Haematology
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      • VENCLEXTA logo

      VEN+AZA SAFETY PROFILE (VIALE-A TRIAL)

      In VIALE-A, the phase 3 randomised, double-blind, placebo-controlled, trial that compared VENCLEXTA + azacitidine (N=286) vs azacitidine + placebo (N=145) in adult patients with newly diagnosed AML who were ineligible for intensive chemotherapy:1

      Most common grade  ≥3 adverse reactions (incidence ≥20% and ≥2% higher for VEN+AZA vs AZA + placebo) at a median follow-up of 20.5 months1

      au-aml-safety-profile

      aIncludes thrombocytopenia and platelet count decreased. bIncludes neutropenia and neutrophil count decreased. cIncludes anaemia and haemoglobin decreased. 

      Serious adverse reactions

      • 83% of patients in the VEN+AZA group had a serious adverse reaction vs 73% receiving AZA + placebo1
      • The most frequently reported serious adverse reactions reported in ≥5% of patients receiving VEN+AZA were febrile neutropenia (30%), pneumonia (23%), and sepsis (16%)1

       

      Rate of discontinuations, dose reductions, and dose interruptions due to adverse reactions1 

      Rate of discontinuations, dose reductions and interruptions due to adverse events

      The most frequent adverse reactions (≥5%) leading to VEN dose interruptions in the VEN+AZA arm were febrile neutropenia (20%), neutropenia (20%), pneumonia (14%), thrombocytopenia (10%), and sepsis (8%).1

      Neutropenia and Infections

      Neutropenia is an identified risk with VENCLEXTA treatment. In patients with AML, grade 3 or 4 neutropenia is common before starting treatment. Neutrophil counts can worsen with VENCLEXTA in combination with azacitidine. Neutropenia can recur with subsequent cycles of therapy.1

      Complete blood counts should be monitored throughout the treatment period. Dose interruptions or dose reductions are recommended for severe neutropenia. Supportive measures should be considered, including antimicrobials for any signs of infection, and use of growth factors (e.g., granulocyte-colony stimulating factor [G-CSF]).1

      Serious infections, including events of sepsis and events with fatal outcome, have been reported in patients treated with VENCLEXTA. Monitor patients for fever and any symptoms of infection and treat promptly. Interrupt dosing as appropriate.1

       

      Neutropenia-related reactions reported with incidence ≥10% and ≥5% higher in patients treated with VEN+AZA vs AZA + placebo1

      Neutropenia and infections in CLL14

      aIncludes neutropenia and neutrophil count decreased.

      Tumour Lysis Syndrome (TLS)

      TLS, including life-threatening or fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA. VENCLEXTA can cause rapid tumour reduction and thus poses a risk for TLS at initiation and during the ramp-up phase.1

      In the VIALE-A trial, 3 patients (1.1%) experienced TLS; one of these cases was clinical TLS. All cases occurred during the dose ramp-up phase.1

      Assess all patients for risk of TLS and provide prophylactic hydration and anti-hyperuricaemics to patients prior to first dose of VENCLEXTA to reduce risk of TLS. Blood chemistries should be monitored and abnormalities managed promptly. Employ more intensive measures (intravenous hydration, frequent monitoring, and hospitalisation) as overall risk increases.1

      Please refer to the VENCLEXTA Product Information for full safety information including prophylaxis and/or monitoring recommendations for neutropenia, serious infection and TLS.

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      VENCLEXTA PBS information: VENCLEXTA (venetoclax) in combination with rituximab is PBS listed for relapsed or refractory chronic lymphocytic leukaemia (CLL). VENCLEXTA in combination with obinutuzumab is PBS listed for first line treatment of CLL or small lymphocytic lymphoma (SLL). VENCLEXTA in combination with azacitidine is PBS listed for treatment of acute myeloid leukaemia (AML). General Schedule listing. Authority required (telephone). Refer to PBS schedule for full authority information. VENCLEXTA monotherapy is not listed on the PBS. VENCLEXTA in combination with low-dose cytarabine is not listed on the PBS for treatment of AML.

      PLEASE REVIEW FULL PRODUCT INFORMATION (PI) BEFORE PRESCRIBING VENCLEXTA. FULL PI IS AVAILABLE FROM ABBVIE PTY LTD BY CALLING 1800 043 460 OR ACCESSED HERE.

      AML: acute myeloid leukaemia. AZA: azacitidine. CI: confidence interval. HR: hazard ratio. ITT: intention-to-treat. TLS: tumour lysis syndrome. VEN: VENCLEXTA. 
      References: 1.  VENCLEXTA Product Information. 

       

      AU-VENA-210067. Last revised September 2022