For Patients and Caregivers

Dosing, administration, & patient management

Initiation & Dosing

Initiation and drug interactions

Pre-treatment TLS risk assessment and prophylaxis1

Assess patient-specific factors for level of risk of TLS and provide prophylactic hydration and anti-hyperuricemics to patients prior to first dose of VENCLEXTA and continue during ramp-up to reduce risk of TLS:

  • Confirm that the patient’s white blood cell count is less than 25 × 109/L. Cytoreduction prior to treatment may be required
  • Provide appropriate prophylactic measures, including adequate hydration and anti-hyperuricemic agents prior to first VENCLEXTA dose, and continue during ramp-up phase
  • Assess blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine) and correct pre-existing abnormalities prior to initiation of treatment with VENCLEXTA
  • Monitor blood chemistries for TLS at pre-dose, 6 to 8 hours after each new dose during ramp-up, and 24 hours after reaching final dose
  • For patients with risk factors for TLS (eg, circulating blasts, high burden of leukemia involvement in bone marrow, elevated pre-treatment LDH levels, or reduced renal function), consider additional measures, including increased laboratory monitoring and reducing VENCLEXTA starting dose

TLS in clinical trials1,7

  • With implementation of dosing ramp-up plus standard TLS prophylaxis and monitoring:
    • In VIALE-A, the rate of TLS was 1.1% (3/283) in patients who received VENCLEXTA in combination with azacitidine. All events were laboratory TLS
    • In VIALE-C, the rate of TLS was 5.6% (8/142) in patients who received VENCLEXTA in combination with low-dose cytarabine. There were 4 events of laboratory TLS and 4 events of clinical TLS, which included 2 deaths and cases of renal failure

VENCLEXTA dosing schedule1

  • VENCLEXTA is taken orally in combination with AZA, DEC, or LDAC
  • Initiate AML dosing with the appropriate 3- or 4-day dose ramp-up for VENCLEXTA regimens
  • Instruct patients to take VENCLEXTA tablets with a meal and water at approximately the same time each day. VENCLEXTA tablets should be swallowed whole and not chewed or broken prior to swallowing

Dosing schedule for VEN+AZA

In VIALE-A, azacitidine was administered in 28-day cycles, beginning on Day 1 of VENCLEXTA treatment, at a dosage of 75 mg/m2, intravenously or subcutaneously once daily on Days 1-7 of each cycle.

Continue VENCLEXTA in combination with azacitidine until disease progression or unacceptable toxicity.

  • If using VENCLEXTA in combination with decitabine, follow the 3-day dose ramp-up schedule, up to 400 mg of VENCLEXTA, and administer decitabine at 20 mg/m2 intravenously once daily on Days 1-5 of each 28-day cycle beginning on Cycle 1, Day 1
  • If using VENCLEXTA in combination with low-dose cytarabine, follow the 4-day dose ramp-up schedule, up to 600 mg of VENCLEXTA, and administer cytarabine at 20 mg/m2 subcutaneously once daily on Days 1-10 of each 28-day cycle beginning on Cycle 1, Day 1

Please see Section 2.3 of the Prescribing Information for VEN+DEC or VEN+LDAC dosing.

IMPORTANT TRIAL INFORMATION1

In VIALE-A: Bone marrow assessment FOLLOWING Cycle 1

  • Once bone marrow assessment confirmed a remission, VENCLEXTA or placebo was interrupted up to 14 days or until ANC ≥500/microliter and platelet count ≥50 × 103 microliter
  • For patients with resistant disease at the end of Cycle 1, a bone marrow assessment was performed after Cycle 2 or 3 and as clinically indicated

AZA=azacitidine; DEC=decitabine; IV=intravenous; LDAC=low-dose cytarabine; TLS=tumor lysis syndrome; VEN=VENCLEXTA.

