What are the possible side effects of SCEMBLIX?

SCEMBLIX may cause serious side effects, including:

• ​​​Low blood cell counts: SCEMBLIX may cause low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Your doctor will do blood tests to check your blood cell counts every 2 weeks for the first 3 months of treatment and then monthly or as needed during treatment with SCEMBLIX. Tell your doctor right away if you have unexpected bleeding or easy bruising, blood in your urine or stools, fever, or any signs of an infection

• Pancreas problems: SCEMBLIX may increase enzymes in your blood called amylase and lipase, which may be a sign of inflammation of the pancreas (pancreatitis). Your doctor may do blood tests monthly or as needed during treatment with SCEMBLIX to check for problems with your pancreas. Tell your doctor right away if you have severe stomach-area (abdominal) pain or discomfort, nausea, or vomiting

• High blood pressure: Your doctor may check your blood pressure and treat any high blood pressure during treatment with SCEMBLIX as needed. Tell your doctor if you develop high blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath

• Allergic reaction: Stop taking SCEMBLIX and get medical help right away if you get any signs or symptoms of an allergic reaction, including: 

  • trouble breathing or swallowing 

  • swelling of the face, lips, or tongue 

  • skin rash or flushing of your skin 

  • feeling dizzy or faint 

  • fever 

  • fast heartbeat

• Heart and blood vessel (cardiovascular) problems: SCEMBLIX may cause heart and blood vessel problems, including heart attack, stroke, blood clots or blockage of your arteries, heart failure, and abnormal heartbeat, which can be serious and may sometimes lead to death. In the majority of cases, these heart and blood vessel problems happened in people with risk factors or a history of these problems, and previously treated with other tyrosine kinase inhibitor (TKI) medicines. Your doctor may monitor you for heart and blood vessel problems and treat you as needed during treatment with SCEMBLIX. Tell your doctor or get medical help right away if you get: 

  • shortness of breath 

  • chest pain or pressure 

  • a feeling like your heart is beating too fast or you feel abnormal heartbeats 

  • swelling in your ankles or feet 

  • dizziness 

  • weight gain 

  • numbness or weakness on one side of your body 

  • decreased vision or loss of vision 

  • trouble talking 

  • pain in your arms, legs, back, neck, or jaw 

  • headache 

  • severe stomach-area (abdominal) pain 

The most common side effects of SCEMBLIX include:

• muscle, bone, or joint pain

• rash

• tiredness

• nose, throat, or sinus (upper respiratory tract) infections

• headache

• stomach-area (abdominal) pain

• diarrhea

• decreased white blood cell counts, platelet counts, and red blood cell counts

• decreased blood calcium corrected levels

• increased blood pancreas enzyme (lipase and amylase) levels

• increased blood fat (cholesterol and triglycerides) levels

• increased blood uric acid levels

• increased blood liver enzyme levels

• increased blood alkaline phosphatase levels

• increased blood creatine kinase levels

Your doctor may change your dose, temporarily stop, or permanently stop treatment with SCEMBLIX if you have certain side effects. 
SCEMBLIX may cause fertility problems in females. This may affect your ability to have a child. Talk to your doctor if this is a concern for you. 
These are not all the possible side effects of SCEMBLIX. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.

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