You may experience side effects when taking TIBSOVO
Whether you are taking TIBSOVO for acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or cholangiocarcinoma (CCA), always tell your doctor about any side effects you experience.
TIBSOVO may cause serious side effects, including differentiation syndrome.
Differentiation syndrome
Blood cells form through a process called differentiation. Cell differentiation is the process where young, generic cells mature and change into specific types of cells, such as blood cells. Some treatments for AML, including TIBSOVO, can cause cellular differentiation to happen too fast. This is called differentiation syndrome.
- In the clinical study, about 15% of people with newly diagnosed AML who took TIBSOVO in combination with azacitidine (11 out of 71) experienced differentiation syndrome
- In the clinical study, 25% of people with newly diagnosed AML who took TIBSOVO alone (1 out of 4) experienced differentiation syndrome
- In the clinical study, about 19% of people with relapsed or refractory AML who took TIBSOVO alone (34 out of 179) experienced differentiation syndrome
Contact your healthcare provider right away if you have any of the following symptoms of differentiation syndrome:
-
Fever -
Cough -
Trouble breathing -
Rash -
Decreased
urination -
Dizziness or
lightheadedness -
Rapid
weight gain -
Swelling of your
arms or legs
If you have differentiation syndrome, your healthcare provider may give you steroids or other medications and monitor you in the hospital.
It is important to let all of your healthcare providers know that you are taking a medication that can cause differentiation syndrome. The Differentiation Syndrome Reference Card can help. Print out the card, fill it out, and keep it with you at all times. Be sure to show it to any person involved in your medical care.
TIBSOVO may cause other 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) before and 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
- Changes in certain blood cell counts
- Diarrhea
- Increased blood sugar
- Fatigue
- Changes in certain liver function tests
- Swelling of arms or legs
- Decreased levels of electrolytes in the blood
- Nausea
- Vomiting
- 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
- Rash
- Irregular heart rhythm or heartbeat (QTc prolongation)
- Differentiation syndrome
- Muscle pain
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 www.fda.gov/medwatch.
TIBSOVO may cause serious side effects, including differentiation syndrome.
Differentiation syndrome
Blood cells form through a process called differentiation. Cell differentiation is the process where young, generic cells mature and change into specific types of cells, such as blood cells. Some treatments for MDS, including TIBSOVO, can cause cellular differentiation to happen too fast. This is called differentiation syndrome.
- In the clinical study, about 11% of people with relapsed or refractory MDS who took TIBSOVO experienced differentiation syndrome
Contact your healthcare provider right away if you have any of the following symptoms of differentiation syndrome:
-
Fever
-
Cough
-
Trouble breathing
-
Rash
-
Decreased
urination -
Dizziness or
lightheadedness -
Rapid
weight gain -
Swelling of your
arms or legs
If you have differentiation syndrome, your healthcare provider may give you steroids or other medications and monitor you in the hospital.
It is important to let all of your healthcare providers know that you are taking a medication that can cause differentiation syndrome. The Differentiation Syndrome Reference Card can help. Print out the card, fill it out, and keep it with you at all times. Be sure to show it to any person involved in your medical care.
TIBSOVO may cause other 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) before and 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
- Changes in certain kidney function tests
- Changes in certain blood cell counts
- Joint pain, back pain, or neck pain
- Decreased levels of albumin in the blood
- Changes in liver function tests
- Fatigue
- Diarrhea
- Cough
- Decreased levels of sodium in the blood
- Pain or sores in your mouth or throat
- Decreased appetite
- Muscle pain
- Decreased levels of phosphorus in the blood
- Itchy skin
- Rash
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 (U.S. Food & Drug Administration) at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.
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) before and 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
- Fatigue
- Nausea
- Abdominal pain
- Diarrhea
- Cough
- Hemoglobin decreased (anemia)
- Decreased appetite
- Fluid and swelling in your stomach area
- Vomiting
- Changes in liver function tests
- Rash
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 www.fda.gov/medwatch.