TIBSOVO may cause serious side effects, including:
Differentiation Syndrome in AML Patients. Differentiation syndrome is a serious condition that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with acute myeloid leukemia (AML) has
happened as early as 1 day and up to 3 months after starting TIBSOVO. Call your healthcare provider or go to the nearest
hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment
- trouble breathing
- decreased urination
- dizziness or lightheadedness
- rapid weight gain
- swelling of your arms and legs
If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital
- 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.
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 when used in combination with azacitidine or alone in adults with AML include:
- changes in certain blood cell counts
- increased blood sugar
- changes in certain liver function tests
- swelling of arms or legs
- decreased levels of electrolytes in the blood
- decreased appetite
- joint pain
- shortness of breath
- uric acid increased
- stomach (abdominal) pain
- changes in certain kidney function tests
- pain or sores in your mouth or throat
- irregular heart rhythm or heartbeat (QTc prolongation)
- differentiation syndrome
- muscle pain
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 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 of 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 .
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 , including BOXED
WARNING for AML patients and .