pixel

This site is intended for U.S. healthcare professionals.

TIBSOVO® (ivosidenib) Logo

FIRST-IN-CLASS TARGETED INHIBITION OF mIDH1,

an early driver mutation in acute myeloid leukemia (AML) and cholangiocarcinoma (CCA).1–3

TIBSOVO® (ivosidenib tablets) is a once-daily, oral differentiation therapy for the treatment of adult patients who have a susceptible IDH1 mutation as detected by an FDA-approved test with1,2:

Acute myeloid leukemia toggle arrow

In combination with azacitidine for newly diagnosed, IC-ineligible AML or as monotherapy for newly diagnosed, IC-ineligible AML and R/R AML2

Cholangiocarcinoma toggle arrow

For previously treated, locally advanced or metastatic CCA2

IC, induction chemotherapy; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; R/R, relapsed or refractory.

References: 1. Popovici-Muller J, Lemieux RM, Artin E, et al. Discovery of AG-120 (ivosidenib): a first-in-class mutant IDH1 inhibitor for the treatment of IDH1 mutant cancers. ACS Med Chem Lett. 2018;9(4):300-305. doi:10.1021/acsmedchemlett.7b00421 2. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 3. Molenaar RJ, Maciejewski JP, Wilmink JW, van Noorden CJF. Wild-type and mutated IDH1/2 enzymes and therapy responses. Oncogene. 2018;37(15):1949-1960. doi:10.1038/s41388-017-0077-z

 

INDICATIONS

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy
  • Relapsed or refractory AML.
Indications & Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.