• Mild to moderate type 1 Gaucher's disease, when enzyme replacement therapy is not an option.

Contraindicated in:

• Hypersensitivity
• Severe renal impairment (<30 mL/min)
• Lactation: Lactation.

Use Cautiously in:

• Mild to moderate renal impairment (dose alteration recommended if CCr <70 mL/min)
• OB: Safety not established in pregnancy
• Pedi: Safety and effectiveness not established in children
• Geri: Consider age related ↓ in body mass, cardiac, renal and hepatic function, other chronic illnesses and concurrent drug therapies.

CNS: headache.

GI: abdominal pain, diarrhea, flatulence, nausea, weight loss, anorexia, dyspepsia.

GU: ↓male fertility.

Hemat: thrombocytopenia.

Metab: weight loss.

Neuro: paresthesia, peripheral neuropathy, tremor.

Drug-Drug:

• ↓levels and effectiveness of imiglucerase; avoid concurrent use.

(Generic available)

• Capsules: 100 mg ;

• PO (Adults): 100 mg three time daily at regular intervals.

Zavesca

• Competitively and reversibly inhibits glucosylceramide synthase which is the initial step in the production of glycosphingolipids. The glycosphingolipid glucosylceramide accumulates in tissue in Gaucher's disease.

• Decreased production/accumulation of glycosphingolipid glucosylceramide with decreased tissue damage.

Therapeutic Classification: n/a

Pharmacologic Classification: enzyme inhibitors (D-glucose analogue), substrate reduction therapy

Absorption: Well absorbed following oral administration.

Distribution: Distributes into extravascular tissues.

Metabolism/Excretion: Not metabolized; excreted mostly unchanged in urine.

Half-life: 6–7 hr.

(blood levels)

• Instruct patient to take miglustat as directed at the same time each day. If a dose is missed, skip the dose and take the next capsule at the usual time. Advise patient that sharing of this medication may be dangerous.
• Advise patient to consult health care professional prior to taking and Rx or OTC mediations or herbal products concurrently with miglustat.
• Instruct patient to notify healthcare professional if numbness, pain, or burning in the hands and feet occur or if tremor develops or existing tremor worsens.
• Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.

mi-gloo-stat

NDC Code^*

• 10148- CoTherix, Inc.
  • 10148-201- Miglustat
    • 10148-201-90- 6 BLISTER PACK in 1 CARTON (10148-201-90) > 15 CAPSULE in 1 BLISTER PACK (10148-201-15)

• 43975- Amerigen Pharmaceuticals Inc.
  • 43975-310- MIGLUSTAT
    • 43975-310-08- 15 CAPSULE in 1 BLISTER PACK (43975-310-08)

• 43975- Amerigen Pharmaceuticals Inc.
  • 43975-310- MIGLUSTAT
    • 43975-310-83- 6 CAPSULE in 1 CARTON (43975-310-83)

• 66215- Actelion Pharmaceuticals US, Inc.
  • 66215-201- Zavesca
    • 66215-201-90- 6 BLISTER PACK in 1 CARTON (66215-201-90) > 15 CAPSULE in 1 BLISTER PACK (66215-201-15)