For Patients and Caregivers

VENCLEXTA-based regimens offer well-studied safety profiles with exposure limited to 1 year1*

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VEN+G safety
Grade 3/4 AEs
Cardiovascular adverse events
TLS

No ongoing treatment exposure1

The fixed duration of VEN+G results in limited treatment exposure.

VEN+G safety from the CLL14 trial

  • The median duration of exposure to VENCLEXTA (venetoclax tablets) was 10.5 months (range: 0-13.5 months). The median number of cycles was 6 for GAZYVA® (obinutuzumab)
  • In the VEN+G arm, 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, compared to 1% (3/214) of patients in the GCIb arm1,4
  • Serious adverse reactions were reported in 49% of patients in the VEN+G arm, most often due to febrile neutropenia and pneumonia (5% each)
  • Tumor lysis syndrome (TLS) is an important identified risk when initiating VENCLEXTA
  • There were no new safety signals detected at the 6-year follow-up27
  • TLS prophylaxis and monitoring protocols can reduce the risk of TLS
  • The 5-week ramp-up dosing schedule is designed to gradually reduce tumor burden (debulk) and decrease the risk of TLS

Rates of discontinuation, dose reduction, and dose interruption1

  • In the VEN+G arm, adverse reactions led to treatment discontinuation in 16% of patients, dose reduction in 21%, and dose interruption in 74%
  • Neutropenia led to discontinuation of VENCLEXTA in 2% of patients, reduction in 13%, and dose interruption in 41%

Adverse reactions (≥10%) in patients treated with VEN+G1

Adverse reaction by body system VEN+G (N=212) GClb (N=214)
Any Grade
(%)		 Grade ≥3
(%)		 Any Grade
(%)		 Grade ≥3
(%)
Blood and lymphatic system disorders
Neutropenia* 60 56 62 52
Anemia* 17 8 20 7
Gastrointestinal disorders
Diarrhea 28 4 15 1
Nausea 19 0 22 1
Constipation 13 0 9 0
Vomiting 10 1 8 1
General disorders and administration site conditions
Fatigue* 21 2 23 1
Infections and infestations
Upper respiratory tract infection* 17 1 17 1

*Includes multiple adverse reaction terms.

For laboratory abnormalities data, please see Table 10 in the VENCLEXTA full Prescribing Information.

Granulocyte colony-stimulating factor (G-CSF) was used to treat neutropenia in 44% of patients in the VEN+G arm and 46% of patients in the GClb arm.2

Cardiovascular adverse events in patients treated with VEN+G25†‡

Adverse Event by Body System VEN+G (N=212) GClb (N=214)
Any Grade
(%)		 Grade ≥3‡
(%)		 Any Grade
(%)		 Grade ≥3‡
(%)
Cardiac disorders
Atrial fibrillation 3 2 2 1
Myocardial infarction§ 2 2 1 1
Cardiac failure 2 2 <1 0
Vascular disorders
Hypertension 7 3 5 <1
Hypotension 5 1 4 2

The analysis was not powered to demonstrate a statistically significant difference between VEN+G and GClb adverse events.

†Based on data as of clinical data cutoff date of August 23, 2019.
‡Shown are Grade 3, 4, and 5 events with frequency 1% or higher and their corresponding Any Grade rates.
§Includes multiple adverse reaction terms.

No additional VEN+G drug exposure after stopping treatment at 1 year1

Limit patients’ VEN+G exposure and potential side effects after completing treatment27

There were no new safety signals detected at the 6-year follow-up.27

  • Other important Grade 3/4 AEs
    • Febrile neutropenia: 4% during combination therapy period, 0% during single-agent period, 1% during off treatment period
    • Pneumonia: 3% during combination therapy period, 1% during single-agent period, 3% during off treatment period
    • TLS: 1% during combination therapy period, 0% during single-agent period, 0% during off treatment period
  • VEN+G combination-therapy period (6 cycles): includes Grade 3 and 4 treatment-emergent AEs occurring on or before last exposure data of GAZYVA + 29 days
  • VENCLEXTA single-agent period (6 cycles): includes treatment-emergent AEs occurring after start of VENCLEXTA monotherapy period to last exposure date of VENCLEXTA + 29 days
  • Off treatment: includes Grade 3/4 AEs occurring after 29 days and up to 6 months after treatment completion
  • Multiple occurrences of the same AE in an individual during the same treatment period are counted only once for that treatment period

‖Based on data as of clinical cutoff date of November 14, 2022.27
The chart reflects Grade 3/4 AEs with incidence ≥5%.27

Tumor lysis syndrome is an important identified risk when initiating VENCLEXTA1

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AEs=adverse events; CLL=chronic lymphocytic leukemia; GClb=GAZYVA + chlorambucil; SLL=small lymphocytic lymphoma; VEN+G=VENCLEXTA + GAZYVA.

NEXT: VEN+R Safety Profile

US-VENC-230082

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 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 combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% 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.

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 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.
  • In patients with CLL/SLL receiving monotherapy, the most frequent serious adverse reactions (≥5%) were pneumonia (9%), febrile neutropenia (5%), and sepsis (5%). The most common adverse reactions (≥20%) of any grade were neutropenia (50%), diarrhea (43%), nausea (42%), upper respiratory tract infection (36%), anemia (33%), fatigue (32%), thrombocytopenia (29%), musculoskeletal pain (29%), edema (22%), and cough (22%). Fatal adverse reactions that occurred in the absence of disease progression and within 30 days of venetoclax treatment were reported in 2% of patients in the VENCLEXTA monotherapy studies, most often (2 patients) from septic shock.

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 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.

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VENCLEXTA® and its design are registered trademarks of AbbVie Inc.
GAZYVA® is a registered trademark of Genentech, Inc.

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