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Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase is a type of leukemia. It is a cancer of the blood and bone marrow.

A key goal in treating Ph+ CML in chronic phase is reducing the number of leukemic cells in your body. Doctors use medications known as tyrosine kinase inhibitors (TKIs) to reduce the amount of leukemic cells in the blood.

If you are diagnosed with Ph+ CML in chronic phase, it’s important to take your medication as prescribed by your doctor. You’ll also need to go for blood tests so your doctor can see if you are responding to treatment.

If you have concerns about your medication, speak with your doctor. For example, if you are not seeing the results you had expected or if side effects have become unmanageable, don’t keep it to yourself. Your doctor needs to hear from you.

Learn more about Ph+ CML in chronic phase 

SCEMBLIX is a prescription medicine used to treat adults with:

• Newly diagnosed or previously treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP)

  • The approval of SCEMBLIX in patients newly diagnosed is based on a study that measured major molecular response (MMR) rate. There are ongoing studies to confirm the clinical benefit of SCEMBLIX for this use and 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. 

Learn more about SCEMBLIX

All other currently approved tyrosine kinase inhibitors (TKIs) bind to the abnormal BCR-ABL protein at a site known as the ATP binding site to help block the protein's activity. SCEMBLIX targets a different site (myristoyl pocket) of the abnormal BCR-ABL protein to help block the protein's activity. Learn more

There are a few options available to treat Ph+ CML in chronic phase. Tyrosine kinase inhibitors (TKIs) are standard first treatment options. SCEMBLIX is a TKI approved in the treatment of adults with newly diagnosed Ph+ CML-CP. Ask your doctor if SCEMBLIX may be right for you.

Before and after starting treatment for CML, your doctor will typically do lab tests and genetic tests and also examine bone marrow samples.

Some of these tests are typically repeated every 3 months for at least the first year of treatment, although the type of tests done, as well as their frequency and duration, depend on how well the treatment works.

Talk to your doctor about your treatment goals, especially if you aren't sure whether your lab tests show that your treatment is working or not.

Also, tell your doctor about any symptoms and side effects so that you and your doctor can make informed decisions about your treatment plan and decide if SCEMBLIX may be right for you.

If your treatment stopped working, it is important to talk to your doctor and care team about your options. You can learn more about SCEMBLIX by clicking here and asking your doctor if SCEMBLIX may be right for you.

Take SCEMBLIX every day exactly as prescribed by your doctor. Do not change your dose or schedule or stop taking SCEMBLIX unless your healthcare provider tells you to. SCEMBLIX comes in either 20-mg, 40-mg, or 100-mg oral tablets. Your doctor will tell you how many times a day to take SCEMBLIX. Swallow SCEMBLIX tablets whole. Do not break, crush, or chew SCEMBLIX tablets.

Do NOT take SCEMBLIX with food. One of the most important things to know about SCEMBLIX is that it should never be taken with food. 

Do not eat for at least 2 hours before and 1 hour after you take SCEMBLIX. 

If you take SCEMBLIX 1 time a day and miss a dose by more than 12 hours, skip the missed dose and take your next dose at your regular time.

If you take SCEMBLIX 2 times a day and miss a dose by more than 6 hours, skip the missed dose and take your next dose at your regular time.

It’s important to take SCEMBLIX on an empty stomach because food may change the way your body absorbs SCEMBLIX. If the medication is taken with food, it can decrease the amount of SCEMBLIX in your blood in an unpredictable way. 

If you need help establishing a dosing routing for SCEMBLIX, ask your doctor for a SCEMBLIX Starter Kit, which includes a dosing wheel. You can use this simple tool to help you create a schedule that works with your mealtimes and your medication. 

