SCEMBLIX is an ABL/BCR-ABL1 tyrosine kinase inhibitor, and inhibits the ABL1 kinase activity of the BCR::ABL1 fusion protein, by binding to the ABL myristoyl pocket.

Yes, SCEMBLIX is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

SCEMBLIX is also indicated for adult patients with previously treated Ph+ CML-CP and Ph+ CML-CP with the T315I mutation.

SCEMBLIX has a once daily, oral dosing option to accommodate your patients.

The recommended dose of SCEMBLIX in patients with newly diagnosed or previously treated Ph+ CML-CP is 80 mg taken orally once daily at approximately the same time each day, or 40 mg orally twice daily at approximately 12-hour intervals.

Patients should avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX. Swallow SCEMBLIX whole—do not break, crush, or chew SCEMBLIX tablets.

Warnings and precautions associated with SCEMBLIX include myelosuppression, pancreatic toxicity, hypertension, hypersensitivity, cardiovascular toxicity, and embryo-fetal toxicity.

The most common adverse reactions (≥ 20%) are musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain, arthralgia, and diarrhea.

The most common select laboratory abnormalities (≥ 20%) are lymphocyte count decreased, leukocyte count decreased, platelet count decreased, neutrophil count decreased, calcium corrected decreased, lipase increased, cholesterol increased, uric acid increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, hemoglobin decreased, triglycerides increased, creatine kinase increased, amylase increased, and aspartate aminotransferase (AST) increased.

To view additional safety data, visit the Safety in Newly Diagnosed Patients section of this website.

• MMR rate at Week 48 for SCEMBLIX vs IS-TKIs (all) and vs IS-TKIs (imatinib stratum) (two primary end points)

• MMR rate at Week 96 for SCEMBLIX vs IS-TKIs (all) and vs IS-TKIs (imatinib stratum) (key secondary end points)

To view other study end points, visit the Study Design page located in the Efficacy in Newly Diagnosed Patients section of this website. 

To sign up for Novartis Patient Support, your patients must:

• Be 18 years of age or older

• Live in the United States or Puerto Rico

• Be prescribed SCEMBLIX for an on-label indication

Novartis Patient Assistance Foundation, Inc. (NPAF) is an independent, 501(c)(3) non-profit entity that provides certain medications at no cost to eligible patients who cannot afford the cost of their Novartis medication, are uninsured or have government insurance, and meet income guidelines and other eligibility criteria. NPAF does not provide product to individuals having insurance associated with any type of alternative funding program that conditions, restricts, or adjusts coverage based on application to NPAF or any other free goods program. Other terms and conditions may apply. Please visit www.PAP.Novartis.com ↗ or call NPAF at 1-800-277-2254 for more information.

You can enroll your patients in Novartis Patient Support for SCEMBLIX in a few simple steps:

1. Complete the Start Form on the CoverMyMeds^® portal by visiting www.covermymeds.health ↗.

Quickly enroll patients and track their progress.

OR

Download the SCEMBLIX Start Form at https://www.scemblix-hcp.com. Fill out the required sections with your patient and ensure both you and your patient sign and date the form to capture consent.

Fax completed form to Novartis Patient Support™ at fax 800-368-5564.

2. Connect with us.

Our Novartis Patient Support team is available to work alongside you and your patients every step of the way. Call us by phone: 866-433-8000, Monday-Friday, 8:00 AM-8:00 PM ET, excluding holidays.