Important Safety Information and Approved Uses
APPROVED USES for SCEMBLIX® (asciminib) Tablets
SCEMBLIX is a prescription medicine used to treat adults with:
- Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
- The effectiveness of SCEMBLIX in patients previously treated with 2 or more TKIs is based on a study that measured major molecular response (MMR) rates. No clinical information is available to show if these patients treated with SCEMBLIX live longer or if their symptoms improve. Ongoing studies exist to find out how SCEMBLIX works over a longer period of time.
- Ph+ CML in CP with the T315I mutation
It is not known if SCEMBLIX is safe and effective in children.
IMPORTANT SAFETY INFORMATION for SCEMBLIX® (asciminib) Tablets
Before taking SCEMBLIX, tell your doctor about all your medical conditions, including if you:
- have a history of inflammation of your pancreas (pancreatitis)
- have a history of heart problems or blood clots in your arteries and veins (types of blood vessels)
- are pregnant or plan to become pregnant. SCEMBLIX can harm your unborn baby
- Your doctor will do a pregnancy test before you start treatment with SCEMBLIX
- Females who are able to become pregnant should use effective birth control during treatment and for 1 week after your last dose of SCEMBLIX. Talk to your doctor about birth control methods that may be right for you
- Tell your doctor right away if you become pregnant or think you may be pregnant during treatment with SCEMBLIX
- are breastfeeding or plan to breastfeed. It is not known if SCEMBLIX passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of SCEMBLIX
Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SCEMBLIX and other medicines may affect each other and cause side effects.
SCEMBLIX may cause serious side effects, including:
The most common side effects of SCEMBLIX include:
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 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 sudden stomach-area 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 elevated 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
- fast heartbeat
Heart and blood vessel (cardiovascular) problems: SCEMBLIX may cause heart and blood vessel problems, including heart attack, stroke, blood clots, blockage of your arteries, heart failure, and abnormal heartbeat, which can be serious and may sometimes lead to death. These heart and blood vessel problems can happen in people with risk factors or a history of these problems, and/or previously treated with other 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
- 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
- severe stomach-area pain
- nose, throat, or sinus (upper respiratory tract) infections
- muscle, bone, or joint pain
- decreased blood platelet counts, white blood cell counts, and red blood cell counts
- increased blood fat (triglycerides) levels
- increased blood creatine kinase levels
- increased blood liver enzyme levels
- increased blood pancreas enzyme (amylase and lipase) 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.
Please click here for full Prescribing Information, including Patient Information.