Prescribing information

 

SCEMBLIX is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.1

 

The below content is for healthcare professionals in Great Britain only. If you require information for Northern Ireland please refer to the Northern Ireland prescribing information.

 

__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

SCEMBLIX®▼ (asciminib) resulted in fewer all-grade and grade ≥3 AEs vs bosutinib2,3

The ASCEMBL trial population was not restricted to Ph+ patients with CML-CP.2 SCEMBLIX is indicated in adults with Ph+ CML-CP previously treated with two or more TKIs and without a known T315I mutation.1

Patients receiving SCEMBLIX and bosutinib, respectively, experienced:

WEEK 24:2

Table showing % of patients with ≥1 adverse event at week 24

 

WEEK 96:3

Table showing % of patients with ≥1 adverse event at week 96

 

Most frequent all-grade AEs by Week 96 (occurring in ≤20% of patients in any treatment arm)3

Analysis ongoing at the time of data cut-off: 6 October 2021.

Bar graph showing most frequent AEs by week 96

aThrombocytopenia includes: thrombocytopenia and platelet count decreased.
bNeutropenia includes: neutropenia and neutrophil count decreased.

Adapted from Hochhaus, et al. 2023.3

Please refer to the Summary of Product Characteristics for further information on risk management, key contraindications, warnings and side effects.1

By Week 96, all-grade AEs leading to dose adjustment or interruption, occurred in 42.3% of patients receiving SCEMBLIX vs 64.5% of patients receiving bosutinib.3

The median duration of exposure (range) by the data cutoff was 23.7 (0.0–46.2) months on SCEMBLIX and 7.0 (0.2–43.3) months on bosutinib.3

Patients on SCEMBLIX experienced fewer all-grade/grade ≥3 AEs vs bosutinib and required fewer dose modifications2,3

 

Patients taking SCEMBLIX experienced lower treatment discontinuation vs bosutinib2

Discontinuation rates due to AEs at Week 242

discontinuation-rates

Patients still on treatment at time of cut off*3

treatment-time-of-cutoff

Consistent with the primary analysis, the most common AEs leading to discontinuation were thrombocytopenia (3.2%) and neutropenia (2.6%) for SCEMBLIX and increased ALT (3.9%) and neutropenia (3.9%) for bosutinib at the cut-off date.*

Adverse events observed with SCEMBLIX in clinical studies1

System organ class Frequency categorya Adverse reaction
Infections and infestations Very common Upper respiratory tract infectionb
  Common Lower respiratory tract infection,c influenza
Blood and lymphatic system disorders Very common Thrombocytopeniad, neutropenia.e anaemiaf
  Uncommon Febrile neutropenia
Metabolism and nutrition disorders Very common Dyslipidaemiag
  Common Decreased appetite
Nervous system disorders Very common Headache, dizziness
Eye disorders Common Dry eye, vision blurred
Cardiac disorders Common Palpitations
Vascular disorders Very common Hypertensionh
Respiratory, thoracic and mediastinal disorders Very common Cough
  Common Pleural effusion, dyspnoea, non-cardiac chest pain
Gastrointestinal disorders Very common Pancreatic enzymes increased,i vomiting, diarrhoea, nausea, abdominal painj
  Common Pancreatitisk
Hepatobiliary disorders Very common Hepatic enzyme increasedl
  Common Blood bilirubin increasedm
Skin and subcutaneous tissue disorders Very common Rashn
  Common Urticaria
Musculoskeletal and connective tissue disorders Very common Musculoskeletal pain,o arthralgia
General disorders and administration site conditions Very common Fatigue,p pruritus
  Common Pyrexia,q oedemar
Investigations Common Blood creatine phosphokinase increased
  Uncommon Electrocardiogram QT prolonged
Immune system disorders Uncommon Hypersensitivity

aFrequency based on the safety pool (A2301 + X2101) SCEMBLIX all grade events (N=356).

bUpper respiratory tract infection includes: upper respiratory tract infection, nasopharyingitis, pharyngitis and rhinitis.

cLower respiratory tract infections includes: pneumonia, bronchitis and tracheobronchitis.

dThrombocytopenia includes: thrombocytopenia and platelet count decreased.

eNeutropenia includes: neutropenia and neutrophil count decreased.

fAnaemia includes: anaemia, haemoglobin decreased, normocytic anaemia.

gDyslipidaemia includes: hypertriglyceridaemia, blood cholesterol increased, hypercholesterolaemia, blood triglycerides increased, hyperlipidaemia and dyslipidaemia.

hHypertension includes: hypertension and blood pressure increased.

