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.
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML)
WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2
INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
FOR NEWLY DIAGNOSED PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY1
VENCLYXTO IS THE FIRST APPROVED BCL-2 INHIBITOR FOR THE TREATMENT OF AML1
Study M14-358 was a nonrandomised Phase 1/2 clinical trial of VENCLYXTO in combination with azacitidine (n=84) or decitabine (DEC) (n=31) in newly diagnosed patients with AML who were ineligible for intensive chemotherapy. VENCLYXTO + DEC demonstrated a 74% remission rate (CR+CRi) (95% CI: 55-88).1
DOSING MANAGEMENT FOR VENCLYXTO + DECITABINE
*Grade 4 neutropaenia (ANC <500/μL) with or without fever or infection; or Grade 4 thrombocytopaenia (platelet count <25,000/μL).1
RECOMMENDATIONS FOR THE MANAGEMENT OF CONCOMITANT DRUG INTERACTIONS
If a CYP3A inhibitor must be used, follow the recommended dosing modifications1
DOSE MODIFICATIONS FOR USE WITH CYP3A, P-GP, AND BCRP INHIBITORS AND INDUCERS
Considerations for use with CYP3A inhibitors1
| • | Concomitant use with strong or moderate CYP3A inhibitors increases VENCLYXTO exposure |
| • | Monitor patients closely for signs of toxicities that may require further dose adjustments |
| • | Resume the VENCLYXTO dose used prior to initiating the CYP3A inhibitor 2-3 days after discontinuation of the inhibitor |
AML=acute myeloid leukaemia; ANC=absolute neutrophil count; BCL-2=B-cell lymphoma 2; BCRP=breast cancer resistance protein; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete haematological recovery; CYP3A=cytochrome P450 3A; DEC=decitabine; G-CSF=granulocyte colony-stimulating factor; IV=intravenous; LDH=lactate dehydrogenase; P-gp=permeability glycoprotein; SC=subcutaneous; TLS=tumour lysis syndrome; WBC=white blood cell.
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022.
ALL-VNCAML-220066 October 2023