What is ZAVESCA and how is it used?
It is not known if ZAVESCA is safe and effective in children under 18 years of age.
What are the possible side effects of ZAVESCA?
ZAVESCA may cause serious side effects including:
The most common side effects of ZAVESCA include:
These are not all of the possible side effects of ZAVESCA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Zavesca (miglustat capsules, 100 mg) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids.
Zavesca is an N-alkylated imino sugar, a synthetic analog of D-glucose.
The chemical name for miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol with the chemical formula C10H21NO4 and a molecular weight of 219.28.
Miglustat is a white to off-white crystalline solid and has a bitter taste. It is highly soluble in water (>1000 mg/mL as a free base).
Zavesca is supplied in hard gelatin capsules each containing 100 mg miglustat for oral administration. Each Zavesca 100 mg capsule also contains sodium starch glycollate, povidone (K30), and magnesium stearate. Ingredients in the capsule shell include gelatin and titanium dioxide, and the shells are printed with edible ink consisting of black iron oxide and shellac.
ZAVESCA is 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).
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.
In patients with mild renal impairment (adjusted creatinine clearance 50-70 mL/min/1.73 m2), initiate ZAVESCA treatment 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), initiate ZAVESCA treatment at a dose of one 100 mg capsule per day. ZAVESCA is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min/1.73 m2) [see Use In Specific Populations].
100 mg of miglustat, white opaque hard gelatin capsules with “OGT 918” printed in black on the cap and “100” printed in black on the body.
ZAVESCA is supplied in hard gelatin capsules containing 100 mg of 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. Six blister cards of 15 capsules are supplied in each carton.
NDC 66215-201-90: carton containing 90 capsules
NDC 66215-201-15: blister card containing 15 capsules
Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature].
Keep out of reach of children.
The following serious adverse reactions are described below and elsewhere in the labeling: