Botulinum Toxin Type B

Trade Names:
Myobloc
- Solution, injectable 5,000 units/mL

Pharmacology

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

Indications and Usage

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

Contraindications

Standard considerations.

Dosage and Administration

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

• May be diluted with sterile normal saline. Discard any unused solution that is not used within 4 h of dilution.
• Do not add other medications to vial.
• Do not administer if particulate matter, cloudiness, or discoloration 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 unused solution, vials, and equipment used with the drug administration.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F). Do not freeze. Do not shake vials.

Drug Interactions

The effects of botulinum toxin may be potentiated.

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.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Migraine, vasodilation (at least 2%).

CNS

Headache (11%); dizziness (6%); anxiety, tremor, hyperesthesia, somnolence, confusion, vertigo (at least 2%).

Dermatologic

Pruritus (at least 2%).

EENT

Amblyopia, otitis media, abnormal vision, taste perversion, tinnitus (at least 2%).

GI

Dry mouth (34%); dysphagia (25%); dyspepsia (10%); nausea (8%); vomiting, glossitis, stomatitis, tooth disorder (at least 2%).

Genitourinary

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

Hematologic-Lymphatic

Ecchymosis (at least 2%).

Local

Injection site pain (15%).

Metabolic-Nutritional

Peripheral edema, edema, hypercholesterolemia (at least 2%).

Musculoskeletal

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

Respiratory

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

Miscellaneous

Neck pain related to cervical dystonia (17%); infection (15%); pain (13%); flu syndrome, torticollis (8%); back pain (7%); asthenia (6%); accidental injury (5%); allergic reaction, fever, chest pain, chills, hernia, malaise, abscess, cyst, neoplasm, viral infections (at least 2%).

Precautions

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

Dysphagia is a commonly reported adverse reaction of treatment with all botulinum toxins in cervical dystonia patients and may be severe enough in some cases to warrant insertion of a gastric feeding tube.

Neuropathic disorders

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

Overdosage

Symptoms

Systemic weakness, muscle paralysis.

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.

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