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      UK-VNCAML-240003  |  April 2024.

      UK-VNCAML-240190  |  November 2024. 

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

       

      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 rate vs AZA alone (p<0.001 for both).3

      *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.
      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=absolute neutrophil count (ANC) >1,000/microlitre, platelets >100,000/microlitre, RBC transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.

      CRi=ANC ≤1,000/microlitre or platelets ≤100,000/microlitre1