For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7) (HR=0.66 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC was 7.2 months (95% CI: 5.6-10.1) vs 4.1 months for LDAC alone (95% CI: 3.1-8.8) (HR=0.75 [95% CI: 0.52-1.07; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
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BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
For newly diagnosed patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy1
VENCLYXTO is the first approved BCL-2 inhibitor for the treatment of AML1
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
VENCLYXTO plus azacitidine demonstrated a 5.1-month increase in median overall survival vs AZA alone1*
VENCLYXTO plus low-dose cytarabine showed a 3.1-month increase in median overall survival vs LDAC alone1†
*VIALE-A was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus AZA in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus AZA was 14.7 months (95% CI: 11.9-18.7) vs 9.6 months for AZA alone (95% CI: 7.4-12.7) (HR=0.66 [95% CI: 0.52-0.85; P<0.001]).1
†VIALE-C was a randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of VENCLYXTO plus LDAC in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The median overall survival with VENCLYXTO plus LDAC was 7.2 months (95% CI: 5.6-10.1) vs 4.1 months for LDAC alone (95% CI: 3.1-8.8) (HR=0.75 [95% CI: 0.52-1.07; P=0.114]).1
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.
▼
BCL-2=B-cell lymphoma 2; AZA=azacitidine; LDAC=low-dose cytarabine; CI=confidence interval; HR=hazard ratio.
test
Dosing recommendations for patients with AML
Rapid dose ramp-up safely attains the recommended daily dose1
VENCLYXTO is administered orally once daily with the dose increasing per the titration schedule, which depends on the combination agent
- Start VENCLYXTO and the combination agent on the same first day of the treatment cycle
- VENCLYXTO should be taken whole with a meal and water at approximately the same time each day
- VENCLYXTO is available in 10-mg, 50-mg, and 100-mg film-coated tablets
- Approved dosing in AML differs from approved dosing in CLL
CLL=chronic lymphocytic leukemia.
Recommendations for starting VENCLYXTO in special populations1
PATIENTS WITH HEPATIC IMPAIRMENT: DOSING CONSIDERATIONS
PATIENTS WITH HEPATIC IMPAIRMENT: DOSING CONSIDERATIONS
- For severe hepatic impairment, reduce the dose of VENCLYXTO by at least 50% throughout treatment
- These patients should be monitored more closely for signs of toxicity
PATIENTS WITH RENAL IMPAIRMENT: DOSING CONSIDERATIONS
PATIENTS WITH RENAL IMPAIRMENT: DOSING CONSIDERATIONS
CLcr=creatinine clearance; TLS=tumor lysis syndrome.
[Placeholder for safety balance required by local regulations]
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Reference: 1. VENCLYXTO Summary of Product Characteristics. Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. <Current SmPC.>