IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION for SCEMBLIX® (asciminib) tablets

Myelosuppression

Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
Perform complete blood counts every 2 weeks for the first 3 months of treatment and monthly thereafter or as clinically indicated. Monitor patients for signs and symptoms of myelosuppression

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INDICATIONS

SCEMBLIX is indicated for the treatment of adult patients 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

Unmet Needs in CML

Challenges for Resistant and Intolerant Patients

Patients with suboptimal responses and/or intolerance to 2 or more TKIs may need a different approach^1-6

More than half of patients with CML on their 3rd TKI were intolerant to prior TKIs⁷

Addressing intolerance after multiple TKIs remains an urgent need.^7,8

Cycling through ATP-competitive TKIs may lead to low response rates^3,9,10

In a Phase 1/2 study of 118 patients receiving bosutinib who had been previously treated with ≥2 TKIs¹¹:

Finding the right treatment for these patients is key to meeting critical milestones.^1-6

Patient Scenarios in Later Lines

CONSIDER A DIFFERENT Ph+ CML-CP TREATMENT FOR:

Patients who are intolerant to ATP-competitive TKI therapy in the ≥2nd-line setting¹²

These patients can face challenges that can lead to dosing changes or
interruptions, as well as treatment discontinuation.¹¹

See Patients With Signs of Intolerance >

Patients with suboptimal responses to ATP-competitive TKI therapy in the ≥2nd-line setting¹²

These patients may have never responded, started losing the responses they initially achieved, or their responses have plateaued.^2,9,10

See Patients With Suboptimal Responses >

Patients who have the T315I mutation¹²

These patients have limited treatment options.¹

See Patient With the T315I Mutation >

Patient portrayals.

Until 2021, no treatments had demonstrated superior efficacy, such as response rates, vs a 2nd-generation TKI in a Phase 3 trial.^1,12-19

_{ATP, adenosine 5’-triphosphate.}

_{*Data based on a multicenter, open-label Phase 1/2 study of best cumulative response rates to bosutinib (starting dose: 500 mg/day) in patients previously treated with and who developed resistance to a 1st-line TKI. Additionally, these patients were resistant to or intolerant to a ≥2nd-line TKI. One patient in the study had CML-AP. The median follow-up was 28.5 months. In this study, CCyR was defined as 0% Ph+ metaphases, and MMR was defined as ≥3-log reduction from standardized baseline in ratio of BCR::ABL to ABL transcripts.}

^{References: 1. Soverini S, Gnani A, Colarossi S, et al. Blood. 2009;114(10):2168-2171. 2. Garg RJ, Kantarjian H, O’Brien S, et al. Blood. 2009;114(20):4361-4368. 3. Ibrahim AR, Paliompeis C, Bua M, et al. Blood. 2010;116(25):5497-5500. 4. Gambacorti-Passerini C, Brümmendorf TH, Kim D-W, et al. Am J Hematol. 2014;89(7):732-742. 5. Shah NP, Kim D-W, Kantarjian H, et al. Haematologica. 2010;95(2):232-240. 6. Kantarjian HM, Giles FJ, Bhalla KN, et al. Blood. 2011;117(4):1141-1145. 7. Giles FJ, Abruzzese E, Rosti G, et al. Leukemia. 2010;24(7):1299-1301. 8. Hochhaus A, Gambacorti-Passerini C, Abboud C, et al. Leukemia. 2020;34(8):2125-2137. 9. Bosi GR, Fogliatto LM, Costa TEV, et al. Hematol Transfus Cell Ther. 2019;41(3):222-228. 10. Iacob RE, Zhang J, Gray NS, Engen JR. PLoS One. 2011;6(1):e15929. 11. Khoury JH, Cortes JE, Kantarjian HM, et al. Blood. 2012;119(15):3403-3411. 12. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 13. O’Brien SG, Guilhot F, Larson RA, et al. N Engl J Med. 2003;348(11):994-1004. 14. Saglio G, Kim D-W, Issaragrisil S, et al. N Engl J Med. 2010;362(24):2251-2259. 15. Kantarjian H, Shah NP, Hochhaus A, et al. N Engl J Med. 2010;362(24):2260-2270. 16. Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. J Clin Oncol. 2018;36(3):231-237. 17. Kantarjian HM, Giles FJ, Bhalla KN, et al. Blood. 2011;117(4):1141-1145. 18. Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Blood. 2011;118(17):4567-4576. 19. Shah NP, Kantarjian HM, Kim D-W, et al. J Clin Oncol. 2008;26(19):3204-3212.}

Watch experts talk about SCEMBLIX >

Reference: 1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.

