ASH Clinical News Focus on Myeloid Malignancies | Page 16

For CLL patients with
17p deletion who
have received at least
one prior therapy...
AIM
Indication and Important Safety Information
Indication
• VENCLEXTA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL) with 17p deletion, as detected by an
FDA-approved test, who have received at least one prior therapy. a
• This indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial.
Important Safety Information
Contraindication
• Concomitant use of VENCLEXTA with strong CYP3A inhibitors at
initiation and during ramp-up phase is contraindicated.
Tumor Lysis Syndrome
• Tumor lysis syndrome (TLS), including fatal events and renal failure
requiring dialysis, has occurred in previously treated CLL patients with
high tumor burden treated with VENCLEXTA.
• VENCLEXTA poses a risk for TLS in the initial 5-week 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 (CrCl <80 mL/min)
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 and P-gp inhibitors may increase the risk of
TLS at initiation and during the ramp-up phase, and may require
dose adjustment due to increases in VENCLEXTA exposure.
Neutropenia
• Grade 3 or 4 neutropenia occurred in 41% (98/240) of patients
treated with VENCLEXTA. Monitor complete blood counts
throughout treatment. 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).
Immunization
• Do not administer live attenuated vaccines prior to, during, or
after treatment with VENCLEXTA until B-cell recovery. Advise
patients that vaccinations may be less effective.
Embryo-Fetal Toxicity
• VENCLEXTA may cause embryo-fetal harm when administered
VENCLEXTA™ is a trademark of AbbVie, Inc.
Distributed and marketed by AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL 60064
Marketed by Genentech USA, Inc., 1 DNA Way, South San Francisco, CA 94080-4990
©2016 AbbVie, Inc. and Genentech USA, Inc.
750-1839967/July 2016
Printed in USA