This promotional website is for UK Healthcare Professionals involved in the management of haematological malignancies. Adverse event reporting information can be found below.
Safety Profile1-4
VEN+O and VEN+R
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were:
Neutropenia, diarrhoea, and upper respiratory tract infection.1
The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were:
Pneumonia, sepsis, febrile neutropenia, and TLS.1
VEN+I
In GLOW and CAPTIVATE (FD-Cohort) clinical studies, the most commonly occurring adverse events (≥20%) of any grade in patients receiving VEN+I were:
GLOW: Diarrhoea, neutropenia* and nausea2
CAPTIVATE (FD-Cohort): Diarrhoea, nausea, neutropenia and arthralgia3
*Includes ‘neutropenia’ and ‘neutrophil count decreased’
In GLOW and CAPTIVATE (FD-Cohort) clinical studies, The most frequently reported serious adverse reactions (≥2%) in patients receiving VEN+I were:
GLOW: Infections†, atrial fibrillation, anaemia, diarrhoea and cardiac failure2
CAPTIVATE (FD-Cohort): Cellulitis and pneumonia3
†Includes multiple preferred terms. These include: pneumonia, bronchitis, bronchopulmonary aspergillosis, cellulitis, clostridium colitis, erysipelas, gastroenteritis, gastrointestinal infection, infection, influenza, cytomegaloviral pneumonia, septic shock, tonsillitis; patient may have had more than one adverse event.
VEN+A
Of the 291 patients treated with VEN+A, the most common (≥20%) ADRs of any grade reported in patients were:
Infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain4
The most commonly reported (≥5%) Grade ≥3 ADR was:
neutropenia4
Please refer to the VENCLYXTO SmPC and the SmPC of the respective combination agent (available at www.medicines.org.uk) for full safety information
ADR, Adverse drug reaction; FD, Fixed duration; SmPC, Summary of Product Characteristics; TLS, Tumour lysis syndrome; VEN+A, VENCLYXTO + acalabrutinib; VEN+I, VENCLYXTO + ibrutinib; VEN+O, VENCLYXTO + obinutuzumab; VEN+R, VENCLYXTO + rituximab.
References
- VENCLYXTO Summary of Product Characteristics.
- Kater AP et al. NEJM Evid. 2022;1(7) doi: 10.1056/EVIDoa2200006 (and suppl.).
- Tam CS et al. Blood. 2022; 139(22): 3278-89 (and suppl.).
- Acalabrutinib Summary of Product Characteristics.
UK-VNCCLL-260054. Date of Preparation: July 2026.
You are advised to read the Prescribing Information and Summary of Product Characteristics to evaluate patient suitability for VENCLYXTO.
VENCLYXTO PRESCRIBING INFORMATION
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