Zavesca (Miglustat) - Indications and Dosage

INDICATIONS AND USAGE

ZAVESCA® 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® 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 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® 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

Rx only

Manufactured by:

Galen Limited,

Craigavon, Co. Armagh, BT63 5UA, UK

Marketed and Distributed by:

Actelion Pharmaceuticals US Inc

South San Francisco, CA 94080, US.

(650) 624 6900

Package Insert Preparation: July 31, 2003