Yargesa 100 mg/1
Miglustat · CAPSULE · Edenbridge Pharmaceuticals LLC.
Yargesa is a capsule containing miglustat at 100 mg/1, taken oral. Manufactured by Edenbridge Pharmaceuticals LLC..
Key Facts
- Brand Name
- Yargesa
- Generic Name
- Miglustat
- NDC Code (Product)
42799-709- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209821
- Drug Class
- Glucosylceramide Synthase Inhibitor [EPC]; Enzyme Stabilizer [EPC]
- Marketing Start
- 08/06/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE YARGESA is 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 ). 1.1 Type 1 Gaucher Disease YARGESA is 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).
Dosage & Administration
2 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 2 ) 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 2.1 Instructions for Administration Therapy should be directed by physicians who are knowledgeable in the management of Gaucher disease. The recommended dose for the treatment of adult patients with type 1 Gaucher disease is one 100 mg capsule administered orally three times a day at regular intervals. If a dose is missed, the next YARGESA capsule should be taken at the next scheduled time. It may be necessary to reduce the dose to one 100 mg capsule once or twice a day in some patients due to adverse reactions, such as tremor or diarrhea. 2.2 Patients with Renal Insufficiency In patients with mild renal impairment (adjusted creatinine clearance 50-70 mL/min/1.73 m 2 ), initiate YARGESA treatmen…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS While co-administration of miglustat capsules appeared to increase the clearance of imiglucerase by 70%, these results are not conclusive because of the small number of patients studied and because patients took variable doses of imiglucerase [ see Clinical Pharmacology (12.3) ]. Co-administration of YARGESA and imiglucerase may lead to increased clearance of imiglucerase ( 7 ).
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Peripheral Neuropathy [ see Warnings and Precautions (5.1) ] • Tremor [ see Warnings and Precautions (5.2) ] • Diarrhea and weight loss [ see Warnings and Precautions (5.3) ] • Reductions in platelet count [ see Warnings and Precautions (5.4) ] The most common adverse reactions (incidence ≥ to 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, constipation, dry mouth, heaviness in arms and legs, memory loss, unsteady walking, anorexia, indigestion, paresthesia, stomach bloating, stomach pain not related to food, and menstrual changes ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another d…
Frequently Asked Questions
What is Yargesa used for?
Yargesa contains Miglustat. It is a capsule taken oral. Consult your doctor for specific uses.
Is Yargesa a controlled substance?
Yargesa is not classified as a controlled substance by the DEA.
What is the generic name for Yargesa?
The generic name for Yargesa is Miglustat. There are 6 other brand versions of Miglustat.
What is the NDC code for Yargesa 100 mg/1?
The NDC (National Drug Code) for Yargesa 100 mg/1 is 42799-709, listed by Edenbridge Pharmaceuticals LLC..