Dose Modification

Dose modifications for drug interactions1,9

  • VENCLEXTA dose should be modified for concomitant use with certain medications
  • VENCLEXTA is metabolized by the CYP3A enzyme; the dose should be reduced when used with P-gp inhibitors or strong or moderate CYP3A inhibitors

*This is not an exhaustive list and is intended only to complement, not replace, clinical judgment during treatment of patients with VENCLEXTA. Please refer to the FDA website for more examples.

  • Adjust the VENCLEXTA dose and monitor more frequently for adverse reactions. Resume the VENCLEXTA dosage that was used prior to concomitant use of a strong or moderate CYP3A inhibitor or a P-gp inhibitor 2 to 3 days after discontinuation of the inhibitor
  • Avoid grapefruit products, Seville oranges, and starfruit during treatment with VENCLEXTA, as they contain inhibitors of CYP3A
  • Concomitant use of VENCLEXTA with strong CYP3A inducers decreases VENCLEXTA exposure, which may decrease VENCLEXTA efficacy. Avoid concomitant use of VENCLEXTA with strong CYP3A inducers or moderate CYP3A inducers
  • Concomitant use of VENCLEXTA increases warfarin exposure, which may increase the risk of bleeding. Monitor international normalized ratio (INR) more frequently in patients using warfarin concomitantly with VENCLEXTA
  • Concomitant use of VENCLEXTA increases exposure of P-gp substrates, which may increase toxicities of these substrates. Avoid concomitant use of VENCLEXTA with a P-gp substrate. If concomitant use is unavoidable, separate dosing of the P-gp substrate at least 6 hours before VENCLEXTA

Modifications for severe hepatic impairment1

  • Reduce the VENCLEXTA once-daily dose by 50% for patients with severe hepatic impairment (Child Pugh C); monitor these patients more closely for adverse reactions

CYP3A=cytochrome P450; P-gp=P-glycoprotein.

Assessment & AR Management

How to assess remission

Assess for response1,3,4

  • In VIALE-A, a bone marrow assessment was conducted following Cycle 1 treatment to assess for remission
  • Once bone marrow assessment confirmed a remission,† VENCLEXTA or placebo was paused up to 14 days or until ANC ≥500/microliter and platelet count ≥50 x 103/microliter
  • For patients with resistant disease after the end of Cycle 1, a bone marrow assessment was performed after Cycle 2 or 3 and as clinically indicated
  • Responses for CR and CRh were reached at different times throughout treatment; management of Grade 4 neutropenia or thrombocytopenia differs before and after remission is achieved

In VIALE-A: select secondary endpoints3,30

  • CR: 37% (n=105/286), 95% CI: (31, 43) in VEN+AZA vs 18% (n=26/145), 95% CI: (12, 25) in AZA; P<0.001
  • CR+CRh: 65% (n=185/286), 95% CI: (59, 70) in VEN+AZA vs 23% (n=33/145), 95% CI: (16, 30) in AZA; P<0.001

Bone marrow assessment is recommended for cytopenia management since dose modifications and interruptions are dependent on remission status.1,3

According to the National Comprehensive Cancer Network® (NCCN®) the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for AML Principles of Venetoclax Use with HMA or LDAC2‡: bone marrow assessment recommended for response assessment on Days 21-28 of Cycle 1

†Defined as less than 5% leukemia blasts with cytopenia.
‡See NCCN Guidelines for AML, Version 3.2026, for complete recommendations. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Advantages of assessing AML remission with bone marrow biopsy27-29

Determine cause of cytopenia and make a clinical decision27

BMB can help determine if cytopenia is related to the active disease or the drug.

  • If caused by underlying leukemia: HCP can consider continuing treatment, as persisting cytopenia will not resolve until remission is achieved
  • If remission is achieved and the patient is cytopenic: cytopenia is likely caused by therapy and HCP may want to consider pausing treatment until counts have recovered
Accurately measure blast counts28

BMB is a more accurate way to assess count recovery and is considered a “gold standard” to detect blasts. Some patients with AML do not have circulating peripheral blood blasts, which can limit the accuracy of peripheral blood counts.

