ZAVESCA- miglustat capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

MIGLUSTAT (UNII: ADN3S497AZ) (MIGLUSTAT - UNII:ADN3S497AZ)

可用日期:

Actelion Pharmaceuticals US, Inc.

INN（国际名称）:

miglustat

组成:

miglustat 100 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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). None. Risk Summary Based on findings from animal reproduction studies, ZAVESCA may cause fetal harm when administered to a pregnant woman. Available data from postmarketing case reports with ZAVESCA use in pregnancy are insufficient to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks associated with symptomatic Type I Gaucher disease in pregnancy, including hepatosplenomegaly and thrombocytopenia (see Clinical Considerations). Advise pregnant women of the potential risks to the fetus. In animal reproduction studies, miglustat was maternally toxic in rabbits at exposures near the expected human therapeutic dose and caused embryo-fetal toxicitie

產品總結:

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 Storage 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.

授权状态:

New Drug Application

产品特点

ZAVESCA- MIGLUSTAT CAPSULE
ACTELION PHARMACEUTICALS US, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZAVESCA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZAVESCA.
ZAVESCA (MIGLUSTAT) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
ZAVESCA is a glucosylceramide synthase inhibitor indicated as
monotherapy for treatment of adult
patients with mild/moderate type 1 Gaucher disease for whom enzyme
replacement therapy is not a
therapeutic option ( 1.1).
DOSAGE AND ADMINISTRATION
Recommended dosage is 100 mg administered orally three times a day at
regular intervals ( 2.1).
May reduce dosage to 100 mg once or twice a day in some patients due
to tremor or diarrhea ( 2.1).
Adjust in patients with renal impairment ( 2.2):
RENAL IMPAIRMENT
ADJUSTED CREATININE CLEARANCE
(IN ML/MIN/1.73 M
)
RECOMMENDATIONS
Mild
50 – 70
Start dose at 100 mg twice a day
Moderate
30 – 50
Start dose at 100 mg once a day
Severe
<30
Use is not recommended
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg ( 3)
CONTRAINDICATIONS
None ( 4).
WARNINGS AND PRECAUTIONS
Peripheral neuropathy: Perform baseline and follow-up neurological
evaluations at 6-month intervals in
all patients ( 5.1).
Tremor: Reduce dose to ameliorate tremor or discontinue treatment if
tremor does not resolve within
days of dose reduction ( 5.2).
Diarrhea and weight loss: Evaluate for underlying gastrointestinal
disease in patients who do not
respond to usual interventions (e.g. diet modification) ( 5.3).
Reductions in Platelet Count: Mild reductions in platelet counts
without association with bleeding were
observed in some patients. Monitoring of platelet counts is
recommended ( 5.4).
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5%) are: diarrhea,
weight loss, stomach pain, gas,
nausea and vomiting headache including migraine, tremor, leg cramps,
dizziness, weakness, vision
problems, thrombocytopenia, muscle cramps, back pain, constipation,
dry mouth