MIGLUSTAT capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Breckenridge Pharmaceutical, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Miglustat capsules are 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, miglustat capsules may cause fetal harm when administered to a pregnant woman. Available data from postmarketing case reports with miglustat capsules 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 toxicities in rats at doses tw

Produktbesonderheiten:

Miglustat capsules are supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white opaque with "B 007" printed in black. Miglustat 100 mg capsules are packed in 90 count bottles. NDC 51991-959-90: bottle containing 90 capsules. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MIGLUSTAT- MIGLUSTAT CAPSULE
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIGLUSTAT CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIGLUSTAT
CAPSULES.
MIGLUSTAT CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Miglustat capsules are 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, constipa