Assess overall marrow function29

BMBs measure the amount of healthy cells in the bone marrow by testing cellularity. Decreased cellularity is associated with reduction in hematopoietic activity.

BMB=bone marrow biopsy; Cl=confidence interval; CR=complete response; CRh=complete remission with partial hematologic recovery; CRi=complete remission with incomplete hematologic recovery; NCCN=National Comprehensive Cancer Network.

Managing VENCLEXTA ARs

Management of Grade 4 neutropenia or thrombocytopenia differs before and after remission is achieved1

  • Monitor blood counts frequently through resolution of cytopenias. Dose adjustments and pauses for cytopenias are dependent on remission status

Recommended dose modifications for cytopenias and non-hematologic adverse reactions in AML1

Dose modification in VIALE-A

  • Once bone marrow assessment confirmed a remission,‡ VENCLEXTA or placebo was paused up to 14 days or until ANC ≥500/microliter and platelet count ≥50 x 103/microliter1
  • In the VEN+AZA arm, among patients who achieved bone marrow clearance of leukemia, 53% (114/216)# underwent dose pauses for ANC <500/microliter1,7
  • Exploratory post hoc analysis: 75% of patients in remission [CR or CRh] (139/186) had at least 1 pause in dosing lasting 7+ days4
Appropriate patient management steps may help 1L AML patients stay on VENCLEXTA until disease progression or unacceptable toxicity
Review safety data

Dosing Tool

Learn how to determine appropriate dosing or management for your patient

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§See NCCN Guidelines for AML, Version 3.2026, for complete recommendations. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
IIRecommend bone marrow evaluation.1
Dose may vary based on drug-drug interactions or severe hepatic impairment.1
#Of patients who achieved a morphologic leukemia-free state of response or better.7

ANC=absolute neutrophil count; AR=adverse reaction.

NEXT: Instructions for Patients

US-VENA-250092

Important Safety Information & Indication

Indication

VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Important Safety Information

