Pricing
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All price changes →Indications & Uses
Ivosenib is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist 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
Ivosidenib can cause several serious reactions that are covered in more detail in other sections of the labeling. These are differentiation syndrome in AML, QTc interval prolongation and Guillain-Barré syndrome. Other signs to watch for are fever, cough, trouble breathing, rash, decreased urination, dizziness or lightheadedness, rapid weight gain, and swelling of your arms or legs.
Cautions & Contraindications
Warnings & Precautions
Differentiation Syndrome in AML: In the clinical trial, 25% (7/28) of patients with newly diagnosed AML and 19% (34/179) of patients with relapsed or refractory AML who took Ivosidenib developed differentiation syndrome. The syndrome is linked with rapid growth and differentiation of myeloid cells. If it isn't treated, it may be life-threatening or fatal. In patients on Ivosidenib, the symptoms included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumorlysis syndrome and creatinine increased. Of the 7 patients with newly diagnosed AML who had differentiation syndrome, 6 (86%) recovered. Of the 34 patients with relapsed or refractory AML who had it, 27 (79%) recovered after treatment or after Ivosidenib was interrupted. Differentiation syndrome appeared as early as 1 day and up to 3 months after Ivosidenib was started, and it has been seen with or without concomitant leukocytosis. QTc Interval Prolongation: Ivosidenib can cause QT (QTc) prolongation and ventricular arrhythmias. In the clinical trial (AG120-C-001), 258 patients with hematological malignancies were treated. Of these, 9% had a QTc interval greater than 500 msec and 14% had a rise from baseline QTc of more than 60 msec. One patient developed ventricular fibrillation that was attributed to Ivosidenib. The trial left out patients with a baseline QTc of ≥ 450 msec (unless the QTc ≥ 450 msec was due to a pre-existing bundle branch block). It also left out patients with a history of long QT syndrome or with uncontrolled or significant cardiovascular disease. Guillain-Barré Syndrome: Patients taking Ivosidenib can develop Guillain-Barré syndrome. In study AG120-C-001 it occurred in <1% (2/258) of patients. Patients should be monitored for new signs or symptoms of motor and/or sensory neuropathy, such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. If Guillain-Barré syndrome is diagnosed, Ivosidenib must be stopped permanently.
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.
Use in Special Populations
Pediatric use: Ivosidenib has not been shown to be safe or effective in pediatric patients.
Geriatric use: Patients aged 65 years and older did not differ from younger patients in how well Ivosidenib worked or in its safety.
Storage
Keep Ivosidenib below 30°C, in a cool and dry place, and away from light. Keep it out of the reach of children.
Drug Interactions
Common questions about Ivosenib 250 mg
What is Ivosenib 250 mg Tablet?
Ivosenib 250 mg Tablet is a medicine that contains Ivosidenib. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Ivosenib used for?
Ivosenib is used for: Cancer.
What are the side effects of Ivosenib?
Ivosidenib can cause several serious reactions that are covered in more detail in other sections of the labeling. These are differentiation syndrome in AML, QTc interval prolongation and Guillain-Barré syndrome.
Can I take Ivosenib during pregnancy or while 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. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Ivosenib?
Keep Ivosidenib below 30°C, in a cool and dry place, and away from light. Keep it out of the reach of children.
Can I take other medicines with Ivosenib?
Some medicines can interact with Ivosidenib, for example: Itraconazole, Rifampicin. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Ivosenib is already among the lowest-priced brands of Ivosidenib at this strength.
Do I need a prescription for Ivosenib?
Ivosenib is a prescription (Rx) medicine. Take it as your doctor advises.