TIBSOVO may cause serious side effects, including:
Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening.
Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:
- weakness or tingling feeling in your legs, arms, or upper body
- numbness and pain on one side or both sides of your body
- any changes in your ability to see, touch, hear, or taste
- burning or prickling sensation
- difficulty breathing
The most common side effects of TIBSOVO in adults with Cholangiocarcinoma include:
- abdominal pain
- decreased appetite
- fluid and swelling in your stomach area
- hemoglobin decreased (anemia)
- changes in liver function tests
Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.
TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before taking TIBSOVO, tell your healthcare provider about all of your medical conditions, including if you:
- have any heart problems, including a condition called long QT syndrome
- have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
- have nervous system problems
- have problems with your kidneys or are on dialysis
- have any liver disorders, including cirrhosis
- are pregnant or plan to become pregnant. TIBSOVO can cause harm to your unborn baby. You should avoid
becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become
pregnant or think you might be pregnant during treatment with TIBSOVO
- are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not
breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.
Please see Full Prescribing Information, including Medication Guide.