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According to the European Medicines Agency, brand name Cerdelga originating from Europe is manufactured at the following site(s):Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37100 Tours FranceSanofi Winthrop Industrie 1 rue de la Vierge Ambares et Lagrave 33565 Carbon Blanc cedex FranceGenzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford Ireland
Information about Cerdelga (Eliglustat)
Cerdelga is a medication used to manage Gaucher disease type 1, a genetic disorder caused by the deficiency of the enzyme glucocerebrosidase. Eliglustat, the active ingredient, is a specific oral treatment option designed to help manage this condition by inhibiting the enzyme responsible for the production of glucosylceramide.
Product Highlights
- Cerdelga is primarily indicated for the long-term treatment of adults with Gaucher disease type 1, particularly those who are treatment-naïve or have had stable disease with enzyme replacement therapy.
Key Ingredient
Key Benefits
- Cerdelga is taken orally, which can be more convenient compared to intravenous enzyme replacement therapies.
- It can help reduce or normalize Gaucher disease-related symptoms such as hepatosplenomegaly (enlarged liver and spleen), anemia, and bone pain.
- It has a manageable safety profile compared to other therapies.
Direction of Use
- The typical recommended dosage is 84 mg or 100 mg taken orally twice daily, based on specific patient factors like genotype, drug interactions, and tolerance.
- Swallow the capsules whole with a glass of water; do not chew or crush them.Swallow the capsules whole with a glass of water; do not chew or crush them.
Safety Concerns
- Common side effects may include headache, diarrhea, nausea, and fatigue.
- Serious side effects could include severe liver issues, heart rhythm disturbances, and low blood cell counts.
- Regular monitoring of liver function, blood counts, and other parameters is essential to ensure safety and efficacy.
- Eliglustat can interact with certain medications, especially those that affect liver enzymes, so it's important to discuss all current medications with a healthcare provider.
Avoid Cerdelga (Eliglustat) If
- Patients with severe liver impairment should avoid Cerdelga, as it may exacerbate liver issues.
- Avoid use if the patient is on medications that significantly affect CYP3A or UGT2B4/UGT2B7 enzyme systems, as these can affect the metabolism of Eliglustat.
- The safety of Cerdelga during pregnancy and breastfeeding has not been fully established; hence, it should be used only if clearly needed and after evaluating risks and benefits.