Ivosidenib 250 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 250 mg

Reference Brands: Tibsovo (USA/EU)

Category: Oncology Cancer Care

Ivosidenib 250 mg film-coated tablets, an oral IDH1 inhibitor for IDH1-mutated acute myeloid leukaemia and cholangiocarcinoma. For hospital haematology and oncology pharmacies, importers and distributors.

Product Description:

Ivosidenib is an oral, selective inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). The mutated enzyme makes an abnormal metabolite, 2-hydroxyglutarate, which blocks normal cell maturation; ivosidenib cuts its production and lets malignant cells differentiate again. It is supplied as 250 mg film-coated tablets. The usual dose is 500 mg once daily, taken as two tablets. It only works in tumours with an IDH1 mutation, which must be confirmed with a validated test before prescribing.

Approved uses include IDH1-mutated acute myeloid leukaemia, newly diagnosed in adults unfit for intensive chemotherapy, often with azacitidine, and in some markets relapsed or refractory disease. It is also used for previously treated, advanced cholangiocarcinoma with an IDH1 mutation, and in some markets for myelodysplastic syndromes. Differentiation syndrome is the key warning in leukaemia and needs prompt corticosteroids. ECGs are checked for QT prolongation. Strong CYP3A4 inhibitors need a dose reduction, inducers are avoided, and so are high-fat meals.

Sourcing notes. Ivosidenib is a recent targeted medicine, so ask how the offered product is registered in your market and whether it is the originator or a generic permitted under local patent rules. A CTD dossier is standard. Confirm the storage condition and ask for zone IVb stability data for tropical markets. Each lot needs a CoA, with a site GMP certificate and a CoPP on file. It is prescription-only and usually dispensed by hospital haematology or oncology pharmacies. Treatment depends on a companion diagnostic, so check which IDH1 test is approved locally. Specify pack size, quantity and remaining shelf life.