Tibsovo
- Generic Name: ivosidenib tablets
- Brand Name: Tibsovo
- Drug Class: IDH1 Inhibitors
side effects drug center tibsovo (ivosidenib tablets) drug - patient side effects and images
Tibsovo Patient Information Including Side Effects
Brand Names: Tibsovo
Generic Name: ivosidenib
- What is ivosidenib (Tibsovo)?
- What are the possible side effects of ivosidenib (Tibsovo)?
- What is the most important information I should know about ivosidenib (Tibsovo)?
- What should I discuss with my healthcare provider before taking ivosidenib (Tibsovo)?
- How should I take ivosidenib (Tibsovo)?
- What happens if I miss a dose (Tibsovo)?
- What happens if I overdose (Tibsovo)?
- What should I avoid while taking ivosidenib (Tibsovo)?
- What other drugs will affect ivosidenib (Tibsovo)?
- Where can I get more information (Tibsovo)?
What is ivosidenib (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).
Ivosidenib 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.
Ivosidenib is also used in adults 75 years and older who have newly-diagnosed AML and cannot use certain chemotherapy treatments because of other health problems.
Ivosidenib may also be used for purposes not listed in this medication guide.
What are the possible side effects of ivosidenib (Tibsovo)?
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.
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 side effects may 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 is the most important information I should know about ivosidenib (Tibsovo)?
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 should I discuss with my healthcare provider before taking ivosidenib (Tibsovo)?
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; 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.
Ivosidenib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using ivosidenib, 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 ivosidenib (Tibsovo)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
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 ivosidenib.
Do not take ivosidenib with foods that are high in fat, such as butter, bacon, cheese, or whole milk.
If you vomit shortly after taking ivosidenib, 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.
Tibsovo Patient Information including If I Miss a Dose
What happens if I miss a dose (Tibsovo)?
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 (Tibsovo)?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking ivosidenib (Tibsovo)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect ivosidenib (Tibsovo)?
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 your current medicines and any medicine you start or stop using.
Where can I get more information (Tibsovo)?
Your pharmacist can provide more information about ivosidenib.
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