Ivosidenib (Tibsovo) is an important isocitrate dehydrogenase-1 (IDH1) inhibitor, providing an innovative treatment option for patients with various malignant tumors harboring IDH1 mutations.

What Are the Indications of Ivosidenib (Tibsovo)?

Newly Diagnosed Acute Myeloid Leukemia (AML)

Patient Population: Indicated for adult patients with newly diagnosed AML who are 75 years of age or older, or who are ineligible for standard intensive induction chemotherapy due to comorbidities (e.g., severe impairment of cardiac, pulmonary, hepatic, or renal function).

Treatment Regimen: Can be administered as a monotherapy or in combination with azacitidine.

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Patient Population: Indicated for adult patients with AML whose disease has relapsed or is refractory to prior treatment.

Relapsed or Refractory Myelodysplastic Syndromes (MDS)

Patient Population: Indicated for adult patients with MDS whose disease has relapsed or is refractory to prior treatment.

Locally Advanced or Metastatic Cholangiocarcinoma

Patient Population: Indicated for adult patients with locally advanced or metastatic cholangiocarcinoma whose disease has progressed after at least one prior systemic therapy regimen (e.g., regimens containing gemcitabine or 5-fluorouracil).

Dosage Form and Appearance of Ivosidenib (Tibsovo)

Dosage Strength: Each tablet contains 250 mg of active ingredient.

Appearance: The tablets are blue and oval-shaped, engraved with "IVO" on one side and "250" on the other for easy identification.

Packaging: Typically supplied in bottles containing 60 tablets each, with a desiccant canister inside the bottle to maintain drug stability.

Storage and Handling Requirements for Ivosidenib (Tibsovo)

Storage Temperature

Store at controlled room temperature between 20°C and 25°C (68°F and 77°F).

Short-term storage between 15°C and 30°C (59°F and 86°F) is permitted.

Storage Conditions

Keep the medication in its original bottle, and store in a dry place, protected from direct sunlight, moisture, and excessive heat.

Important Notes

The desiccant canister inside the bottle is used for moisture absorption and preservation; do not remove or discard it.

Keep the medication out of the reach and sight of children to ensure safety.