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.
VIALE-C evaluated VENCLYXTO plus low-dose cytarabine (VEN+LDAC), an alternative to combination with hypomethylating agents (VEN+HMAs). The primary endpoint (statistically significant improvement in overall survival) was not met, therefore, secondary endpoints are descriptive only. VIALE-C was a randomised (2:1), double-blind, placebo-controlled, Phase 3 study that evaluated the efficacy and safety of VEN+LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy.1,2
DOSING MANAGEMENT FOR VENCLYXTO + LOW-DOSE CYTARABINE
*Grade 4 neutropaenia (ANC <500/μL) with or without fever or infection; or Grade 4 thrombocytopaenia (platelet count <25,000/μL).1,3
RECOMMENDATIONS FOR THE MANAGEMENT OF CONCOMITANT DRUG INTERACTIONS
If a CYP3A inhibitor must be used, follow the recommended dosing modifications1,3
DOSE MODIFICATIONS FOR USE WITH CYP3A, P-GP INHIBITORS, AND INDUCERS
*VENCLYXTO is an inhibitor and substrate of P-gp and BCRP and a weak inhibitor of OATP1B1.
Considerations for use with CYP3A inhibitors
| • | 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; BCL-2=B-cell lymphoma 2; BCRP=breast cancer resistance protein; CYP3A=cytochrome P450 3A; G-CSF=granulocyte colony-stimulating factor; HMA=hypomethylating agent; IV=intravenous; LDH=lactate dehydrogenase; LDAC=low-dose cytarabine; P-gp=permeability glycoprotein; SC=subcutaneous; TLS=tumour lysis syndrome; VEN=VENCLYXTO; WBC=white blood cell.
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References: 1. VENCLEXTA Prescribing Information. North Chicago, IL: AbbVie Inc. 2. Wei AH, Montesinos P, Ivanov V, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. Blood. 2020;135(24):2137-2145. doi:10.1182/blood.2020004856 3. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. December 2022.
ALL-VNCAML-220066 October 2023