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)
• Ph+ CML in CP with the T315I mutation

It is not known if SCEMBLIX is safe and effective in children.

Learn more about SCEMBLIX

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)
• Almost 40% of 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%) in patients treated 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 you to become resistant 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 study among patients with Ph+ CML in chronic phase who have the T315I mutation:

• More than 4 out of 10 patients (out of 45 patients, or 42%) achieved a major molecular response (MMR) with SCEMBLIX by 24 weeks
• Nearly 5 out of 10 patients (out of 45 patients, or 49%) 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

SCEMBLIX is thought to bind to a different site on the BCR-ABL protein than other medications that treat Ph+ CML in chronic phase. Learn more

Take SCEMBLIX every day as prescribed by your doctor. Your doctor will prescribe either the 20 mg or 40 mg 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.

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 routine 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 to check for side effects. Learn about tests your doctor may order

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 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
  • fever
  • 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
  • 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 pain 

• nose, throat, or sinus (upper respiratory tract) infections
• muscle, bone, or joint pain
• headache
• tiredness
• nausea
• rash
• diarrhea
• 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
• increased blood uric acid 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 of 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.

If you have been newly prescribed SCEMBLIX, you may be eligible to receive up to a free 30-day supply, which will allow you to start your prescribed treatment quickly. Program rules may vary. Learn more

You may be eligible for immediate co-pay savings on your next prescription of SCEMBLIX.

• Eligible patients with private insurance may pay $0 per month*
• Novartis will pay the remaining co-pay, up to $15,000 per calendar year, per product*

To find out if you are eligible for the Novartis Oncology Universal Co-pay Program, call 1-877-577-7756 or visit Copay.NovartisOncology.com.

*Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients who are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit Copay.NovartisOncology.com or call 1-877-577-7756.