Tumor Lysis Syndrome
  • Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients treated with VENCLEXTA.
  • VENCLEXTA can cause rapid reduction in tumor and thus poses a risk for TLS at initiation and during the ramp-up phase in all patients. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase.
  • In patients with AML who followed the current 3-day ramp-up dosing schedule and the TLS prophylaxis and monitoring measures, the rate of TLS was 1.1% in patients who received VENCLEXTA in combination with azacitidine. In patients with AML who followed a 4-day ramp-up dosing schedule and the TLS prophylaxis and monitoring measures, the rate of TLS was 5.6% and included deaths and renal failure in patients who received VENCLEXTA in combination with low-dose cytarabine.
  • The risk of TLS is a continuum based on multiple factors, particularly reduced renal function, tumor burden, and type of malignancy.
  • Assess all patients for risk and provide appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Monitor blood chemistries and manage abnormalities promptly. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Interrupt dosing if needed; when restarting VENCLEXTA follow dose modification guidance in the Prescribing Information.
  • Concomitant use of VENCLEXTA with P-gp inhibitors or strong or moderate CYP3A inhibitors increases venetoclax exposure, which may increase the risk of TLS at initiation and during the ramp-up phase, and requires VENCLEXTA dose reduction.
Neutropenia
  • In patients with AML, baseline neutrophil counts worsened in 95% to 100% of patients treated with VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine. Neutropenia can recur with subsequent cycles.
  • Monitor complete blood counts. Interrupt dosing for severe neutropenia. Resume at same dose then reduce duration based on remission status and first or subsequent occurrence of neutropenia. Consider supportive measures including antimicrobials and growth factors (e.g., G-CSF).
Infections
  • Fatal and serious infections such as pneumonia and sepsis have occurred in patients treated with VENCLEXTA. Monitor patients for signs and symptoms of infection and treat promptly. Withhold VENCLEXTA for Grade 3 and 4 infection until resolution and resume at same dose.
Immunization
  • Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery occurs. Advise patients that vaccinations may be less effective.
Embryo-Fetal Toxicity
  • VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.
Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone
  • In a randomized trial (BELLINI; NCT02755597) in patients with relapsed or refractory multiple myeloma, the addition of VENCLEXTA to bortezomib plus dexamethasone, a use for which VENCLEXTA is not indicated, resulted in increased mortality. Treatment of patients with multiple myeloma with VENCLEXTA in combination with bortezomib plus dexamethasone is not recommended outside of controlled clinical trials.
Adverse Reactions
  • In patients with AML receiving combination therapy with azacitidine, the most frequent serious adverse reactions (≥5%) were febrile neutropenia (30%), pneumonia (22%), sepsis (excluding fungal; 19%), and hemorrhage (6%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were neutrophils decreased (98%), platelets decreased (94%), lymphocytes decreased (91%), hemoglobin decreased (61%), nausea (44%), diarrhea (43%), febrile neutropenia (42%), musculoskeletal pain (36%), pneumonia (33%), fatigue (31%), and vomiting (30%). Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with azacitidine, with the most frequent (≥2%) being pneumonia (4%), sepsis (excluding fungal; 3%), and hemorrhage (2%).
  • In patients with AML receiving combination therapy with decitabine, the most frequent serious adverse reactions (≥10%) were sepsis (excluding fungal; 46%), febrile neutropenia (38%), and pneumonia (31%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were neutrophils decreased (100%), lymphocytes decreased (100%), white blood cells decreased (100%), platelets decreased (92%), hemoglobin decreased (69%), febrile neutropenia (69%), fatigue (62%), constipation (62%), musculoskeletal pain (54%), dizziness (54%), nausea (54%), abdominal pain (46%), diarrhea (46%), pneumonia (46%), sepsis (excluding fungal; 46%), cough (38%), pyrexia (31%), hypotension (31%), oropharyngeal pain (31%), edema (31%), and vomiting (31%). One (8%) fatal adverse reaction of bacteremia occurred within 30 days of starting treatment.
  • In patients with AML receiving combination therapy with low-dose cytarabine, the most frequent serious adverse reactions (≥10%) were pneumonia (17%), febrile neutropenia (16%), and sepsis (excluding fungal; 12%). The most common adverse reactions including hematological abnormalities (≥30%) of any grade were platelets decreased (97%), neutrophils decreased (95%), lymphocytes decreased (92%), hemoglobin decreased (63%), nausea (42%), and febrile neutropenia (32%). Fatal adverse reactions occurred in 23% of patients who received VENCLEXTA in combination with LDAC, with the most frequent (≥5%) being pneumonia (6%) and sepsis (excluding fungal; 7%).
Drug Interactions
  • Concomitant use with a P-gp inhibitor or a strong or moderate CYP3A inhibitor increases VENCLEXTA exposure, which may increase VENCLEXTA toxicities, including the risk of TLS. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions. Resume the VENCLEXTA dosage that was used prior to concomitant use of a P-gp inhibitor or a strong or moderate CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor.
  • Patients should avoid grapefruit products, Seville oranges, and starfruit during treatment as they contain inhibitors of CYP3A.
  • Avoid concomitant use of strong or moderate CYP3A inducers.
  • Monitor international normalized ratio (INR) more frequently in patients receiving warfarin.
  • Avoid concomitant use of VENCLEXTA with a P-gp substrate. If concomitant use is unavoidable, separate dosing of the P-gp substrate at least 6 hours before VENCLEXTA.
Lactation
  • Advise nursing women not to breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
Females and Males of Reproductive Potential
  • Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for 30 days after the last dose.
  • Based on findings in animals, VENCLEXTA may impair male fertility.
Hepatic Impairment
  • Reduce the dose of VENCLEXTA for patients with severe hepatic impairment (Child-Pugh C); monitor these patients more frequently for signs of adverse reactions. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information.

VENCLEXTA® and its design are registered trademarks of AbbVie Inc.

    • VENCLEXTA Prescribing Information.

      VENCLEXTA Prescribing Information.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed November 24, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed November 24, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

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