INDICATIONS AND USAGE（适应症）

Newly-Diagnosed Acute Myeloid Leukemia

TIBSOVO is indicated for the treatment of newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

Relapsed or Refractory Acute Myeloid Leukemia

TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

DOSAGE（服用剂量）

Select patients for the treatment of AML with TIBSOVO based on the presence of IDH1 mutations in the blood or bone marrow. Patients without IDH1 mutations at diagnosis should be retested at relapse because a mutation in IDH1 may emerge during treatment and at relapse.

The recommended dose of TIBSOVO is 500 mg taken orally once daily until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.

Administer TIBSOVO with or without food. Do not administer TIBSOVO with a high-fat meal because of an increase in ivosidenib concentration. Do not split or crush TIBSOVO tablets. Administer TIBSOVO tablets orally about the same time each day. If a dose of TIBSOVO is vomited, do not administer a replacement dose; wait until the next scheduled dose is due. If a dose of TIBSOVO is missed or not taken at the usual time, administer the dose as soon as possible and at least 12 hours prior to the next scheduled dose. Return to the normal schedule the following day. Do not administer 2 doses within 12 hours.

Patients with the Comorbidities of Severe Renal or Severe Hepatic Impairment

Treatment with TIBSOVO has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with TIBSOVO

ADVERSE REACTIONS（不良反应）

Differentiation Syndrome

QTc Interval Prolongation

Guillain-Barré Syndrome

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/5b6d8ae8-bac8-4e1b-b1b4-7f9665e62de5/spl-doc?hl=TIBSOVO

TIBSOVOinformation