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      • This website is for UK Healthcare Professionals only

      This promotional website is for UK healthcare professionals involved in the care of patients with cancer. Adverse event reporting information can be found below.

      Venclyxto_UK_R_4C
      VENCLYXTO AML PRESCRIBING INFORMATION
      VENCLYXTO GB SUMMARY OF PRODUCT CHARACTERISTICS
      VENCLYXTO NI SUMMARY OF PRODUCT CHARACTERISTICS

      UK-VNCAML-240003  |  April 2024.

      Home

      Efficacy & Safety

      Dosing & TLS prophylaxis
      (tumour lysis syndrome)

      Drug-Drug Interactions

      Cytopenia Management

      FAQs

      References

      Do any adverse events require dose-modifications?

      DOSING MODIFICATIONS BASED ON ADVERSE EVENTS?

      Management of some adverse reactions may require dose interruptions or permanent discontinuation of VENCLYXTO1,2

      Dose modifications and interruptions for cytopenias are dependent on remission status1

      Grade 4 neutropenia with or without fever or infection; or Grade 4 thrombocytopenia1*

      OCCURRENCEDOSE MODIFICATIONS
      Occurrence prior to achieving remission†In most instances, do not interrupt VENCLYXTO in combination with AZA due to cytopenias prior to achieving remission
      First occurrence after achieving remission and lasting at least 7 days

      Delay subsequent cycle of VENCLYXTO and AZA and monitor blood counts.
      Administer G-CSF if clinically indicated for neutropenia.
      Upon resolution to Grade 1 or 2:

      • Resume VENCLYXTO at the same dose in combination with AZA
      Subsequent occurrences in cycles after achieving remission and lasting 7 days or longer 

      Delay subsequent cycle of VENCLYXTO and AZA and monitor blood counts.
      Administer G-CSF if clinically indicated for neutropenia.
      Upon resolution to Grade 1 or 2:

      • Resume VENCLYXTO at the same dose in combination with AZA, and
      • Reduce VENCLYXTO duration by 7 days during each of the subsequent cycles, such as 21 days instead of 28 days.

      Refer to AZA Prescribing Information for additional information.

      Grade 3 or 4 non-haematological toxicities1

      OCCURRENCEDOSE MODIFICATIONS
      Any occurrence

      Interrupt VENCLYXTO if not resolved with supportive care
      Upon resolution to Grade 1 or baseline level:

      • Resume VENCLYXTO at the same dose
      Grading Definitions

      Please refer to SmPC for full prescribing information.

      Footnotes

      *Grade 4 neutropenia (ANC <500/μL) with or without fever or infection; or Grade 4 thrombocytopenia (platelet count <25,000/μL).1

      †Consider bone marrow evaluation to assess remission.1

      ANC=absolute neutrophil count; AZA=azacitidine; G-CSF=granulocyte-colony stimulating factor.

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      UK-VNCAML-240067  |  April 2024. 

      VENCLYXTO in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.1

      You are advised to read the Prescribing Information and Summary of Product Characteristics (GB SmPC; NI SmPC) to evaluate patient suitability for VENCLYXTO.

      Adverse events should be reported.
      Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. 
      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

      Grading Definitions

      Neutropenia3

      Grade 1: ANC 1000 to 1500/μL 

      Grade 2: ANC 500 to 999/μL 

      Grade 3: ANC 200 to 499/μL 

      Grade 4: ANC <500/μL 

       

      Thrombocytopenia4

      Grade 1: Platelet count 75,000-150,000/μL

      Grade 2: Platelet count 50,000-74,999/μL

      Grade 3: Platelet count 25,000-49,999/μL

      Grade 4: Platelet count <25,000/μL 

      Non-haematological toxicity5

      Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated

      Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living

      Grade 3: severe or medically significant but not immediately life threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self care activities of daily living

      Grade 4: life threatening consequences; urgent intervention indicated

       

      References

      1. VENCYLXTO Summary of Product Characteristics.
      2. DiNardo CD et al. N Engl J Med. 2020; 383(7): 617-29. 
      3. Newburger PE, Dale DC. Semin Hematol. 2013 Jul;50(3):198-206.
      4. Tamamyan G et al. Crit Rev Oncol Hematol. 2016 Mar;99:299-307.
      5. Eviq.org.au. Non-haematological toxicity. Available at: https://www.eviq.org.au/dose-mod-gradings/standard-ctcae/non-haematological-toxicity
      6.  

      Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie on GBPV@abbvie.com

       

      This website is for UK Healthcare Professionals only

      UK-ABBV-230225. Date of preparation June 2023. This website has been developed and funded by AbbVie Ltd.

      © 2023 AbbVie Ltd. All rights reserved. Registered Number: 08004972 England.