Learn more about taking SCEMBLIX 

Once you start on SCEMBLIX, your doctor will have you go for regular blood tests. This includes having your blood counts checked every 2 weeks for the first 3 months you are on treatment and monthly after that. These tests will help your doctor see if you are responding to treatment with SCEMBLIX, as well as check for side effects. 
Learn about monitoring Ph+ CML-CP

• Complete blood count (CBC): The CBC with differential and chemistry profile counts the number of red blood cells, white blood cells, and platelets in the blood

• Standard cytogenetic test: Using a small sample of your bone marrow, this test measures the number of cells with the Ph chromosome

• Fluorescence in situ hybridization (FISH) test: This test uses fluorescent dyes and a microscope to measure the number of cells with the Ph chromosome. Your doctor may order this test because a standard cytogenetic test may not be able to detect all the leukemic cells in the blood

• Quantitative polymerase chain reaction (qPCR or molecular) test: qPCR testing is sensitive enough to detect even the smallest amount of leukemic cells in the blood and bone marrow. Be sure to confirm with your doctor's office that you are referred to a lab that uses a standardized scale, called the International Scale, to measure your BCR::ABL1 level

• BCR::ABL1 kinase domain mutation analysis: This test is used to look for mutations in the BCR::ABL1 gene, which may cause certain medications to stop working. Your doctor will order this test to determine if you have the T315I gene mutation. Learn about SCEMBLIX for Ph+ CML in chronic phase with the T315I mutation

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 these 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.

In a clinical study among those who were previously treated with 2 or more TKIs for Ph+ CML in chronic phase:  

• Nearly twice as many patients achieved a major molecular response (MMR) with SCEMBLIX at 24 weeks than with Bosulif (bosutinib).* The results were 25% for SCEMBLIX (40 of 157 patients) vs 13% for Bosulif (10 of 76 patients)  

• More than twice as many patients achieved MMR with SCEMBLIX at nearly 2 years (96 weeks) than with Bosulif. The results were 38% for SCEMBLIX (59 of 157 patients) vs 16% for Bosulif (12 of 76 patients)

In this clinical trial, the most common side effects reported (≥ 20%) with SCEMBLIX were nose/throat infections; pain in the muscles, bones, or joints; headache; and tiredness.

If you’ve previously taken 2 or more TKIs for Ph+ CML in chronic phase and haven’t seen the results you had expected, ask your doctor if SCEMBLIX may be right for you. Learn more about SCEMBLIX. 

*Bosulif is a registered trademark of Pfizer Inc.

When you have Ph+ CML in chronic phase, a gene mutation may develop that stops certain tyrosine kinase inhibitors (TKIs) from working. Your doctor may want you to be tested for a mutation if you:  

• Do not respond to a medication 

• Stop responding to a medication

• Cannot reach a treatment milestone 

If this sounds like what you’ve been going through, ask your doctor if you should be tested for a mutation. A test known as a BCR::ABL1 kinase domain mutation analysis can identify mutations in the BCR::ABL1 gene that may cause your cancer to stop responding to certain TKIs. One of these mutations is called the T315I gene mutation. Learn more about mutations

Ask your doctor if SCEMBLIX may be right for you. 

In a clinical trial among patients with Ph+ CML in chronic phase who have the T315I mutation, more than 4 out of 10 patients (19 out of 45 patients or 42%) with the T315I mutation achieved a major molecular response (MMR) with SCEMBLIX by 24 weeks. 49% of patients (22 out of 45 patients) achieved MMR by 96 weeks.

In this clinical trial, the most common side effects reported (≥ 20%) were pain in muscles, bones, or joints; tiredness; nausea; rash; and diarrhea. 

Learn about SCEMBLIX for the T315I mutation

Once you’ve been prescribed SCEMBLIX, you or your loved one can sign up for Novartis Patient Support. You’ll have a go-to team member who will reach out from the start and get to know you. When you have questions, you can talk to them directly.* Learn more

And once your health care provider has filed the paperwork with your insurance, Novartis Patient Support can help with the rest.

*Novartis Patient Support does not provide clinical advice and is not a substitute for consulting with your health care provider.

Click here to download the SCEMBLIX Patient Brochure, Doctor Discussion Guide, and more.