Clostridium Botulinum Toxin Type A Neurotoxin

Uses

This is used for Muscle spasm, Strabismus, Blepharospasm, Achalasia, Cervical dystonia, Limb spasticity, Overactive bladder, Chronic migraine, Severe Primary Axillary Hyperhidrosis, Glabellar and lateral Canthal lines (cosmetic purpose).

Dosage

Clostridium Botulinum Toxin Type A Neurotoxin dosage

Glabellar lines: Inject 4 units (0.1 ml) into each of 5 sites, 2 in each corrugator muscle and 1 in procerus muscle for a total dose of 20 units

Canthal lines: Inject 4 units (0.1 ml) into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 units/0.6 ml (12 units per side)Duration of activity is approximately 3-4 months. More frequent dosing not recommended.

Blepharospasm: 1.25- 2.5 units IM; not to exceed 200 units in 30 days.

Strabismus: 1.25- 5 units IM; <25 units per injection.

Chronic Migraine: Recommended total dose 155 units, as 0.1 ml (5 units) IM injections per each site divided across 7 head/neck muscles q12wk.

Overactive Bladder: Indicated for adults with overactive bladder symptoms (urge incontinence, urgency, frequency) who cannot use or do not adequately respond to anticholinergic medication.

100 units (divided into 20 intradetrusor injections of 5 units each) administered using cystoscopy.

Side Effects

Serious adverse reactions were not observed in clinical trials. The most common adverse reaction was skin rash. Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products.

Precaution

Patient Monitoring for Administration Patients should be well hydrated prior to the initiation. Assess renal function, including the measurement of blood urea nitrogen (BUN) or serum creatinine prior to the initial infusion. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure. Increases in serum creatinine and BUN have been observed as soon as one to two days following treatment with other IGIV products. During administration, monitor the patient's vital signs continuously and observe the patient carefully for any associated symptoms.

Interaction

There are no known drug interactions and none well documented.

Pregnancy & Breastfeeding use

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Contraindication

As with other immunoglobulin preparations, it should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations. Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A.

Innovators Monograph

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