Informational only — Not medical advice. Always consult a licensed healthcare provider.

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Community data Updated 22 hours ago
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Indications

Cancer

Newly-diagnosed acute myeloid leukemia Ivosidenib is used to treat newly-diagnosed acute myeloid leukemia (AML) in adults who have a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA approved test. It is for patients who are 75 years or older, or who have other health conditions that rule out intensive induction chemotherapy. Relapsed or refractory acute myeloid leukemia Ivosidenib is also used in adults whose acute myeloid leukemia (AML) has relapsed or has not responded to treatment (refractory), when the leukemia has a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. Locally advanced or metastatic cholangiocarcinoma In adults with cholangiocarcinoma that is locally advanced or metastatic, and that has already been treated before, ivosidenib is used when an isocitrate dehydrogenase-1 (IDH1) mutation is found by an FDA-approved test.

⚠️ Always consult a registered physician before taking any medicine.

Pregnancy & Breastfeeding

Pregnancy

Animal studies on embryo-fetal toxicity suggest that Ivosidenib may cause harm to the baby if a pregnant woman takes it. There are no data on its use in pregnant women, so the risk of major birth defects and miscarriage is not known. In the animal studies, pregnant rats and rabbits were given Ivosidenib by mouth during organogenesis. This was linked with embryo-fetal mortality and changes in growth, starting at 2 times the steady state clinical exposure, based on the AUC at the recommended human dose. If Ivosidenib is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be told about the possible risk to the fetus.

Lactation

Nobody knows yet whether Ivosidenib or its metabolites pass into human milk, what effect they might have on a breastfed child, or whether they change milk production. Many drugs are excreted in human milk, and breastfed children could have adverse reactions, so women are advised not to breastfeed during treatment with Ivosidenib and for at least 1 month after the last dose.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Acute Myeloid Leukemia: Choose patients for Ivosidenib treatment of AML based on whether IDH1 mutations are present in the blood or bone marrow. If a patient with AML had no IDH1 mutation at diagnosis, test again at relapse, because an IDH1 mutation may appear during treatment and at relapse. Locally Advanced or Metastatic Cholangiocarcinoma: Choose patients for Ivosidenib treatment of locally advanced or metastatic cholangiocarcinoma based on whether IDH1 mutations are present. Recommended Dosage: The recommended dose of Ivosidenib is 500 mg taken orally once daily, continuing until the disease progresses or the toxicity becomes unacceptable. Ivosidenib can be taken with or without food, but not with a high-fat meal, because that causes an increase in Ivosidenib. Don't split or crush the tablets. Give them by mouth at about the same time each day. If a dose is vomited, don't give a replacement dose. Wait until the next scheduled dose is due. If a dose is missed or not taken at the usual time, give it as soon as possible, and at least 12 hours before the next scheduled dose. Then go back to the normal schedule the next day. Never give 2 doses within 12 hours. Patients with Acute Myeloid Leukemia: If there is no disease progression or unacceptable toxicity, treat for a minimum of 6 months, so there is time for a clinical response. Patients with the Comorbidities of Severe Renal or Severe Hepatic Impairment: Ivosidenib has not been studied in patients who already have severe renal or hepatic impairment. For these patients, consider the risks and the potential benefits before starting treatment with Ivosidenib.

Side Effects & Interactions

Side Effects

No side-effect data recorded yet.