Ivosidenib package insert

GSK's Arexvy package insert Pfizer's Abrysvo package insert Moderna's mResvia package insert. To learn more, see ACIP Contraindications

Ivosidenib is the first approved oral, targeted, small-molecule inhibitor of the isocitrate dehydrogenase 1 (IDH1) mutation seen in AML. be decreased to 250 mg daily per the package insert

strong CYP3A inducers: apalutamide, carbamazepine, enzalutamide, ivosidenib, lumacaftor, mitotane, phenytoin, rifampin, St. John’s wort; Jaypirca Package Insert . Review the Jaypirca Package Insert for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider.

The product package insert recommends considering other therapies that are not strong CYP3A4 inhibitors while patients receive glasdegib . If strong CYP3A4 inhibitors cannot be avoided, Ivosidenib (Tibsovo ) Ivosidenib is an IDH1 inhibitor that was FDA approved in

Ivosidenib is the predominant component ( 92%) of total radioactivity in plasma and primarily metabolized by CYP3A4 with minor N-dealkylation and hydrolytic pathways. After a single oral administration, 77% of ivosidenib was eliminated in the feces Tibsovo [package insert]. Cambridge, MA: Agios Pharmaceuticals Inc.; 2025.

Such interactions are likely due to the induction of CYP2C9 by ivosidenib. 13 However, the FDA-approved package insert still recommends reducing the dose of ivosidenib when prescribed with moderate/strong CYP3A4 inhibitors such as voriconazole or posaconazole, even though this does not reflect the dosing used in the phase 1 study by DiNardo et

Ivosidenib (Tibsovo) package insert; Ivosidenib (Tibsovo) patient drug information (Chemocare) History of changes in FDA indication Acute myeloid leukemia. : Granted approval for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.

View All Manufacturers Suppliers of Ivosidenib API with Drug Master Files (DMF), CEP/COS, Japanese DMFs, Written Confirmation (WC) details listed on PharmaCompass.com - Package Integrity Testing - Packaging Materials Testing - Package Insert - Pipette - Polymer - Pre-Filled Syringe - Pump / Spray - Spoon - Syringe Needle - Tube

Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2025. 2. Data on file. Servier Pharmaceuticals LLC. 3. Servier announces FDA approval of TIBSOVO (ivosidenib tablets) for the treatment of IDH1-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). Servier Pharmaceuticals LLC.