex responsible for docking and fusion of the synaptic vesicle to the presynaptic membrane. By blocking neurotransmitter release, rimabotulinumtoxinB paralyzes the muscle.
Not expected to be present in peripheral blood at recommended doses
Duration of Action
Use: Labeled Indications
Treatment of cervical dystonia (spasmodic torticollis)
Treatment of cervical dystonia in patients who have developed resistance to onabotulinumtoxinA or abobotulinumtoxinA
Hypersensitivity to botulinum toxin or any component of the formulation; infection at the injection site(s)
Cervical dystonia: IM: Initial: 2500-5000 units divided among the affected muscles in patients previously treated with botulinum toxin; initial dose in previously untreated patients should be lower. Subsequent dosing should be optimized according to patient's response.
Refer to adult dosing.
Not established in pediatric patients
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling.
May be diluted with normal saline. Do not shake.
Do not mix with any other medicines.
Store vials under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 21 months. Protect from light. Once diluted, use within 4 hours. Does not contain preservative. Single use vial. Do not freeze.
AbobotulinumtoxinA: May enhance the adverse neuromuscular effect of RimabotulinumtoxinB. Monitor therapy
Aminoglycosides: May enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Monitor therapy
Anticholinergic Agents: May enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Neuromuscular-Blocking Agents: May enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Monitor therapy
OnabotulinumtoxinA: May enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Monitor therapy
Central nervous system: Headache (10% to 16%), pain (≤13%)
Gastrointestinal: Dysphagia (10% to 25%; severe dysphagia: 3%), xerostomia (3% to 34%; severe xerostomia: 6%)
Local: Injection site pain (12% to 16%)
Neuromuscular & skeletal: Neck pain (≤17%)
Miscellaneous: Infection (≤19%), antibody formation (~10% to 18%, at 12 and 18 months, respectively)
1% to 10%:
Cardiovascular: Chest pain, edema, peripheral edema, vasolidation
Central nervous system: Dizziness (3% to 6%), anxiety, chills, confusion, fever, hyperesthesia, malaise, migraine, somnolence, tremor, vertigo
Dermatologic: Pruritus, bruising
Endocrine & metabolic: Hypercholesterolemia
Gastrointestinal: Nausea (≤10%), dyspepsia (≤10%,) glossitis, stomatitis, taste perversion, vomiting
Genitourinary: Cystitis, urinary tract infection, vaginal moniliasis
Hematologic: Serum neutralizing activity
Neuromuscular & skeletal: Torticollis (≤8%), arthralgia (≤7%), back pain (≤7%), myasthenia (≤6%), weakness (≤6%), arthritis, hernia
Ocular: Amblyopia, vision abnormal
Otic: Otitis media, tinnitus
Respiratory: Cough (3% to 7%; placebo 3%), dyspnea, pneumonia
Miscellaneous: Flu-like syndrome (6% to 9%), abscess, allergic reaction, cyst, neoplasm, viral infection
<1% (Limited to important or life-threatening): Constipation
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions may occur; immediate treatment (including epinephrine 1 mg/mL) should be available.
• Antibody formation: Higher doses or more frequent administration may result in neutralizing antibody formation and loss of efficacy.
• Cardiovascular events: Rarely, arrhythmia and myocardial infarction have been reported with use of onabotulinumtoxinA (another botulinum toxin formulation), sometimes in patients with preexisting cardiovascular disease.
• Dysphagia: Common when used for cervical dystonia and may persist anywhere from 2 weeks up to 5 months after administration. In severe cases, patients may require alternative feeding methods. Risk factors include smaller neck muscle mass, bilateral injections into the sternocleidomastoid muscle, or injections into the levator scapulae.
• Systemic toxicity: [U.S. Boxed Warning]: Distant spread of botulinum toxin beyond the site of injection has been reported; dysphagia and breathing difficulties have occurred and may be life threatening; other symptoms reported include blurred vision, diplopia, dysarthria, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence which may develop within hours or weeks following injection. Risk likely greatest in children treated for the unapproved use of spasticity. Systemic effects have occurred following use in approved and unapproved uses, including low doses. Immediate medical attention required if respiratory, speech, or swallowing difficulties appear
• Neuromuscular disease: Use with caution in patients with neuromuscular diseases (eg, myasthenia gravis, Eaton-Lambert syndrome) and neuropathic disorders (eg, amyotrophic lateral sclerosis).
• Respiratory disease: Use extreme caution in patients with pre-existing respiratory disease; treatment of cervical dystonia using botulinum toxin may weaken accessory muscles that are necessary for these patients to maintain adequate ventilation. Risk of aspiration resulting from severe dysphagia is increased in patients with decreased respiratory function.
Concurrent drug therapy issues:
• Neuromuscular transmission: Use with extreme caution in patients receiving other agents that may interfere with neuromuscular transmission (eg, aminoglycosides, neuromuscular-blocking agents)
Dosage form specific issues:
• Albumin: Product contains albumin and may carry a remote risk of virus transmission.
• Product interchangeability: Botulinum products (abobotulinumtoxinA, onabotulinumtoxinA, rimabotulinumtoxinB) are not interchangeable; potency units are specific to each preparation and cannot be compared or converted to any other botulinum product.
• Appropriate use: Concurrent use of onabotulinumtoxinA (or abobotulinumtoxinA) or use within <4 months of rimabotulinumtoxinB is not recommended.
• Chronic therapy: Long-term effects of chronic therapy unknown.
• Injection site: Use with caution if there is inflammation, excessive weakness, or atrophy at the proposed injection site(s).
Pregnancy Risk Factor
Reproduction studies have not been conducted. Based on limited case reports using onabotulinumtoxinA, adverse fetal effects have not been observed with inadvertent administration during pregnancy. It is currently recommended to ensure adequate contraception in women of childbearing years.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience injection site irritation, headache, dry mouth, or neck pain. Have patient report immediately to prescriber signs of infection, blurred vision, change in voice, droopy eyelids, loss of strength and energy, difficulty breathing, dysphagia, difficulty speaking, severe muscle pain, severe muscle weakness, sudden vision changes, eye pain, eye irritation, urinary incontinence, or diplopia (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about botulinum toxin type b
- Other brands: Myobloc