What is Yargesa used for?

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, hyperse

How does Yargesa work?

11 DESCRIPTION YARGESA (miglustat capsules) is an inhibitor of the enzyme glucosylceramide synthase, which is a glucosyl transferase enzyme responsible for the first step in the synthesis of most glycosphingolipids.

What pharmaceutical form is Yargesa available in?

Yargesa: Kapsułki twarde 100 mg (doustna)

What are the side effects of Yargesa?

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 m

Who should NOT take Yargesa?

4 CONTRAINDICATIONS None None ( 4 )

Does Yargesa interact with other medications?

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 ).

Can Yargesa be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS • Pregnancy : Based on animal data, may cause fetal harm ( 8.1 ). • Lactation : Breastfeeding not recommend ( 8.2 ). 8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, miglustat capsules may cause fetal harm when administered to a pregnant woman. Available data from postmarketing case reports with miglustat capsules use in pregnancy are insufficient to assess a drug-associated risk of major birth defects, miscarriage, or

What precautions should be taken with Yargesa?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures Yargesa?

Piramal Critical Care B.V. (Holandia)

What ATC class does Yargesa belong to?

Yargesa: ATC A16AX06. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

OTC

Yargesa

100 mg, Kapsułki twarde

INN: Miglustatum

Data updated: 2026-04-13

Available in:

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Form

Kapsułki twarde

Dosage

100 mg

Route

doustna

Storage

—

About This Product

Manufacturer

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