(C) Vancouver General Hospital. This monograph may not be reproduced without permission. For further information, please contact a Pharmacist.

NAME OF DRUG
botulinum toxin type A

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CLASSIFICATION

Neuromuscular paralytic agent 

ALTERNATE NAMES

BOTOX, clostridium botulinum toxin type A

INDICATIONS

• treatment of focal limb spasticity associated with stroke, traumatic brain injury, spinal cord injury, multiple sclerosis, and cerebral palsy
• treatment of patients with achalasia who are not surgical candidates

RECONSTITUTION AND STABILITY

• store in refridgerator
• each vial contains 100 Units of vacuum-dried Clostridium botulinum toxin type A
• reconstitute vial with NS without preservative; inject diluent into the vial along the vial wall. Gently mix by rotating the vial (botulinum toxin is denatured by bubbling or violent agitation). The amount of diluent to add is calculated for an injection volume of 0.1 mL:

NS without preservative to be added to vial	Resulting dose
1.0 mL	10.0 Units/0.1 mL
2.0 mL	5.0 Units/0.1 mL
4.0 mL	2.5 Units/0.1 mL
8.0 mL	1.25 Units/0.1 mL

• diluent volumes can be smaller or larger by 50% to allow for a decrease or increase in botulinum dose (i.e. 0.05mL (50% decrease in dose) to 0.15mL (50% increase in dose))
• reconstituted solutions stable x 4 hours and should be stored in the fridge if not used immediately
• the reconstituted solution should be clear, colourless and free of particulate matter

COMPATIBILITY

• incompatible with other drugs

ROUTES OF ADMINISTRATION

• IM

VH & HSC ADMINISTRATION POLICY

Restricted to Rehab Medicine and Physicians associated with the Spine Cord Program, and GE clinic

C- must be administered by a physician

DOSAGE

Spasticity:

• 10-50 units IM in 1-4 sites depending upon the type of muscle being injected.
• For larger muscles increase dilution and inject in 6-8 sites.
• Do not exceed 8-10 units/kg or 500-600 units per patient

POTENTIAL HAZARDS OF PARENTERAL ADMINISTRATION

• localized pain or tenderness at injection site
• rare: skin rash, pruritis, allergic reaction

IMPORTANT IMPLICATIONS

• paralysis of injected muscles begins 7-10 days after injection and increasing in intensity during the first two weeks; maximum benefit is reached in 6-8 weeks depending on condition being treated. Effects of injection generally last 3-4 months. If spasticity patients are stretched properly, effect will long much longer
• the use of one vial for more than one patient is not recommended as the product and diluent do not contain a preservative
• adverse effects include altered balance, leg pain and local weakness for patients treated for spasticity
• contraindicated in the presence of infection at the proposed injection site
• use with caution in patients with myopathy associated with neuromuscular disease (e.g. amyotrophic lateral sclerosis (ALS), myasthenia gravis)
• the effect of botulinum toxin may be potentiated by aminoglycosides, neuromuscular blockers or other drugs that interfere with neuromuscular transmission

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Rev. May 2007