VENCLEXTA efficacy results: impressive response rates¹

Initiation

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MRD results

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Safety data

See VENCLEXTA’s well-studied safety profile for patients with 1L and R/R CLL¹

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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 with high tumor burden when treated with VENCLEXTA.
In patients with CLL 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 monotherapy studies. 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.
VENCLEXTA poses a risk for TLS at initiation and during the ramp-up phase. 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.
Patients should be assessed for TLS risk, including evaluation of tumor burden and comorbidities, and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Reduced renal function further increases the risk. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases.
Concomitant use of VENCLEXTA with P-gp inhibitors or strong or moderate CYP3A inhibitors may increase the risk of TLS at initiation and during the ramp-up phase, and requires dose adjustment due to increases in VENCLEXTA exposure.

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 treated with VENCLEXTA in combination and monotherapy studies. Febrile neutropenia occurred in 4% to 6% of patients treated with VENCLEXTA in combination and monotherapy studies.
Monitor complete blood counts throughout the treatment period. Interrupt dosing or reduce dose for severe neutropenia. Consider supportive measures including antimicrobials for signs of infection and use of 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 closely for signs and symptoms of infection and treat promptly. Withhold VENCLEXTA for Grade 3 and higher infection.

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 avoid pregnancy during treatment.

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%).
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%).
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%).

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. Adjust VENCLEXTA dosage and closely monitor patients for signs of VENCLEXTA toxicities. 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.
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.
Monitor international normalized ratio (INR) closely in patients receiving warfarin.

Lactation

Advise nursing women to discontinue breastfeeding during treatment with VENCLEXTA.

Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for at least 30 days after the last dose.
Based on findings in animals, male fertility may be compromised by treatment with VENCLEXTA.

Hepatic Impairment

Reduce the dose of VENCLEXTA for patients with severe hepatic impairment (Child-Pugh C); monitor these patients more closely for signs of toxicity. No dose adjustment is recommended for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

Please see full Prescribing Information.

Indication

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

VENCLEXTA efficacy results: impressive response rates¹

1L

VEN+G demonstrated impressive rates of complete remission with 12 months of treatment¹

IRC-assessed PFS (primary endpoint)

Response rates assessed by INV (secondary endpoint)^†

‹ Previous — See 1L PFS

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R/R

VEN+R demonstrated impressive response rates with ~24 months* of treatment¹

IRC-assessed PFS (primary endpoint)

IRC-assessed overall response rate (secondary endpoint)

‹ Previous — See R/R PFS

See R/R MRD — Next ›

Initiation

Explore Starting VENCLEXTA ›

MRD results

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Safety data

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Important Safety Information & Indication

Important Safety Information

Contraindication

Tumor Lysis Syndrome

Neutropenia

Infections

Immunization

Embryo-Fetal Toxicity

Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone

Adverse Reactions

Drug Interactions

Lactation

Females and Males of Reproductive Potential

Hepatic Impairment

Indication

VENCLEXTA efficacy results: impressive response rates 1

VEN+G demonstrated impressive rates of complete remission with 12 months of treatment 1

IRC-assessed PFS (primary endpoint)

Response rates assessed by INV (secondary endpoint)†

‹ Previous — See 1L PFS

See 1L MRD — Next ›

VEN+R demonstrated impressive response rates with ~24 months* of treatment 1

IRC-assessed PFS (primary endpoint)

IRC-assessed overall response rate (secondary endpoint)

‹ Previous — See R/R PFS

See R/R MRD — Next ›

Initiation

Explore Starting VENCLEXTA ›

MRD results

View data ›

Safety data

View data ›

Important Safety Information & Indication

Important Safety Information

Contraindication

Tumor Lysis Syndrome

Neutropenia

Infections

Immunization

Embryo-Fetal Toxicity

Increased Mortality in Patients with Multiple Myeloma when VENCLEXTA is Added to Bortezomib and Dexamethasone

Adverse Reactions

Drug Interactions

Lactation

Females and Males of Reproductive Potential

Hepatic Impairment

Indication

VENCLEXTA efficacy results: impressive response rates¹

VEN+G demonstrated impressive rates of complete remission with 12 months of treatment¹

Response rates assessed by INV (secondary endpoint)^†

VEN+R demonstrated impressive response rates with ~24 months* of treatment¹