For Patients and Caregivers

†The VEN+A regimen is designed to be completed after 12 cycles (twelve 28-day treatment cycles), preceded by a 2-cycle acalabrutinib initiation phase. Acalabrutinib is taken orally 100 mg approximately every 12 hours starting on Cycle 1, Day 1, for a total of 14 cycles or until disease progression or unacceptable toxicity. VENCLEXTA is taken orally 400 mg/day until disease progression, unacceptable toxicity, or for a total of 12 cycles after the 2-cycle acalabrutinib initiation phase, starting with the 5-week VENCLEXTA dose ramp-up schedule.

CLL=chronic lymphocytic leukemia; VEN+A=VENCLEXTA + acalabrutinib.

National Comprehensive Cancer Network® (NCCN®)

NCCN recommends venetoclax (VENCLEXTA®) + acalabrutinib as a treatment option for CLL/SLL11‡‎

‡See NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for CLL/SLL, Version 2.2026, 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.
del(17p)=17p deletion; SLL=small lymphocytic lymphoma; TP53=tumor protein p53.

VEN+A Study Design

An all-oral treatment designed to be completed in 14 months1

The AMPLIFY trial evaluated PFS with VEN+A, with treatment completed after 2 cycles of acalabrutinib followed by 12 cycles of VEN+A

  • AMPLIFY was a randomized, multicenter, open-label trial
  • In AMPLIFY, the VEN+A regimen was designed to be completed after 12 cycles (twelve 28-day treatment cycles), preceded by a 2-cycle acalabrutinib initiation phase
    • Acalabrutinib is taken orally 100 mg approximately every 12 hours starting on Cycle 1, Day 1, for a total of 14 cycles or until disease progression or unacceptable toxicity
    • VENCLEXTA oral tablets were administered daily for a total of 12 cycles, starting with the 5-week dose ramp-up schedule: 20 mg daily during Cycle 3, Days 1-7; 50 mg daily during Cycle 3, Days 8-14; 100 mg daily during Cycle 3, Days 15-21; 200 mg daily during Cycle 3, Days 22-28; 400 mg daily during Cycle 4, Days 1-7; and then 400 mg daily until disease progression, unacceptable toxicity, or until the last day of Cycle 14
    • In the CIT arm of AMPLIFY, fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine-rituximab (BR) was administered for 6 cycles
  • AMPLIFY included an additional investigational combination regimen

Select inclusion criteria

  • Previously untreated CLL
  • No TP53 mutation or 17p deletion

Primary endpoint

  • PFS (IRC-assessed PFS for VEN+A vs CIT was the basis for FDA approval of VEN+A)

VEN+A was studied across a range of patients1

Baseline demographics and disease characteristics
Characteristic All patients (N=581)
Age, years, median (range) 61 (26-86)
Male, % 62
ECOG performance status, %  
≤1 90
Disease staging, %  
Bulky disease with lymph nodes ≥5 cm 41
Rai stage III-IV disease 45
CLL subsets, %  
IGHV unmutated 58
11q deletion 17

1L=first line; CIT=chemoimmunotherapy; ECOG=Eastern Cooperative Oncology Group; FDA=US Food and Drug Administration; IGHV=immunoglobulin heavy-chain variable gene; IRC=independent review committee; PFS=progression-free survival; TLS=tumor lysis syndrome.

VEN+A Efficacy

Empower your patients with the chance for progression-free survival without continuous treatment1

PFS was significantly improved with VEN+A vs CIT

IRC-assessed PFS (primary endpoint) in 1L CLL

After a median follow-up of 42.6 months (range: 1-59 months) in the VEN+A arm:

  • There were 89 events in the VEN+A arm (77 progressions and 12 death events) compared with 95 events in the CIT arm (66 progressions and 29 death events)
No clinically relevant differences in efficacy were observed between patients ≥65 years of age and younger adults

§The VEN+A regimen is designed to be completed after 12 cycles, preceded by a 2-cycle acalabrutinib initiation phase.
CI=confidence interval; HR=hazard ratio; NR=not reached.

VEN+A Safety

Well-characterized safety profile with low rate of discontinuation1

VEN+A safety from the AMPLIFY trial

  • Median duration of exposure to VENCLEXTA was 11.1 months (range: 2-14 months) and to acalabrutinib was 12.9 months (range: 1-18 months). Among patients who received VEN+A, 96% were exposed for ≥6 months and 91% were exposed for >1 year
  • Fatal adverse events occurred in 3.4% of patients on VEN+A. The most common fatal adverse events included COVID-19 and COVID-19 pneumonia
    • Of patients who received VEN+A, 33% (97/291) were ≥65 years of age, and 4.5% (13/291) were ≥75 years of age; fatal adverse reactions occurred in 5% and 2.6% of patients aged ≥65 years and <65 years, respectively
  • Serious adverse reactions were reported in 25% of patients receiving VEN+A. The most common serious adverse reactions (≥2%) were COVID-19 including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%)
Adverse reactions (≥15% of any grade) in patients treated with VEN+A
Adverse reaction by body system VEN+A (N=291) CIT (N=259)
All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%)
Nervous system disorders
Headache 35 1.4 8 0.4
Gastrointestinal disorders
Diarrhea 33 1.7 11 0.4
Nausea 15 0 36 0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain 25 0.7 14 0.8
Infections
COVID-19 21 6 3.9 1.5
General disorders
Fatigue 18 0.3 17 1.5
Skin and subcutaneous tissue disorders
Bruising 17 0 1.5 0
Rash 16 1 16 1.5

