Ivosidenib Tablets Ivosidenib works to stop cancer cells from growing to treat acute myelogenous leukemia and cholangiocarcinoma. This medication comes in a tablet form. You can take it by mouth as directed. If this medication upsets your stomach, take it with food.

Ivosenib 250mg (Ivosidenib)

Newly-Diagnosed Acute Myeloid Leukemia:

Ivosenib 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:

Ivosenib 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.

Locally Advanced or Metastatic Cholangiocarcinoma:

Ivosenib is indicated for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Category: Blood cancer Brand: Everest Pharmaceuticals Ltd.

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Description
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Ivosidenib targets a specific gene mutation called IDH1, which can affect your bone marrow. IDH1 mutation prevents young blood cells from developing into healthy adult blood cells, which can result in symptoms of

acute myeloid leukemia (AML). Ivosidenib is for use only in adults with an IDH1 mutation. Your doctor will test you for this gene.

Ivosidenib is used to treat AML after other treatments did not work or stopped working.

Ivosidenib is also used to treat AML in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems.

Ivosidenib is also used to treat bile duct cancer that has progressed or has spread to other parts of the body (metastatic) after treatment with other medicine.

Ivosidenib may also be used for purposes not listed in this medication guide.

They need to know if you have any of these conditions:

Guillain-Barre syndrome
Heart disease
Irregular heartbeat or rhythm
Kidney disease
Liver disease
Low levels of sodium, potassium, or magnesium in the blood
Nervous system problems
An unusual or allergic reaction to ivosidenib, other medications, foods, dyes, or preservatives
Pregnant or trying to get pregnant
Breastfeeding

Ivosidenib side effects:

Get emergency medical help if you have signs of an allergic reaction:

Difficult breathing; swelling of your face, lips, tongue, or throat.

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib .

Seek medical help right away if you have symptoms of differentiation syndrome:

fever, cough, trouble breathing;
dizziness;
rash;
decreased urination;
rapid weight gain; or
swelling in your arms or legs.

Common side effects of ivosidenib may include:

irregular heartbeats;
stomach pain or swelling, nausea, vomiting, loss of appetite;
diarrhea, constipation; fever, tiredness;
low red blood cell or high white blood cell counts;
cough, shortness of breath;
sores in your mouth or throat;
rash;
abnormal liver function tests;
muscle or joint pain; orswelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects

Warnings:

Ivosidenib can cause a condition called differentiation syndrome, which affects blood cells and can be fatal if not treated. This condition may occur within 1 days to 3 months after you start taking ivosidenib.

Seek medical help right away if you have symptoms of differentiation syndrome: fever, dizziness, cough, trouble breathing, swelling, rapid weight gain, rash, or decreased urination.

Pregnancy & Lactation

Pregnancy: Based on animal embryo-fetal toxicity studies, Ivosidenib may cause fetal harm when administered to a pregnant woman. There are no available data on Ivosidenib use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In animal embryo-fetal toxicity studies, oral administration of Ivosidenib to pregnant rats and rabbits during organogenesis was associated with embryo-fetal mortality and alterations to growth starting at 2 times the steady state clinical exposure based on the AUC at the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.

Lactation: There are no data on the presence of Ivosidenib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with Ivosidenib and for at least 1 month after the last dose.

Precautions & Warnings:

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 treated with Ivosenib experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with Ivosenib 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 experienced differentiation syndrome, 6 (86%) patients recovered. Of the 34 patients with relapsed or refractory AML who experienced differentiation syndrome, 27 (79%) patients recovered after treatment or after dose interruption of Ivosenib. Differentiation syndrome occurred as early as 1 day and up to 3 months after Ivosenib initiation and has been observed with or without concomitant leukocytosis.

QTc Interval Prolongation: Patients treated with Ivosenib can develop QT (QTc) prolongation and ventricular arrhythmias. Of the 258 patients with hematological malignancies treated with Ivosenib in the clinical trial (AG120-C-001), 9% were found to have a QTc interval greater than 500 msec and 14% of patients had an increase from baseline QTc greater than 60 msec. One patient developed ventricular fibrillation attributed to Ivosenib. The clinical trial excluded patients with baseline QTc of ≥ 450 msec (unless the QTc ≥ 450 msec was due to a pre-existing bundle branch block) or with a history of long QT syndrome or uncontrolled or significant cardiovascular disease.

Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with Ivosenib. Guillain-Barré syndrome occurred in <1% (2/258) of patients treated with Ivosenib in study AG120-C-001. Monitor patients taking Ivosenib for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue Ivosenib in patients who are diagnosed with Guillain-Barré syndrome.

Use in Special Populations:

Pediatric Use: The safety and effectiveness of Ivosenib in pediatric patients have not been established.

Geriatric Use: No overall differences in effectiveness or safety were observed between patients who were 65 years and older compared to younger patients.

Therapeutic Class:

Cytotoxic Chemotherapy

Storage Conditions:

Store below 30°C, in a cool and dry place. Keep away from light. Keep out of the reach of children.

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