Oncology:
Our other therapy areas

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      • This website is for UK Healthcare Professionals only

      Prescribing information can be accessed by the Prescribing Information button on the left

      UK-VNCAML-220170  |  November 2022. 

      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

      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 [email protected]

      CO-ADMINISTERED DRUG   VENCLYXTO INITIATION AND
      DOSE-TITRATION PHASE      		 VENCLYXTO STEADY DAILY DOSE
      (POST DOSE-TITRATION PHASE)
      CYP3A INDUCERS
      Strong CYP3A inducer > Avoid Avoid
      Moderate CYP3A inducer > Avoid Avoid

       

      CO-ADMINISTERED DRUG   VENCLYXTO INITIATION AND
      DOSE-TITRATION PHASE      		 VENCLYXTO STEADY DAILY DOSE
      (POST DOSE-TITRATION PHASE)
      CYP3A INHIBITORS
      Strong CYP3A inhibitor† >

      Cautionary‡
      Reduce the VENCLYXTO dose to:
      Day 1: 10 mg
      Day 2: 20 mg
      Day 3: 50 mg      		 Day 4 onwards:
      ≤100 mg or by at least 75% if already
      modified for other reasons
      Moderate CYP3A inhibitor† >

      Cautionary‡
      Reduce the VENCLYXTO dose by at least 50%

       

      CO-ADMINISTERED DRUG   VENCLYXTO INITIATION AND
      DOSE-TITRATION PHASE      		 VENCLYXTO STEADY DAILY DOSE
      (POST DOSE-TITRATION PHASE)
      OTHERS INHIBITORS
      P-gp and BCRP inhibitors >

      Cautionary‡
      Concomitant use should be avoided at initiation and during the dose-titration phase; if a P-gp or BCRP inhibitor must be used, patients should be monitored closely for signs of toxicities
      Bile acid sequestrants >

      Cautionary‡
      Co-administration of bile acid sequestrants is not recommended. If a bile acid sequestrant is to be co-administered consult the SmPC of the sequestrant to reduce the risk of interactions. Administer VENCLYXTO 4–6 hours after the sequestrant

       

      COMMON EXAMPLES OF CYP3A INDUCERS/INHIBITORS*
      AVOID USING VENCLYXTO WITH: USE VENCLYXTO WITH CAUTION WITH:

      Strong CYP3A inducers

      • Carbamazepine
      • Phenytoin
      • Rifampicin

      Strong CYP3A inhibitors

      • Itraconazole
      • Ketoconazole
      • Posaconazole
      • Voriconazole
      • Clarithromycin
      • Ritonavir

       

      Moderate CYP3A inducers

      • Bosentan
      • Efavirenz
      • Etravirine
      • Modafinil
      • Nafcillin

      Moderate CYP3A inhibitors

      • Ciprofloxacin
      • Diltiazem
      • Erythromycin
      • Fluconazole
      • Verapamil

      DOES USE OF ANTIMICROBIAL PROPHYLAXIS IMPACT PATIENT OUTCOMES WITH VENCLYXTO?

      Antimicrobial prophylaxis with CYP3A inhibitors was used in neutropenic patients in the VIALE-A study, with overall similar composite remission rates with VENCLYXTO dose reductions2*

      OVERALL SURVIVAL

      Median OS in patients receiving VEN+AZA was not statistically different regardless of use of moderate or strong CYP3A inhibitor2

      ADVERSE EVENTS

      Rates of discontinuation from infections were similar across all patients treated with VEN+AZA regardless of CYP3Ai use2

      RESPONSES

      Rates of CR+CRi as best response in the VEN+AZA arm of VIALE-A were similar with concomitant use of CYP3A inhibitor vs. no use2

      Graphs adapted from Jonas BA et al.

      VIALE-A was a phase 3, randomised (2:1), placebo-controlled, trial evaluating the efficacy and safety of VEN+AZA vs. PBO+AZA in first-line adult AML patients ineligible for intensive chemotherapy. VEN+AZA acheived its primary endpoints, achieving statistically significant increases in overall survival and CR/CRi rates vs AZA alone (p<0.001 for both).

      *Neutropenic patients were defined as having an ANC <500/µL.2

      ANC=absolute neutrophil count; CI=confidence interval; CR=complete remission; CRi=CR with incomplete count recovery; CYP3Ai=cytochrome P450 3A inhibitor;
      OS=overall survival; VEN=VENCLYXTO. 

      References

      1. VENCYLXTO Summary of Product Characteristics for UK.
      2. Jonas BA et al. Poster 2846. ASH 62nd; Dec 5-8, 2020; Virtual.
      3. DiNardo CD, et al. N Engl J Med. 2020;383(7):617-29.

      OVERALL SURVIVAL

      Median OS in patients receiving VEN+AZA was not statistically different regardless of use of moderate or strong CYP3A inhibitor2*

      Adapted from Jonas BA et al.

      *As noted by overlapping confidence intervals.

      ADVERSE EVENTS

      Rates of discontinuation from infections were similar across all patients treated with Ven+AZA regardless of CYP3A inhibitor use2*

      Graph adapted from Jonas BA et al.

      *Reported AEs that began within the the first 2 cycles of treatment with CYP3Ai were reported as being given for prophylaxis.

      RESPONSES

      Rates of CR+CRi as best response in the VEN+AZA arm of VIALE-A were similar with concomitant use of CYP3A inhibitor vs. no use2*

      Graph adapted from Jonas BA et al.

      *CR=ANC ≥1,000/μl, platelets ≥100,000/μl, red blood cell transfusion independence, bone marrow with <5% blasts; absence of circulating blasts and blasts with Auer rods, and absence of extramedullary disease. 

      CRi=ANC <1,000/μl or platelets <100,000/μl1,3