Includes multiple adverse reaction terms.

  • Clinically relevant adverse reactions in <15% of patients receiving VEN+A included upper respiratory tract infections, lower respiratory tract infection, arthralgia, pneumonia, hemorrhage, dizziness, constipation, vomiting, second primary malignancy, and hypertension

No ongoing treatment exposure—fixed-duration treatment with VEN+A limits cumulative drug exposure

Low discontinuation and dose reduction rates due to adverse events

  • Treatment discontinuation due to adverse reactions occurred in 8% of patients in the VEN+A arm
  • Neutropenia led to discontinuation of VENCLEXTA in 0.3% of patients, dose reduction in 7%, and dose interruption in 21%
Laboratory abnormalities (≥15% of any grade), new or worsening from baseline, in patients treated with VEN+A
Laboratory abnormality VEN+A# CIT#
All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%)
Hematologic abnormalities
Neutropenia 78 38 80 53
Lymphopenia 56 12 92 73
Thrombocytopenia 43 5 59 15
Anemia 35 7 56 8
Chemistry abnormalities
Glucose increased 74 0 84 0
Calcium decreased 30 0.7 25 2.3
ALT increased 26 3.1 28 1.6
Urate increased 25 25 23 23
LDH increased 24 0 40 0
Potassium increased 22 2.4 12 3.1
AST increased 22 1.4 28 1.6
ALP increased 20 0 15 0
Glucose decreased 20 0.3 5 0
Creatine increased 19 0.3 12 0.8
Sodium increased 15 0.3 9 0.4

#Denominator used to calculate the rate varied between 256 and 290 based on the number of patients with a baseline value and at least one post-treatment value.

  • Grade 4 laboratory abnormalities in ≥15% of patients treated with VEN+A include absolute neutrophil count decreased (15%)

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; LDH=lactate dehydrogenase.

VEN+A Dosing

Choose a 1L regimen with the convenience of all-oral administration and a chance for time off treatment1

Start with 2-month acalabrutinib initiation phase, followed by 12-month VEN+A combination treatment phase

Acalabrutinib initiation phase (2 months)
  • Acalabrutinib is taken orally 100 mg approximately every 12 hours for 2 months or until disease progression or unacceptable toxicity
VEN+A treatment phase (12 months)
  • Acalabrutinib is taken orally 100 mg approximately every 12 hours and continued until completion of 12 months or until disease progression or unacceptable toxicity in combination with VENCLEXTA
  • VENCLEXTA oral tablets are taken once daily for a total of 12 months, starting with the 5-week dose ramp-up schedule: on Month 3, Day 1, the starting dose is 20 mg once daily for 7 days, ramping up weekly to 50 mg, 100 mg, 200 mg, and finally 400 mg once daily; after completing the ramp-up schedule on Month 4, Day 7, patients should continue VENCLEXTA 400 mg once daily until disease progression, unacceptable toxicity, or until the last day of Month 14

||Approximately every 12 hours.
Graphic not to scale. Each month is a 28-day cycle.

  • With VENCLEXTA, monitor blood chemistry**†† for the first dose of each dose ramp-up week (see section 2.4 of the VENCLEXTA full Prescribing Information)
Learn about risk assessment and monitoring

Considerations with prescribing VEN+A

  • With a combination regimen like VEN+A, consider conducting Insurance Benefits Investigations for both products upfront
  • Prescribing VENCLEXTA and acalabrutinib at the same time may help optimize the patient experience and prescription fulfillment process

**Evaluate blood chemistries (potassium, uric acid, phosphorus, calcium, and creatinine); review in real time.
††For patients at risk of TLS, monitor blood chemistries at 6 to 8 hours and at 24 hours at each subsequent dose ramp-up.

