Miglustat
These highlights do not include all the information needed to use miglustat safely and effectively. See full prescribing information for miglustat. miglustat capsules, for oral use Initial U.S. Approval: 2003
76eb7ac8-e0ee-4409-a4e7-e326c6725836
HUMAN PRESCRIPTION DRUG LABEL
Apr 25, 2023
CoTherix, Inc.
DUNS: 118290078
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
miglustat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 100 mg Capsule Blister Card Carton
migLUstat
capsules
NDC 10148-201-90
100 mg
This package is not child resistant.
Contents:
90 Capsules (six blister cards of 15 capsules each)
Oral use
Rx only
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Miglustat is supplied in hard gelatin capsules containing 100 mg miglustat. Miglustat 100 mg capsules are white opaque with "OGT 918" printed in black on the cap and "100" printed in black on the body.
Miglustat 100 mg capsules are packed in blister cards. Six blister cards of 15 capsules are supplied in each carton.
NDC 10148-201-90: carton containing 90 capsules
NDC 10148-201-15: 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.
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Information for Patients
- Advise patients that the most common serious adverse reaction reported with miglustat is peripheral neuropathy. Advise patients to promptly report any numbness, tingling, pain, or burning in the hands and feet [see Warnings and Precautions (5.1)] .
- Advise patients that other adverse reactions include tremor and reductions in platelet counts. Advise patients to promptly report the development of tremor or worsening in an existing tremor [see Warnings and Precautions (5.2, 5.4)].
- Advise patients that other serious adverse reactions include diarrhea and weight loss. Advise patients to adhere to dietary instructions [see Warnings and Precautions (5.3)] .
- Advise patients to take the next miglustat capsule at the next scheduled time if a dose is missed.
- Inform patients of the potential risks and benefits of miglustat and of alternative modes of therapy.
Pregnancy
Advise pregnant women and females of reproductive potential of the potential risk to a fetus, based on animal data. Advise patients who may become pregnant to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed if they are taking miglustat [see Use in Specific Populations (8.2)].