Ivosidenib package insert

Ivosidenib, an oral inhibitor of mIDH1, is currently approved in the United States by the Food and Drug Administration (FDA) and by the European Medicines Agency Studies cited in the Voranigo package insert indicated that there was fetal harm in animal models. 7 Given the paucity of published data, it is advised that female patients should

Enasidenib: Stein EM et al, Blood 2025; Fathi AT et al. JAMA Oncol. 2025; Norsworthy KJ et al. Clin Cancer Res. 2025; FDA package insert. Ivosidenib: DiNardo CD et al. NEJM 2025; Norsworthy KJ et al. Clin Cancer Res. 2025; FDA package insert. Olutasidenib: de Botton S et al. Blood Adv. 2025; FDA package insert.

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

TIBSOVO (ivosidenib tablets) has a well-characterized safety profile studied in more than 270 patients with m IDH1 AML 1. Package insert. Servier Pharmaceuticals LLC; 2025. 2. Montesinos P, Recher C, Vives S, et al. Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia. N Engl J Med

On day 31 of ivosidenib, her platelet count was 189 10 3 /mcL, and on day 34, a bone marrow biopsy confirmed a complete remission (CR) Ivosidenib [package insert]. Cambridge, MA: Agios Pharmaceuticals, Inc; 2025. [Google Scholar] Other Formats. PDF (838K) Actions. Cite; Collections. Add to Collections.

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.

Ivosidenib (Tibsovo ) has info patients should know about. Read, listen, and watch videos about side effects from Ivosidenib (Tibsovo ) for Brain Cancer. especially oral medications, have guidelines in the manufacturer's package insert that help you know when it's okay to resume normal activities (diet, sexual activity, breast feeding

Neurontin [package insert]. New York, NY: Pfizer Inc; 2024. Gralise [package insert]. Horizant [package insert]. Backonja M, Beydoun A

Pradaxa package insert Eliquis package insert Xarelto package insert Authors concluded that the difference between the 2 devices was