Ivosidenib

Generic name: Ivosidenib
Brand names: Tibsovo
Dosage form: oral tablet (250 mg)
Drug class: Miscellaneous antineoplastics

Usage of Ivosidenib

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.

Ivosidenib side effects

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

    • Ivosidenib may cause serious side effects. Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, sudden dizziness (like you might pass out);
  • jaundice (yellowing of the skin or eyes);
  • fluid build-up around the stomach--rapid weight gain, stomach pain and bloating, trouble breathing while lying down;
  • low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet;
  • high white blood cell counts--fever, weakness, not feeling well, bleeding or bruising, nausea, loss of appetite, weight loss; or
  • nervous system problems--numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

    • Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

    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; or
  • swelling 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. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Ivosidenib

    You should not use ivosidenib if you are allergic to it.

    Tell your doctor if you have ever had:

  • heart disease;
  • long QT syndrome (in you or a family member);
  • nerve problems;
  • an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood);
  • cirrhosis or other liver disease; or
  • kidney disease (or if you are on dialysis).

    • May harm an unborn baby. Use birth control and tell your doctor if you become pregnant.

    Ivosidenib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

    Pregnancy may be less likely to occur while the mother or the father is using ivosidenib. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

    Do not breastfeed while using ivosidenib, and for at least 1 month after your last dose.

    Relate drugs

    How to use Ivosidenib

    Usual Adult Dose for Acute Myeloid Leukemia:

    500 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityComments:-For patients without disease progression or unacceptable toxicity, therapy should continue for at least 6 months to allow time for clinical response.-Combination regimen: Administration of this drug should start on Cycle 1 Day 1 in combination with azacitidine; the manufacturer product information for azacitidine should be consulted.Uses:-In combination with azacitidine or as monotherapy, for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by a US FDA-approved test in patients 75 years and older or who have comorbidities that preclude use of intensive induction chemotherapy-For the treatment of patients with relapsed or refractory AML with a susceptible IDH1 mutation as detected by a US FDA-approved test

    Usual Adult Dose for Cholangiocarcinoma of biliary tract:

    500 mg orally once a dayDuration of therapy: Until disease progression or unacceptable toxicityUse: For the treatment of patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by a US FDA-approved test

    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.

    What other drugs will affect Ivosidenib

    Ivosidenib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

    Other drugs may affect ivosidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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