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YARGESA (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
100 mg capsule
- 1 capsule (100 mg) by oral route 3 times per day
65 mg capsule
- Dosage information is not available
Default screening record
- 1 capsule (100 mg) by oral route 3 times per day
- None
Contraindicated
- None
Severe
Moderate
- None
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Lactation
Contraindicated
- Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min
- Chronic kidney disease stage 3A (moderate) GFR 45-59
- Chronic kidney disease stage 3B (moderate) GFR 30-44
- Pregnancy
Severe
Moderate
- Peripheral neuropathy
- Thrombocytopenic disorder
- Tremor
YARGESA (miglustat)
- Gaucher's disease
- None
- Acute abdominal pain
- Cramps
- Diarrhea
- Flatulence
- Headache disorder
- Nausea
- Weight loss
More Frequent
Severe
Less Severe
- Peripheral neuropathy
- Abdominal distension
- Anorexia
- Constipation
- Cramps in legs
- Dizziness
- Dyspepsia
- Gait abnormality
- General weakness
- Memory impairment
- Menstrual disorder
- Migraine
- Paresthesia
- Tremor
- Visual changes
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Thrombocytopenic disorder
Less Severe
- Back pain
- Chills
- Flu-like symptoms
- Hypoesthesia
- Muscle weakness in limbs
- Pain
- Pain in extremities
- 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 (type 1 Gaucher Disease)
- Severity Level:
D
- Additional Notes: Based on animal data, fetal harm may occur.
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