Drug Name:
ZAVESCA Rx
Generic Name and Formulations:
Miglustat 100mg; caps.
Company:
Actelion Pharmaceuticals
Therapeutic Use:
Indications for ZAVESCA:
Mild to moderate type 1 Gaucher disease when enzyme replacement therapy is not feasible.
Adult:
≥18yrs: 100mg 3 times daily; may reduce to 100mg once or twice daily if diarrhea or tremor occurs. Mild renal impairment (CrCl 50–70mL/min): 100mg twice daily. Moderate renal impairment (CrCl 30–50mL/min): 100mg once daily. Severe renal impairment: not recommended.
Children:
<18yrs: not recommended.
Contraindications:
Pregnancy (Cat.X).
Warnings/Precautions:
Perform neurological evaluations at baseline, then periodically at 6-month intervals. Reevaluate and consider discontinuation if signs/symptoms of peripheral neuropathy develop (eg, numbness, tingling). GI disease (eg, inflammatory bowel). Use effective methods of contraception during therapy; men should maintain contraception for 3 months after treatment. Elderly. Labor & delivery. Nursing mothers: not recommended.
Pharmacological Class:
Glucosylceramide synthase inhibitor.
Interactions:
May antagonize imiglucerase.
Adverse Reactions:
Diarrhea, weight loss, tremor, flatulence, abdominal pain, GI disturbances, weakness, headache, dizziness, paresthesia, cramps, thrombocytopenia, reduced spermatogenesis, peripheral neuropathy.
How Supplied:
Caps—18, 90
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