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ICLUSIG can cause serious side effects, including: Blood clots or blockage in your blood vessels (arteries and veins). Blood clots or blockage in your blood vessels may lead to heart attack, stroke, or death. You may need emergency surgery or treatment in a hospital. Heart problems. ICLUSIG can cause heart problems, including heart failure, which can be serious and may lead to death. Liver problems. ICLUSIG can cause liver problems, including liver failure, which can be severe and may lead to death.
ICLUSIG can cause serious side effects, including:
Blood clots or blockage in your blood vessels (arteries and veins). Blood clots or blockage in your blood vessels may lead to heart attack, stroke, or death. A blood clot or blockage in your blood vessels can prevent proper blood flow to your heart, brain, bowels (intestines), legs, eyes, and other parts of your body. You may need emergency surgery or treatment in a hospital. Get medical help right away if you get any of the following symptoms:
Blood clots or blockage in your blood vessels can happen in people with or without risk factors for heart and blood vessel disease, including people 50 years of age or younger. The most common risk factors for these problems are a history of high blood pressure (hypertension), high cholesterol, and heart disease. Blood clots or blockages in your blood vessels happen more often in people as they get older, and in people with a history of decreased blood flow, high blood pressure, diabetes, or high cholesterol.
Heart problems. ICLUSIG can cause heart problems, including heart failure which can be serious and may lead to death. Heart failure means your heart does not pump blood well enough. ICLUSIG can also cause irregular, slow, or fast heartbeats and heart attack. Your healthcare provider will check you for heart problems during your treatment with ICLUSIG. Get medical help right away if you get any of the following symptoms: shortness of breath, chest pain, fast or irregular heartbeats, dizziness, or feel faint.
Liver problems. ICLUSIG can cause liver problems, including liver failure, which can be severe and may lead to death. Your healthcare provider will do blood tests before and during your treatment with ICLUSIG to check for liver problems. Get medical help right away if you get any of these symptoms of liver problems during treatment:
See "What are the possible side effects of ICLUSIG?" for information about side effects.
Before you take ICLUSIG, tell your healthcare provider about all of your medical conditions, including if you:
Do not breastfeed during treatment and for 1 week after your last dose of ICLUSIG.
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. ICLUSIG and other medicines may affect each other causing side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ICLUSIG?
What are the possible side effects of ICLUSIG?
ICLUSIG may cause serious side effects, including:
The most common side effects of ICLUSIG when given alone include:
The most common side effects of ICLUSIG when given with chemotherapy include:
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with ICLUSIG if you have certain side effects.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of ICLUSIG. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
To report SUSPECTED SIDE EFFECTS, contact Takeda at 1-844-817-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the Medication Guide for ICLUSIG and discuss it with your doctor. For additional information, please see the full Prescribing Information including Boxed Warning.
ICLUSIG is a prescription medicine used to treat adults who have:
ICLUSIG is not for use to treat people with newly diagnosed chronic phase CML.
It is not known if ICLUSIG is safe and effective in children.
*ICLUSIG in combination with chemotherapy in newly diagnosed adult patients with Ph+ ALL was approved based on patient responses at 3 months of therapy. There is an ongoing study to confirm results.