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 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.
uses
What isIvosidenib (Tibsovo)used for?
- Acute Myeloid Leukemia
warnings
What is the most important information I should know aboutIvosidenib (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;
- 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 this medicine.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.
Side Effects
What are the side effects ofIvosidenib (Tibsovo)?
Get emergency medical help if you havesigns 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 havesymptoms of differentiation syndrome:
- fever, cough, trouble breathing;
- dizziness;
- rash;
- decreased urination;
- rapid weight gain; or
- swelling in your arms or legs.
马上打电话给你的医生如果你有:
- 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)——白皮肤、疲劳、头晕或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 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.
Pregnancy & Breastfeeding
Can I takeIvosidenib (Tibsovo)if I’m pregnant or breastfeeding?
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.
Do not breastfeed while using ivosidenib,and for at least 1 month after your last dose.
Interactions
What drugs and food should I avoid while takingIvosidenib (Tibsovo)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to takeIvosidenib (Tibsovo)?
UseIvosidenib (Tibsovo)exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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.
Do not change your dose or stop taking ivosidenib without your doctor's advice.
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. Take your next dose as scheduled.
You may need medical tests to check your heart function.
Store at room temperature away from moisture and heat.
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 nottake two doses within 12 hours.
Overdose Signs
What happens if I overdose onIvosidenib (Tibsovo)?
Images
IVO, 250
Color: blue
Shape: oval
Form: film coated
Imprint: IVO, 250