SCEMBLIX for the T315I Gene Mutation
in Ph+ CML in Chronic Phase

Only your doctor can determine if you have Ph+ CML in chronic phase with the T315I gene mutation

SCEMBLIX® (asciminib) tablets is a prescription medicine used to treat adults with:

  • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation
It is not known if SCEMBLIX is safe and effective in children.

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

Learn more about gene mutations.

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 (19 of 45 patients) with the T315I mutation achieved a major molecular response (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.

2% of patients (19 of 45 patients) with the T315I mutation achieved a major molecular response (MMR) at 24 weeks

Ask your doctor about SCEMBLIX

If you’re not responding to your current medication for Ph+ CML in chronic phase, 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.

Common side effects of SCEMBLIX

The most common side effects of SCEMBLIX include:

  • nose, throat, or sinus (upper respiratory tract) infections
  • muscle, bone, or joint pain
  • 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

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.

Your doctor will have you take SCEMBLIX twice a day 12 hours apart. Do not eat for at least 2 hours before taking SCEMBLIX and 1 hour after your dose. Learn more about taking SCEMBLIX.