TIBSOVO

This brand name is authorized in Lithuania, United States

Active ingredients

The drug TIBSOVO contains one active pharmaceutical ingredient (API):

1 Ivosidenib
UNII Q2PCN8MAM6 - IVOSIDENIB

Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. Susceptible IDH1 mutations are defined as those leading to increased levels of 2-hydroxyglutarate (2-HG) in the leukemia cells and where efficacy is predicted by 1) clinically meaningful remissions with the recommended dose of ivosidenib and/or 2) inhibition of mutant IDH1 enzymatic activity at concentrations of ivosidenib sustainable at the recommended dosage according to validated methods. The most common of such mutations are R132H and R132C substitutions.

Read about Ivosidenib

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
TIBSOVO Film-coated tablet FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01XX62 L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XX Other antineoplastic agents
Discover more medicines within L01XX62

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: LT Valstybinฤ— vaistลณ kontrolฤ—s tarnyba Identifier(s): 1097094
Country: US FDA, National Drug Code Identifier(s): 71334-100

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