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

Patient Profiles

Patients With Signs of Intolerance

 

SCEMBLIX patient profile Brooks

Explore the efficacy and safety profile of SCEMBLIX and see what it can mean for patients like Brooks, who have a history of suboptimal responses and are now showing signs of early intolerance.

Brooks is an accountant who lives with his partner, their 3 children, and family dog. Although he primarily works from home, he enjoys being out and about with his family and his clients.

 

Recently, he started a different Ph+ CML-CP treatment and has developed increased ALT and AST, as well as a bothersome grade 3 rash.

 

Current Clinical Presentation
  • 50 years old
  • Diagnosed 6 years ago
  • After ~5.5 years on his 1st TKI, switched treatments due to loss of response
  • After 3 months on his 2nd TKI, he is experiencing a bothersome grade 3 rash and increased ALT/AST (signaling early intolerance)
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): 7%
 
Medical History
  • Diabetes managed with insulin
  • Currently on 2nd TKI
    • On 1st TKI for ~5.5 years
      • At 1 year, patient achieved MMR (BCR::ABL1: ≤0.1%)
      • At 5 years, patient lost MMR (BCR::ABL1: 1.3%)
      • Switched treatments due to loss of response
    • On 2nd TKI for 3 months
      • Patient has grade 3 rash and increased ALT/AST
      • Patient underwent a mutational analysis. No resistant mutation was identified

 

 

 

SCEMBLIX patient profile Ramona

Review the tolerability profile and low discontinuation rate of SCEMBLIX vs bosutinib (8% vs 26% at the Week 96 analysis) and see what it can mean for patients like Ramona, who are experiencing a pulmonary reaction.1

Ramona is a retired real estate agent and grandmother of 6 who has just taken up knitting. She has been enjoying her time at home but recently developed pleural effusion with coughing and shortness of breath on her current treatment.

 

Current Clinical Presentation
  • 70 years old
  • Diagnosed 2 years ago
  • After ~5 months on her 1st TKI, switched treatments due to grade 3 edema
  • After 1 year on her 2nd TKI, she is experiencing pulmonary adverse reactions—grade 2 pleural effusion (with coughing and shortness of breath)
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): ≤0.1%
 
Medical History
  • Active dyslipidemia managed with a statin
  • Currently on 2nd TKI
    • On 1st TKI for ~5 months
      • Switched treatments due to grade 3 peripheral edema after
        unsuccessful dose reduction and resolved after treatment with diuretics
    • On 2nd TKI for 1 year
      • Patient is maintaining MMR (BCR::ABL1: ≤0.1%)
      • Patient has developed grade 2 pleural effusion
      • HCP is considering a pulmonary consult to discuss thoracentesis after an unsuccessful dose reduction

 

 

 

SCEMBLIX patient profile Maria

Learn about the efficacy and tolerability of SCEMBLIX and see what it can mean for patients like Maria, who are experiencing both a lack of response and intolerance.

Maria is a nurse and proud grandmother of 2 who is constantly on the go. She had to switch from her Ph+ CML-CP treatment after 7 years because fatigue was affecting her daily life.

 

Now 1 year into her 2nd treatment, she is once again experiencing fatigue and also diarrhea, which are holding her back at work and at home, and she is not responding to treatment.

 

Current Clinical Presentation
  • 63 years old
  • Diagnosed 8 years ago
  • After ~7 years on her 1st TKI, switched treatments due to an adverse reaction
  • After 1 year on her 2nd TKI, she is experiencing fatigue and diarrhea (signaling possible intolerance)
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): 1.5% (signaling a lack of response)
 
Medical History
  • History of controlled anxiety
  • Currently on 2nd TKI
    • On 1st TKI for ~7 years
      • Achieved MMR (BCR::ABL1: ≤0.1%)
      • Switched treatments due to grade 2 fatigue
      • Dose reduction was not effective in reducing fatigue and there was concern about reduced efficacy
    • On 2nd TKI for 1 year
      • Patient has not yet achieved CCyR (BCR::ABL1: 1.5%)
      • Patient is still experiencing grade 2 fatigue and has now developed grade 2 diarrhea
      • Dose reduction has not been effective in reducing fatigue and diarrhea

 

 

Patients With Suboptimal Responses

 

SCEMBLIX patient profile Jim

Learn about the superior response rates of SCEMBLIX vs bosutinib at the early time point of Week 24 (MMR 25% vs 13%) and what that can mean for patients like Jim, who are experiencing an early lack of response.1

Jim is a physical therapist who is constantly on the go helping his patients and coaching his son’s soccer team. Although his Ph+ CML-CP diagnosis is relatively new, he had to switch treatments after 2 years because of a loss of response.

