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® (asciminib) tablets 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)
    • This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Ph+ CML in CP with the T315I mutation

Dosage and Administration

Oral Dosing

Patients previously treated with 2 or more TKIs may take SCEMBLIX 80 mg once daily or 40 mg twice daily. Patients harboring the T315I mutation may take 200 mg twice daily

Patients previously treated with 2 or more TKIs may take SCEMBLIX 80 mg once daily or 40 mg twice daily. Patients harboring the T315I mutation may take 200 mg twice daily


Icon showing not to take SCEMBLIX with food Patients should avoid food consumption for at least 2 hours before and 1 hour after taking SCEMBLIX® (asciminib) tablets1

Icon alerting patients to not break the pill SCEMBLIX tablets should be swallowed whole—patients should not break, crush, or chew them1

Icon showing 2 sizes of SCEMBLIX pills SCEMBLIX is available as film-coated tablets: 20 mg (6.2 mm diameter) and 40 mg (8.2 mm diameter)1

Based on pharmacokinetic parameters studied in an exposure-response safety analysis, the predicted efficacy and safety profile of SCEMBLIX at the 80 mg qd dose is similar to the 40 mg bid dose.2

Dosage Modifications1

For the management of adverse reactions, reduce the SCEMBLIX dose as described in the table below.

Table of dosing modifications for SCEMBLIX

Table of dosing modifications for SCEMBLIX

Dosage Modifications for the Management of Adverse Reactions1

Adverse reaction 

Dosage modification

Thrombocytopenia and/or neutropenia

ANC less than 1.0 x 109/L and/or PLT less than 50 x 109/L

Withhold SCEMBLIX until resolved to ANC greater than or equal to 1 x 109/L and/or PLT greater than or equal to 50 x 109/L.

If resolved:

• Within 2 weeks: Resume SCEMBLIX at starting dose

• After more than 2 weeks: Resume SCEMBLIX at reduced dose

For recurrent severe thrombocytopenia and/or neutropenia, withhold SCEMBLIX until resolved to ANC greater than or equal to 1 x 109/L and PLT greater than or equal to 50 x 109/L, then resume at reduced dose.

Asymptomatic amylase and/or lipase elevation

Elevation greater than 2.0 x ULN

Withhold SCEMBLIX until resolved to less than 1.5 x ULN.

• If resolved, resume SCEMBLIX at reduced dose. If events reoccur at reduced dose, permanently discontinue SCEMBLIX

• If not resolved, permanently discontinue SCEMBLIX. Perform diagnostic tests to exclude pancreatitis

Nonhematologic adverse reactions

Grade 3a or higher

Withhold SCEMBLIX until recovery to Grade 1 or less.

• If resolved, resume SCEMBLIX at reduced dose

• If not resolved, permanently discontinue SCEMBLIX

ANC, absolute neutrophil count; PLT, platelets; ULN, upper limit of normal.

aBased on Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

 

References: 1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 2. Data on file. Exposure-Response Report and Amendment. Novartis Pharmaceuticals Corp; 2021.

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*The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V2.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed November 19, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

INDICATIONS

SCEMBLIX® (asciminib) tablets 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)
    • This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Ph+ CML in CP with the T315I mutation

 

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
  • 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, 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, and amylase increased

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.