Some people with Ph+ CML in chronic phase develop a gene mutation known as T315I. This mutation can cause resistance to some medications. 

Only your doctor can determine if you have the T315I mutation through a specific test. If it turns out that you have the T315I mutation, SCEMBLIX may be right for you.

Testing can identify if you have a gene mutation   If you’re not responding to your current medication for Ph+ CML in chronic phase, you may want to ask your doctor if you should be tested for what’s called a gene mutation.   A gene mutation is a change in a cell’s DNA. With Ph+ CML in chronic phase, a mutation may develop that prevents certain tyrosine kinase inhibitors (TKIs) from working. One of these mutations is called the T315I gene mutation.

How will your doctor determine whether you have the T315I mutation?

To find out if you have the T315I mutation, your doctor will need to order a test called the BCR::ABL1 kinase domain mutation analysis. This test can identify mutations in the BCR::ABL1 gene that may cause you to become resistant to certain medications that treat Ph+ CML in chronic phase.
Your doctor may decide to have you tested for a gene mutation if you are:

• Not responding or no longer responding to a medication

• Unable to reach a certain treatment milestone

Results of a clinical trial

SCEMBLIX was studied among patients with Ph+ CML in chronic phase who have the T315I mutation. In a clinical trial:

• 42% of patients (out of 45 patients) with the T315I mutation achieved a major molecular response (MMR) by 24 weeks

• 49% of patients (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.

Ask your doctor about SCEMBLIX   If you’re not responding to your current medication for Ph+ CML in chronic phase, be sure to speak up and ask your doctor whether you should be tested for a gene mutation. If testing shows that you have the T315I mutation, you and your doctor should discuss if SCEMBLIX may be right for you. To help get the conversation started, download the Doctor Discussion Guide.   Download Doctor Discussion Guide

Common side effects of SCEMBLIX

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. 
Review the serious and most common side effects of SCEMBLIX here.

Take SCEMBLIX exactly as prescribed

If your doctor prescribes SCEMBLIX because you have Ph+ CML in chronic phase with the T315I mutation, take the medication exactly as instructed. Learn more

The T315I gene mutation and resistance   If testing shows that you have developed the T315I mutation, this may affect the way you are responding to your current medication. Mutations can lead to drug resistance. If your doctor determines you have the T315I mutation, be sure to ask if SCEMBLIX may be a treatment option for you.

Next: Common and Serious Side Effects of SCEMBLIX >