Generic Name: ivosidenib (EYE voe SID e nib)
Brand Name: Tibsovo
Drug class: Miscellaneous antineoplastics
Tibsovo (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).
Tibsovo is used to treat AML in adults with an IDH1 mutation. Your doctor will test you for this gene. Ivosidenib is used when other treatments did not work or have stopped working.
Tibsovo is used in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems.
Tibsovo is also used to treat bile duct cancer (cholangiocarcinoma) in adults with an IDH1 mutation. Ivosidenib is used when other treatments did not work or have stopped working.
Warnings
Tibsovo can cause a condition called differentiation syndrome in AML patients, 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.
Before taking this medicine
You should not use Tibsovo if you are allergic to ivosidenib.
To make sure Tibsovo is safe for you, tell your doctor if you have ever had:
- heart disease;
- long QT syndrome (in you or a family member);
- nerve problems; or
- an electrolyte imbalance (such as low levels of potassium, sodium, or magnesium in your blood).
Ivosidenib may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.
Tibsovo can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Tibsovo, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.
This medicine may affect fertility (ability to have children) in both men and women. However, women should still use birth control to prevent pregnancy because ivosidenib can harm an unborn baby.
Do not breastfeed while using this medicine, and for at least 1 month after your last dose.
How should I take Tibsovo?
Take Tibsovo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Swallow the tablet whole and do not crush, chew, or break it.
Take the medicine at the same time each day, with or without food.
Drink plenty of liquids while you are taking Tibsovo.
Do not take Tibsovo with foods that are high in fat, such as butter, bacon, cheese, or whole milk.
If you vomit shortly after taking Tibsovo, do not take another dose. Wait until your next scheduled dose time to take the medicine again.
Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Acute Myeloid Leukemia:
500 mg 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
Comments:
-NOTE: Select patients for the treatment of AML 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 therapy and at relapse.
Use: 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
Usual Geriatric Dose for Acute Myeloid Leukemia:
75 years or older:
500 mg 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
Comments:
-NOTE: Select patients for the treatment of AML 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 therapy and at relapse.
Use: For the treatment of adult patients with newly-diagnosed AML with a susceptible IDH1 mutation as detected by an FDA-approved test who are 75 years older or who have comorbidities that preclude use of intensive induction chemotherapy.
Usual Adult Dose for Cholangiocarcinoma
500 mg orally once daily until disease progression or unacceptable toxicity
Use: For the treatment of adult patients with previously treated locally advanced or metastatic cholangiocarcinoma who have a susceptible IDH1 mutation as detected by an FDA-approved test.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Tibsovo side effects
Get emergency medical help if you have signs of an allergic reaction to Tibsovo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tibsovo 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 Tibsovo.
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.
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);
- low red blood cell counts (anemia) - pale skin, unusual tiredness, feeling light-headed, cold hands and feet;
- high white blood cell counts - fever, weakness, not feeling well, bleeding or bruising, dizziness, sweating, pain or tingling, loss of appetite, weight loss, problems with vision or thinking, trouble breathing; or
- nervous system problems - numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.
Common Tibsovo side effects include:
- irregular heartbeats;
- nausea, 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;
- 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.
What other drugs will affect Tibsovo?
Tibsovo 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 interact with ivosidenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.