VEN+O safety profile (CLL14 trial)
Common (≥10%) adverse reactions1
aIncludes multiple adverse reaction terms.
Adapted from VENCLEXTA Product Information.1
Median duration of exposure to VEN was 10.5 months (range: 1 to 13.5 months). Median number of cycles was 6 for O and 12 for Clb.1
Other adverse reactions reported in the VEN+O arm:1
- Blood & lymphatic system disorders: febrile neutropenia (6%), lymphopaenia (1%)
- Infection and infestation disorder: (all include multiple adverse reaction terms): pneumonia (9%), urinary tract infection (6%), sepsisb (4%)
- Metabolism and nutrition disorder: hyperuricaemia (4%), hyperkalaemia (2%), hyperphosphataemia (2%), hypocalcaemia (1%), tumour lysis syndrome (1%)
- Investigations: blood creatinine increased (3%)
b Includes the following terms: sepsis, septic shock, urosepsis.
Rate of discontinuations, dose reductions and interruptions due to adverse events1
Adapted from VENCLEXTA Product Information.1
In the CLL14 study, the most common adverse event leading to dose interruption was neutropenia. 2% of patients discontinued VENCLEXTA due to neutropenia (all grades).1
Neutropenia and Infections
Neutropenia is an identified risk associated with VENCLEXTA treatment.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 and infections in CLL141
cSome serious infections occurred some time after completion of VENCLEXTA treatment. Adapted from VENCLEXTA Product Information.1
Tumour Lysis Syndrome (TLS)
TLS, including life-threatening or fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA. It is an important identified risk when initiating VENCLEXTA.1
The risk of TLS is a continuum based on multiple factors including comorbidities, particularly reduced renal function (creatinine clearance [CrCl] <80mL/min) and tumour burden. Splenomegaly may contribute to the overall TLS risk.1
All patients should be assessed for risk and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricaemics. Blood chemistries should be monitored and abnormalities managed promptly. Employ more intensive measures (intravenous hydration, frequent monitoring, and hospitalisation) as overall risk increases.1
TLS occurred in 1% (3/212) of patients in the VEN+O arm:1,2
- All cases occurred during treatment with obinutuzumab and before treatment with VENCLEXTA
- All TLS events resolved and did not lead to withdrawal from the study
- Obinutuzumab administration was delayed in two cases in response to the TLS events
- No clinical TLS was observed
Please refer to the VENCLEXTA Product Information for full safety information including TLS prophylaxis and monitoring recommendations during initiation and dose ramp-up phase.
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PBS Information
Venclexta: 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 the full Product Information (PI) before prescribing, available below.
Clb: chlorambucil. O: obinutuzumab. TLS: tumour lysis syndrome. VEN: VENCLEXTA.
References: 1. VENCLEXTA Product Information. 2. Fischer K et al. N Engl J Med 2019; 380(23): 2225–36.
AU-ABBV-210422 Last revised October 2022