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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Iclusig?

Iclusig may cause serious side effects, including:

Blood clots in your blood vessels (arteries and veins). Blood clots in your blood vessels may lead to heart attack, stroke, or death. Get medical help right away if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

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 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:

• yellowing of your skin or the white part of your eyes (jaundice)
• nausea or vomiting
• dark "tea-colored" urine
• sleepiness

What are the possible side effects of Iclusig?

Iclusig may cause serious side effects, including:

• See "What is the most important information I should know about Iclusig?"
• High blood pressure. Your blood pressure should be checked regularly and any high blood pressure should be treated while you are taking Iclusig. Tell your healthcare provider if you get headaches, dizziness, chest pain or shortness of breath.
• Heart problems. Iclusig may cause heart failure, irregular heartbeats, or a heart attack. Get medical help right away if you get chest pain, feel faint, lightheaded, dizzy, short of breath, or feel your heart beating irregularly or fast while taking Iclusig.
• Inflammation of the pancreas (pancreatitis). Symptoms include sudden stomach-area pain, nausea, and vomiting. Your healthcare provider should do blood tests to check for pancreatitis during treatment with Iclusig.
• Severe bleeding. Iclusig can cause bleeding which can be serious and may lead to death. Tell your healthcare provider if you get any signs of bleeding while taking Iclusig including:
  • vomiting blood or if your vomit looks like coffee-grounds
  • pink or brown urine
  • red or black (looks like tar) stools
  • coughing up blood or blood clots
  • unusual bleeding or bruising of your skin
  • menstrual bleeding that is heavier than normal
  • unusual vaginal bleeding
  • nose bleeds that happen often
  • drowsiness or difficulty being awakened
  • confusion
  • headache
  • change in speech
• Low blood cell counts. Iclusig may cause low blood cell counts. Your healthcare provider will check your blood counts regularly during treatment with Iclusig. Tell your healthcare provider right away if you have a fever or any signs of an infection while taking Iclusig.
• Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:
  • kidney failure and the need for dialysis treatment
  • an abnormal heartbeat
  Your healthcare provider may do blood tests to check for TLS.
• Fluid retention. Your body may hold too much fluid (fluid retention). Tell your healthcare provider right away if you get any of these symptoms during treatment with Iclusig:
  • swelling of your hands, ankles, feet, face, or all over your body
  • weight gain
  • shortness of breath and cough
• Possible wound healing problems. If you need to have a surgical procedure, tell your healthcare provider that you are taking Iclusig. You should stop taking Iclusig at least 1 week before any planned surgery.
• A tear in your stomach or intestinal wall (perforation). Tell your healthcare provider right away if you get:
  • severe pain in your stomach-area (abdomen)
  • swelling of the abdomen
  • high fever

The most common side effects of Iclusig include:

• high blood pressure
• skin rash
• stomach-area (abdomen) pain
• tiredness
• headache
• dry skin
• constipation
• fever
• joint pain
• nausea

Tell your healthcare provider if you have any side effect that bothers you or that 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. You may report side effects to the FDA at 1-800-FDA-1088.

For more information, please see the full Prescribing Information and Medication Guide for Iclusig, or ask your doctor or pharmacist.