VENCLEXTA: a Standard of Care

VENCLEXTA enables targeted, fixed-duration treatment in CLL1‡‡

VENCLEXTA regimens give your patients the chance to experience the freedom of time off treatment§§

No continuous
therapy‡‡
No ongoing
treatment exposure
No ongoing
out-of-pocket costs§§

‡‡The VEN+A regimen is designed to be completed after 12 cycles (twelve 28-day treatment cycles), preceded by a 2-cycle acalabrutinib initiation phase. Acalabrutinib is taken orally 100 mg approximately every 12 hours starting on Cycle 1, Day 1, for a total of 14 cycles or until disease progression or unacceptable toxicity. VENCLEXTA is taken orally 400 mg/day until disease progression, unacceptable toxicity, or for a total of 12 cycles after the 2-cycle acalabrutinib initiation phase, starting with the 5-week VENCLEXTA dose ramp-up schedule.
§§Coverage and patient out-of-pocket costs for VEN+A vary by health plan. Patients may still incur out-of-pocket costs for other treatments or tests as directed by their healthcare providers.

Explore VENCLEXTA regimens
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Request an in-office conversation with a VENCLEXTA Representative

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Financial assistance options

No matter what type of health insurance your patients have, assistance may be available

Explore options
Learn more: Financial Assistance Options

Important Safety Information & Indication

Indication

  • VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Important Safety Information

Contraindication

  • Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients with CLL/SLL due to the potential for increased risk of tumor lysis syndrome (TLS).

Tumor Lysis Syndrome

  • Tumor lysis syndrome, 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, and during reinitiation after dosage interruption in patients with CLL/SLL. 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. TLS, including fatal cases, has been reported after a single 20 mg dose.
  • In patients with CLL/SLL who followed the current (5-week) dose ramp-up and the TLS prophylaxis and monitoring measures, the rate of TLS was 2% in the VENCLEXTA CLL/SLL monotherapy trials. The rate of TLS remained consistent with VENCLEXTA in combination with obinutuzumab or rituximab. With a 2- to 3-week dose ramp-up and higher starting dose in patients with CLL/SLL, the TLS rate was 13% and included deaths and renal failure.
  • The risk of TLS is a continuum based on multiple factors, particularly reduced renal function, tumor burden, and type of malignancy. Splenomegaly may also increase the risk of TLS in patients with CLL/SLL.
  • 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 CLL, Grade 3 or 4 neutropenia developed in 63% to 64% of patients and Grade 4 neutropenia developed in 31% to 33% of patients when treated with VENCLEXTA in monotherapy and in combination studies with obinutuzumab or rituximab; febrile neutropenia occurred in 4% to 6% of patients. Grade 3 or 4 neutropenia developed in 38% of patients and Grade 4 neutropenia developed in 15% of patients when treated with VENCLEXTA in combination with acalabrutinib; febrile neutropenia occurred in 2% of patients.
  • Monitor complete blood counts. Interrupt dosing for severe neutropenia and resume at same or reduced dose. 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 or reduced dose.
  • In AMPLIFY, a randomized study in patients with previously untreated CLL/SLL, serious or Grade 3 or higher infections occurred in 14% of patients who received VENCLEXTA in combination with acalabrutinib (VEN+A), most commonly due to COVID-19; fatal infections occurred in 3.1% of patients.
  • In an additional cohort of patients receiving VENCLEXTA in combination with acalabrutinib and obinutuzumab (AVO) (an unapproved regimen for previously untreated CLL/SLL in AMPLIFY), serious or Grade 3 or higher infections occurred in 25%, most commonly due to COVID-19; fatal infections occurred in 6% of patients. The safety and effectiveness of AVO have not been established by the FDA in patients with previously untreated CLL/SLL.

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 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 CLL receiving combination therapy with acalabrutinib, serious adverse reactions were most often due to COVID-19 including COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%). The most common adverse reactions (≥20%) of any grade were neutropenia (78%), headache (35%), diarrhea (33%), musculoskeletal pain (25%), and COVID-19 (21%). Fatal adverse reactions occurred in 3.4% of patients, most often from COVID-19 and COVID-19 pneumonia.
  • In patients with CLL receiving combination therapy with obinutuzumab, serious adverse reactions were most often due to febrile neutropenia and pneumonia (5% each). The most common adverse reactions (≥20%) of any grade were neutropenia (60%), diarrhea (28%), and fatigue (21%). Fatal adverse reactions that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2% (4/212) of patients, most often from infection.
  • In patients with CLL receiving combination therapy with rituximab, the most frequent serious adverse reaction (≥5%) was pneumonia (9%). The most common adverse reactions (≥20%) of any grade were neutropenia (65%), diarrhea (40%), upper respiratory tract infection (39%), fatigue (22%), and nausea (21%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of the last VENCLEXTA treatment and/or 90 days of the last rituximab were reported in 2% (4/194) of patients.

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. Concomitant use with a strong CYP3A inhibitor at initiation and during ramp-up phase in patients with CLL/SLL is contraindicated. Consider alternative medications or adjust VENCLEXTA dosage and monitor more frequently for adverse reactions in patients taking a steady daily dosage (after ramp-up phase). 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 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 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.
All registered trademarks shown are the property of their respective owners.

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