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Rimabotolinumtoxin B

Pronunciation: BOT-ue-li-num
Class: Botulinum toxin

Trade Names

Myobloc
- Injection, solution 5,000 units/mL

Pharmacology

Interferes with neurotransmitter release by cleaving synaptic vesicle-associated membrane protein.

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Pharmacokinetics

Duration

12 and 16 wk at doses of 5,000 or 10,000 units.

Indications and Usage

Reduction of severity of abnormal head position and neck pain in adult patients with cervical dystonia.

Unlabeled Uses

Sialorrhea (drooling).

Contraindications

Known hypersensitivity; infection at the injection site.

Dosage and Administration

Adults

IM In patients with known history of tolerance, 2,500 to 5,000 units divided among affected muscles. In patients without a history of tolerating botulinum toxin, administer a lower initial dose than in patients with known history of tolerance, adjusting subsequent doses based on individual response.

General Advice

  • Ready to use; no reconstitution required.
  • May be diluted with sterile normal saline.
  • Do not shake vials.
  • Do not add other medications to vial.
  • Do not administer if particulate matter, cloudiness, or discoloration is noted.
  • Use a new, sterile needle and syringe to enter vial on each occasion for removal of medication.
  • Follow institutional or organizational procedures for discarding medical waste when disposing of unused solution, vials, and equipment used with the drug administration.
  • The effect of adding different botulinum neurotoxin serotypes at the same time or within less than 4 mo of each other is unknown; however, neuromuscular paralysis may be potentiated by coadministration or overlapping administration of different botulinum toxin serotypes.

Storage/Stability

Store at 36° to 46°F. Do not freeze. Protect from light. Discard any solution that is not used within 4 h of dilution.

Drug Interactions

Aminoglycosides, drugs interfering with neuromuscular transmission (eg, tubocurarine), other botulinum neurotoxin

The effects of botulinum toxin may be potentiated.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Vasodilation (at least 2%).

CNS

Neck pain related to cervical dystonia (17%); headache (16%); pain related to cervical dystonia/torticollis (10%); torticollis (8%); asthenia, dizziness (6%); anxiety, confusion, hyperesthesia, migraine, somnolence, tremor, vertigo (at least 2%).

Dermatologic

Ecchymosis, pruritus (at least 2%).

EENT

Rhinitis (5%); abnormal vision, amblyopia, otitis media, taste perversion, tinnitus (at least 2%).

GI

Dry mouth (34%); dysphagia (25%); dyspepsia, nausea (10%); GI disorder, glossitis, stomatitis, tooth disorder, vomiting (at least 2%); constipation (postmarketing).

Genitourinary

Cystitis, UTI, vaginal moniliasis (at least 2%).

Local

Injection-site pain (16%).

Metabolic-Nutritional

Edema, hypercholesterolemia, peripheral edema (at least 2%).

Musculoskeletal

Arthralgia, back pain (7%); myasthenia (6%); arthritis, joint disorder (at least 2%).

Respiratory

Increased cough (7%); dyspnea, lung disorder, pneumonia (at least 2%).

Miscellaneous

Infection (15%); pain (13%); flu syndrome (9%); accidental injury (5%); abscess, allergic reaction, chest pain, chills, cyst, fever, hernia, malaise, neoplasm, viral infections (at least 2%).

Precautions

Warnings

Postmarketing reports indicate that the effects of botulinum toxin type B and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable with those used to treat cervical dystonia and at lower doses.


Monitor

Monitor patient for injection-site reactions (eg, bruising, pain, tenderness), CNS, GI, and general body side effects. Monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders closely.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Safety and efficacy not established in patients 75 yr of age and older.

Albumin

Because this product contains albumin, a derivative of human blood, it carries a remote risk of viral disease transmission.

Dysphagia/Breathing difficulties

May occur for several months as a consequence of weakening of muscles in the area of injection, and may require the insertion of a gastric feeding tube.

Immunogenicity

Treatment with rimabotulinumtoxin B may cause formation of neutralizing antibodies that may reduce the efficacy of subsequent rimabotulinumtoxin B treatments.

Interchangeability

Units of biological activity of rimabotulinumtoxin B cannot be compared with or converted into units of any other botulinum toxin products.

Neuromuscular disorders

Use with caution in patients with neuromuscular diseases because of increased risk of systemic effects, including severe dysphagia and respiratory compromise.

Overdosage

Symptoms

Muscle paralysis, systemic weakness.

Patient Information

  • Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
  • Advise patient being treated for cervical dystonia that improvement should be noted within the first 2 wk following treatment, and max improvement should be noted at about 6 wk following treatment. Advise patient that beneficial effects may last 3 to 4 mo before retreatment is needed.
  • Advise patient or caregiver to immediately seek medical assistance if swallowing, speech, or breathing problems develop.
  • Advise patient to report intolerable injection-site reactions or unusual symptoms to health care provider.
  • Advise patient or caregiver to read the Medication Guide before each treatment session.

Copyright © 2009 Wolters Kluwer Health.

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