 

As early as 3 months into starting his 2nd treatment, he has signs of a lack of response.

 

Current Clinical Presentation
  • 42 years old
  • Diagnosed 3 years ago
  • After 2 years on his 1st TKI, switched treatments due to loss of response
  • After 6 months on his 2nd TKI, his BCR::ABL1 transcript levels are still greater than 10% (signaling a lack of response)
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): 10.1%
 
Medical History
  • No other conditions
  • Currently on 2nd TKI
    • On 1st TKI for >2 years
      • Patient did not achieve EMR (BCR::ABL1: 11% at 3 months), but HCP kept patient on treatment
      • At 6 months, patient reached BCR::ABL1: 5%
      • At 1 year, patient reached MMR (BCR::ABL1: ≤0.1%)
      • At 2 years, patient lost MMR (BCR::ABL1: 1%), which was not initially detected due to lack of follow-up with HCP
      • Switched treatment due to loss of response
    • On 2nd TKI for 6 months
      • At 3 months, patient did not reach EMR (BCR::ABL1: 10.5%)
      • At 6 months, his BCR::ABL1 levels are 10.1%
      • Patient underwent a mutational analysis; no resistant mutation was identified

 

 

 

SCEMBLIX patient profile Apollo

See how patients with suboptimal responses, like Apollo, may benefit from the superior response rates of SCEMBLIX as demonstrated vs bosutinib in a Phase 3 trial (MMR rate at Week 96: 38% vs 16%).1,2

Apollo is a high school English teacher who lives with his wife and 2 sons. After 4 years on the same Ph+ CML-CP treatment, he had to switch treatments due to a loss of response.

 

Now, 1 year later, he has a suboptimal response on his current TKI.

 

Current Clinical Presentation
  • 51 years old
  • Diagnosed with Ph+ CML-CP 5 years ago
  • After 4 years on his 1st TKI, switched treatments due to loss of response
  • After 1 year on his 2nd TKI, he has not achieved CCyR (signaling a suboptimal response)
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): 5%
 
Medical History
  • Occasional GERD treated with a PPI
  • Currently on 2nd TKI
    • On 1st TKI for ~4 years
      • At 2 years, patient achieved MMR (BCR::ABL1: ≤0.1%)
      • At 4 years, patient lost MMR (BCR::ABL1: 0.6%)
      • Intolerance led to adherence issues and missed doses
      • Dose reduction was not effective in alleviating these issues and led to a loss of response
    • On 2nd TKI for 1 year
      • Patient has not achieved CCyR (BCR::ABL1: 5%)
      • Patient underwent a mutational analysis; no resistant mutation was identified

 

 

Patients With the T315I Mutation

 

SCEMBLIX patient profile Lily

Learn about the effectiveness and safety of SCEMBLIX in patients like Lily, who have the T315I mutation.

Lily is a restaurant manager who lives with her husband. A year after being diagnosed with Ph+ CML-CP, she found out that she has the T315I mutation, which can be more challenging to treat.

 

Current Clinical Presentation
  • 40 years old
  • Diagnosed 1 year ago
  • After experiencing resistance on her 1st TKI, she had a mutational analysis
  • Ponatinib naive
  • Recently tested positive for T315I mutation
  • Quantitative RT-PCR (qPCR) using IS for BCR::ABL1 (blood): 9%
 
Medical History
  • No other past medical history or comorbidities
  • Family history of acute myocardial infarction
  • Has been on her 1st TKI for 1 year
    • Patient achieved BCR::ABL1 transcript levels of 6% at 6 months
    • At 12 months, she has not achieved CCyR and her BCR::ABL1 transcript levels have increased to 9%
  • Patient recently underwent a mutational analysis and tested positive for the T315I mutation

 

 

ALT, alanine aminotransferase; AST, aspartate aminotransferase; CCyR, complete cytogenetic response; EMR, early molecular response; GERD, gastroesophageal reflux disease; IS, International Scale; MMR, major molecular response; MMR, major molecular response; Ph+ CML-CP, Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase; PPI, proton-pump inhibitor; TKI, tyrosine kinase inhibitor.

References:  1. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 2. Data on file. CABL001A2301 clinical study report. Novartis Pharmaceuticals Corp; 2022.

 

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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.