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Type 1 Gaucher Disease
Zavesca® is a glucosylceramide synthase inhibitor indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g. due to allergy, hypersensitivity, or poor venous access).
DOSAGE AND ADMINISTRATION
Instructions For Administration
Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease.
The recommended dose for the treatment of adult patients with type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals. If a dose is missed, the next Zavesca capsule should be taken at the next scheduled time.
It may be necessary to reduce the dose to one 100 mg capsule once or twice a day in some patients due to adverse reactions, such as tremor or diarrhea.
Patients With Renal Insufficiency
In patients with mild renal impairment (adjusted creatinine clearance 50-70 mL/min/1.73 m²), Zavesca administration should commence at a dose of 100 mg twice per day. In patients with moderate renal impairment (adjusted creatinine clearance of 30-50 mL/min/1.73 m²), Zavesca administration should commence at a dose of one 100 mg capsule per day. Use of Zavesca in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m²) is not recommended [see Use in Specific Populations].
Dosage Forms And Strengths
100 mg white opaque hard gelatin capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Storage And Handling
Zavesca® is supplied in hard gelatin capsules containing 100 mg miglustat. Zavesca® 100 mg capsules are white opaque with “OGT 918” printed in black on the cap and “100” printed in black on the body.
Zavesca® 100 mg capsules are packed in blister cards. Five blister cards of 18 capsules are supplied in each carton.
NDC 66215-201-90: carton containing 90 capsules.
NDC 66215-201-18: blister card containing 18 capsules
Store at 20°C to 25°C (68° to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted (see USP Controlled Room Temperature).
Manufactured for: Actelion Pharmaceuticals US Inc. 5000 Shoreline Court, Ste 200 South San Francisco, CA 94080, US (650) 624 6900. Issued: February 2014.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/21/2014
Additional Zavesca Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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