iPancreatic enzymes increased includes: lipase increased, amylase increased and hyperlipasaemia.

jAbdominal pain includes: abdominal pain and abdominal pain upper.

kPancreatitis includes: pancreatitis and pancreatitis acute.

lHepatic enzymes increased includes: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased and transaminases increased.

mBlood bilirubin increased includes: blood bilirubin increased, bilirubin conjugated increased and hyperbilirubinaemia.

nRash includes: rash and rash maculopapular.

oMusculoskeletal pain includes: pain in extremity, back pain, myalgia, bone pain, musculoskeletal pain, neck pain, musculoskeletal chest pain, musculoskeletal discomfort.

pFatigue includes: fatigue and asthenia.

qPyrexia includes: pyrexia and body temperature increased.

rOedema includes: oedema and oedema peripheral.

For the management of adverse reactions, the dose can be reduced based on individual safety and tolerability. Please see the Summary of Product Characteristics for further information on dose modifications for adverse events.1

Contrandication: Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics.1

Myelosuppression1
Thrombocytopenia, neutropenia and anaemia occurred in patients receiving SCEMBLIX. Severe (NCI-CTCAE grade 3 or 4) thrombocytopenia and neutropenia events were reported during treatment with SCEMBLIX. Myelosuppression was generally reversible and managed by temporarily withholding treatment. Complete blood counts should be performed every two weeks for the first 3 months of treatment and then monthly thereafter, or as clinically indicated. Patients should be monitored for signs and symptoms of myelosuppression.

Based on the severity of thrombocytopenia and/or neutropenia, the dose should be reduced, temporarily withheld or permanently discontinued.

Pancreatic toxicity1
Pancreatitis and asymptomatic elevation of serum lipase and amylase, including severe reactions, occurred in patients receiving SCEMBLIX.

Serum lipase and amylase levels should be assessed monthly during treatment with SCEMBLIX, or as clinically indicated. Patients should be monitored for signs and symptoms of pancreatic toxicity. More frequent monitoring should be performed in patients with a history of pancreatitis. If serum lipase and amylase elevation are accompanied by abdominal symptoms, treatment should be temporarily withheld and appropriate diagnostic tests should be considered to exclude pancreatitis.

Based on the severity of serum lipase and amylase elevation, the dose should be temporarily withheld, reduced or permanently discontinued.

QT prolongation1
QT prolongation occurred in patients receiving SCEMBLIX.

It is recommended that an electrocardiogram is performed prior to the start of treatment with SCEMBLIX, and monitored during treatment as clinically indicated. Hypokalaemia and hypomagnesaemia should be corrected prior to SCEMBLIX administration and monitored during treatment as clinically indicated.

Caution should be exercised when administering SCEMBLIX concomitantly with medicinal products with a known risk of torsades de pointes, or in patients who have a history of or predisposition for QTc prolongation or uncontrolled or significant cardiac disease including bradycardia.

Hypertension1
Hypertension, including severe hypertension, occurred in patients receiving SCEMBLIX.

Hypertension should be monitored and managed using standard antihypertensive therapy during treatment with SCEMBLIX as clinically indicated.

Hepatitis B reactivation1
Reactivation of hepatitis B virus (HBV) has occurred in patients who are chronic carriers of this virus following administration of other BCR::ABL1 tyrosine kinase inhibitors (TKIs). Patients should be tested for HBV infection before the start of treatment with SCEMBLIX.

HBV carriers who require treatment with SCEMBLIX should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.

Lactose1
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Sodium1
This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium free.”

Patients taking SCEMBLIX experienced lower treatment discontinuation vs bosutinib2

Help your patients stay on treatment with SCEMBLIX2,3

LEARN ABOUT INITIATION AND DOSING

*The cut-off date for this analysis was 6 October 2021. The median duration of follow-up was 2.3 years from randomisation to data cut-off date.

AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; CML-CP, chronic myeloid leukaemia in chronic phase; NCI-CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events; Ph+, Philadelphia chromosome positive; QD, once daily; QTc, corrected QT interval; TKI, tyrosine kinase inhibitor; URTI, upper respiratory tract infection.

SCEMBLIX is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph + CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors, and without a known T315I mutation.1

For further information please refer to the Summary of Product Characteristics.

 

References

  1. SCEMBLIX (asciminib) Summary of Product Characteristics [Accessed July 2023].

  2. Réa D, et al. Blood 2021;138(21):2031–2041.

  3. Honchaus A, et al. Leukemia 2023;37:617–626.

Rate this content: 
No votes yet
UK | July 2023 | 280421

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]