INDICATIONS

SCEMBLIX is indicated for the treatment of adult patients 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

IMPORTANT SAFETY INFORMATION for SCEMBLIX

Myelosuppression

Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
Perform complete blood counts every 2 weeks for the first 3 months of treatment and monthly thereafter or as clinically indicated. Monitor patients for signs and symptoms of myelosuppression
Based on the severity of thrombocytopenia and/or neutropenia, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information

Pancreatic Toxicity

Pancreatitis (including grade 3 reactions) and asymptomatic elevation in serum lipase and amylase (including grade 3/4 elevations), have occurred in patients receiving SCEMBLIX
Assess serum lipase and amylase levels monthly during treatment with SCEMBLIX, or as clinically indicated. Monitor patients for signs and symptoms of pancreatic toxicity. Perform more frequent monitoring in patients with a history of pancreatitis
If lipase and amylase elevation are accompanied by abdominal symptoms, temporarily withhold SCEMBLIX and consider appropriate diagnostic tests to exclude pancreatitis
Based on the severity of lipase and amylase elevation, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information

Hypertension

Hypertension, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
Monitor and manage hypertension using standard antihypertensive therapy during treatment with SCEMBLIX as clinically indicated
For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypertension

Hypersensitivity

Hypersensitivity, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX. Reactions included rash, edema, and bronchospasm
Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated
For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypersensitivity

Cardiovascular Toxicity

Cardiovascular toxicity (including ischemic cardiac and central nervous system conditions; and arterial thrombotic and embolic conditions) and cardiac failure have occurred in patients receiving SCEMBLIX. Some toxicities were grade 3/4 and 3 fatalities were reported
Arrhythmia, including QTc prolongation, have occurred in patients receiving SCEMBLIX. Some of these arrhythmias were grade 3
Monitor patients with a history of cardiovascular risk factors for cardiovascular signs and symptoms. Initiate appropriate treatment as clinically indicated
For grade 3 or higher cardiovascular toxicity, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of cardiovascular toxicity

Embryo-Fetal Toxicity

SCEMBLIX can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus if SCEMBLIX is used during pregnancy or if the patient becomes pregnant while taking SCEMBLIX
Verify the pregnancy status of females of reproductive potential prior to starting treatment with SCEMBLIX. Advise females to use effective contraception during treatment and for at least 1 week after the last SCEMBLIX dose

ADVERSE REACTIONS

Most common adverse reactions (≥20%) were upper respiratory tract infections, musculoskeletal pain, headache, fatigue, nausea, rash, and diarrhea
Most common laboratory abnormalities (≥20%) were platelet count decreased, triglycerides increased, neutrophil count decreased, hemoglobin decreased, creatine kinase increased, alanine aminotransferase increased, lipase increased, amylase increased, aspartate aminotransferase increased, uric acid increased, and lymphocyte count decreased

DRUG INTERACTIONS

Asciminib is an inhibitor of CYP3A4, CYP2C9, and P-gp. Asciminib is a CYP3A4 substrate
Closely monitor for adverse reactions during concomitant use of strong CYP3A4 inhibitors and SCEMBLIX at 200 mg twice daily
Avoid concomitant use of itraconazole oral solution containing hydroxypropyl-β-cyclodextrin and SCEMBLIX at all recommended doses
Closely monitor for adverse reactions during concomitant use of certain CYP3A4 substrates and SCEMBLIX at 80 mg total daily dose. Avoid use of SCEMBLIX at 200 mg twice daily
Avoid concomitant use of CYP2C9 substrates and SCEMBLIX at all recommended doses. If coadministration with 80 mg total daily dose is unavoidable, reduce the CYP2C9 substrate dosage as recommended in its prescribing information. If coadministration with 200 mg twice daily is unavoidable, consider alternative therapy with a non-CYP2C9 substrate
Closely monitor for adverse reactions during concomitant use of certain P-gp substrates and SCEMBLIX at all recommended doses

Please see full Prescribing Information.