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MIGLUSTAT (miglustat)
- Gaucher's disease
100 mg capsule
- 1 capsule (100 mg) by oral route 3 times per day
100 mg capsule
- 1 capsule (100 mg) by oral route 3 times per day
Gaucher's disease
- 1 capsule (100 mg) by oral route 3 times per day
- None
Contraindicated
- None
Severe
Moderate
- None
- Lactating mother
- Renal disease with moderate to severe impairment
Contraindicated
- None
Severe
Moderate
- Peripheral neuropathy
- Renal disease with mild to moderate impairment
- Thrombocytopenic disorder
- Tremor
MIGLUSTAT (miglustat)
- Gaucher's disease
- None
- Abdominal pain with cramps
- Diarrhea
- Flatulence
- Headache disorder
- Weight loss
More Frequent
Severe
Less Severe
- None
- Constipation
- Cramps in legs
- Dizziness
- General weakness
- Nausea
- Tremor
- Visual changes
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Thrombocytopenic disorder
Less Severe
- Abdominal distension
- Anorexia
- Back pain
- Chills
- Cramps
- Dyspepsia
- Flu-like symptoms
- Hypesthesia
- Limb pain
- Memory impairment
- Menstrual disorder
- Migraine
- Muscle weakness in limbs
- Pain
- Paresthesia
- Unsteady gait
- Xerostomia
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Miglustat
Safety and efficacy not established. Initial safety trials demonstrated decreased height and weight.
- 1 Day – 18 Years
- Safety and efficacy not established. Initial safety trials demonstrated decreased height and weight.
Miglustat
- Severity Level:
C
- Additional Notes: Developm. tox in animal at 2x human dose; consider benefit of therapy vs risks
Contraindicated
Miglustat
Potential for infant adverse outcomes based on pharmacology
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Potential for infant adverse outcomes based on pharmacology |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Miglustat
Renal-Adjust starting dose for CrCL = 50-70 mL/min to 100mg BID; CrCL = 30-50 mL/min to 100mg QD. Gastrointestinal-Monitor closely for diarrhea and weight loss. Neuro/Psych-Monitor for new onset tremor or exacerbation of pre-existing tremor. Consider dose decrease. Monitor for peripheral neuropathy and consider risk for falls.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | Y | N | N | Y | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Gaucher's disease | |
| E75.22 | Gaucher disease |
| 0-9 | A-Z |
|---|---|
| E75.22 | Gaucher disease |
Formulary Reference Tool