ASH Clinical News ACN_6.4s_SUPP_full_issue | Page 2

VENCLEXTA: NEW 48-MONTH DATA IN R/R CLL
THE ONLY CHEMO-FREE REGIMENS
DESIGNED TO STOP
AFTER AFTER
12 MONTHS ~24 MONTHS
OF TREATMENT IN 1L CLL
WITH VENCLEXTA
+GAZYVA® (obinutuzumab) 1 *
OF TREATMENT IN R/R CLL
WITH VENCLEXTA
+rituximab 1†
* The VEN+G regimen is designed to be completed after 12 months (twelve 28-day treatment cycles): GAZYVA is administered in Cycles 1-6 and VENCLEXTA is taken orally 400 mg/day from
Cycle 3, Day 1, after the first cycle of GAZYVA and the 5-week VENCLEXTA dose ramp-up.
†
The VEN+R regimen is designed to be completed after ~24 months (twenty-four 28-day treatment cycles after the 5-week VENCLEXTA dose ramp-up): rituximab is administered at
375 mg/m 2 on Day 1, Cycle 1 and 500 mg/m 2 on Day 1, Cycles 2-6; VENCLEXTA is taken 400 mg/day orally from Cycle 1, Day 1 of rituximab through Cycle 24.
R/R=relapsed/refractory; CLL=chronic lymphocytic leukemia; 1L=first-line; VEN+G=VENCLEXTA + GAZYVA; VEN+R=VENCLEXTA + rituximab.
LEARN MORE AT VENCLEXTAHCP.COM
Indication and Important Safety Information
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 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 fi rst 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 strong or moderate CYP3A inhibitors or
P-gp 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.
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