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

Patient Profiles

Patients With Signs of Intolerance

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.

Review the tolerability data >

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

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

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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

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.

Review the tolerability data >

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

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

Review the efficacy data >

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

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

Review the efficacy data >

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

T315I Mutation

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

Learn more about 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.