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Zavesca Generic Name & Formulations
Legal Class
Rx
General Description
Miglustat 100mg; caps.
Pharmacological Class
Glucosylceramide synthase inhibitor.
How Supplied
Caps—18, 90
Manufacturer
Generic Availability
YES
Zavesca Indications
Indications
Mild to moderate type 1 Gaucher disease when enzyme replacement therapy is not feasible.
Zavesca Dosage and Administration
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 established.
Zavesca Contraindications
Not Applicable
Zavesca Boxed Warnings
Not Applicable
Zavesca Warnings/Precautions
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). Monitor platelets. Renal impairment. Elderly. Pregnancy. Nursing mothers: not recommended.
Zavesca Pharmacokinetics
See Literature
Zavesca Interactions
Interactions
May antagonize imiglucerase.
Zavesca Adverse Reactions
Adverse Reactions
Diarrhea, weight loss, tremor, flatulence, abdominal pain, GI disturbances, weakness, headache, dizziness, paresthesia, cramps, vision problems, thrombocytopenia, back pain, dry mouth, menstrual changes; reduced spermatogenesis, peripheral neuropathy.
Zavesca Clinical Trials
See Literature
Zavesca Note
Not Applicable
Zavesca Patient Counseling
See Literature
