Zavesca
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Zavesca
INDICATIONS
ZAVESCA® (miglustat) is indicated 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 constraints such as 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.
It may be necessary to reduce the dose to one 100 mg capsule once or twice a day in some patients for adverse effects, such as diarrhea or tremor.
Patients with Renal Insufficiency
In patients with mild renal impairment (adjusted creatinine clearance 50-70 mL/min/1.73 m2), ZAVESCA® (miglustat) 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® (miglustat) administration should commence at a dose of one 100mg capsule per day. Use of ZAVESCA® (miglustat) in patients with severe renal impairment (creatinine clearance of < 30 mL/min/1.73 m2) is not recommended.
Storage
Store at 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86° F) permitted (see USP Controlled Room Temperature).
HOW SUPPLIED
ZAVESCA® (miglustat) is supplied in hard gelatin capsules containing 100 mg miglustat. ZAVESCA® (miglustat) 100 mg capsules are white opaque with "OGT 918" printed in black on the cap and "100" printed in black on the body.
ZAVESCA® (miglustat) 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
Manufactured for: Actelion Pharmaceuticals US Inc South San Francisco, CA 94080, US (650) 624 6900.
Last reviewed on RxList: 1/11/2011
This monograph has been modified to include the generic and brand name in many instances.
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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