Ivosidenib (Tibsovo) is an oral isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with various malignant tumors harboring specific IDH1 gene mutations. By inhibiting the activity of mutated IDH1 enzyme, the drug reduces the level of 2-hydroxyglutarate (2-HG) in the body, thereby promoting the differentiation and apoptosis of tumor cells.

What Are the Indications for Ivosidenib (Tibsovo)?

Newly Diagnosed Acute Myeloid Leukemia (AML)

Indicated for adult patients aged 75 years or older, or those who are ineligible for intensive induction chemotherapy due to comorbidities.

May be administered as a single agent or in combination with azacitidine.

Relapsed or Refractory Acute Myeloid Leukemia (AML)

Indicated for the treatment of adult patients with AML who have relapsed or remain refractory following prior therapy.

Relapsed or Refractory Myelodysplastic Syndromes (MDS)

Indicated for adult patients with MDS who have failed prior treatment or experienced disease relapse.

Locally Advanced or Metastatic Cholangiocarcinoma

Indicated for adult patients with disease progression after receiving at least one prior systemic therapy.

Dosage Form and Characteristics of Ivosidenib (Tibsovo)

Dosage Form

Each tablet of ivosidenib contains 250 mg of the active ingredient.

Characteristics

The tablets are blue, oval, film-coated tablets, engraved with "IVO" on one side and "250" on the other side.

The product is packaged in high-density polyethylene bottles containing 60 tablets, with a desiccant included in each bottle.

Ingredients

Active Ingredient: Ivosidenib.

Inactive Ingredients: Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, etc.

Film Coating Ingredients: FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

Storage Methods for Ivosidenib (Tibsovo)

Storage Temperature

Store at 20°C to 25°C (room temperature).

Brief excursions to 15°C to 30°C are permitted, but prolonged exposure to this temperature range should be avoided.

Moisture and Light Protection

Do not remove the desiccant from the bottle to prevent moisture damage to the tablets.

No special light protection is required, but it is recommended to store the drug in its original packaging to avoid direct sunlight.

Precautions for Storage

Keep the drug out of the reach of children.

Do not store the drug in humid environments such as bathrooms or kitchens.

Do not take the tablets if they show discoloration, damage, or any other abnormalities.