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SCEMBLIX for Ph+ CML-CP With the T315I Gene Mutation.

If you have Ph+ CML-CP with the T315I gene mutation, SCEMBLIX may be able to help

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

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

If you have Ph+ CML-CP with the T315I gene mutation, ask your doctor if SCEMBLIX may be right for you.

The effect of SCEMBLIX was studied in Ph+ CML-CP adults with the T315I mutation in a clinical study

  • 42% of patients (19 out of 45 patients) with the T315I mutation achieved a major molecular response (MMR) by 24 weeks

  • 49% of patients (22 out of 45 patients) achieved MMR by 96 weeks

More than 4 out of 10 patients achieved MMR by 24 weeks.

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

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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. Here’s a guide to help you get the conversation started. 

 

Download Doctor Discussion Guide

 

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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

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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.