ASH Clinical News March 2015 | Page 34

IMPORTANT SAFETY INFORMATION (CONT’D)
Infusion Reactions (cont’d)
• For patients with preexisting cardiac or pulmonary conditions,

monitor more frequently throughout the infusion and the
post-infusion period since they may be at greater risk of
experiencing more severe reactions. Hypotension may occur
as part of the GAZYVA infusion reaction. Consider withholding
antihypertensive treatments for 12 hours prior to and during
each GAZYVA infusion, and for the first hour after administration
until blood pressure is stable. For patients at increased risk
of hypertensive crisis, consider the benefits versus the risks of
withholding their antihypertensive medication

Tumor Lysis Syndrome (TLS)
• Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia,
and/or hyperphosphatemia from TLS can occur within 12-24
hours after the first infusion. Patients with high tumor burden
and/or high circulating lymphocyte count (>25 x 109/L) are
at greater risk for TLS and should receive appropriate tumor
lysis prophylaxis with antihyperuricemics (eg, allopurinol)
and hydration beginning 12-24 hours prior to the infusion
of GAZYVA. For treatment of TLS, correct electrolyte
abnormalities, monitor renal function and fluid balance, and
administer supportive care, including dialysis, as indicated

Infections
• Serious bacterial, fungal, and new or reactivated viral

infections can occur during and following GAZYVA therapy.
Fatal infections have been reported with GAZYVA. Do not
administer GAZYVA to patients with an active infection.
Patients with a history of recurring or chronic infections may
be at increased risk of infection

Neutropenia
• GAZYVA, in combination with chlorambucil, caused Grade 3

or 4 neutropenia in 33% of patients. Patients with Grade 3 to
4 neutropenia should be monitored frequently with regular
laboratory tests until resolution. Anticipate, evaluate, and treat
any symptoms or signs of developing infection
• Neutropenia can also be of late onset (occurring more than 28
days after completion of treatment) and/or prolonged (lasting
longer than 28 days)
• Patients with neutropenia are strongly recommended to receive
antimicrobial prophylaxis throughout the treatment period.
Antiviral and antifungal prophylaxis should be considered

Thrombocytopenia
• GAZYVA, in combination with chlorambucil, caused Grade 3

or 4 thrombocytopenia in 10% of patients in the trial. In 4%
of patients, GAZYVA caused acute thrombocytopenia occurring
within 24 hours after the GAZYVA infusion. Fatal hemorrhagic
events during Cycle 1 have also been reported. Monitor all
patients frequently for thrombocytopenia and hemorrhagic
events, especially during the first cycle. In patients with Grade 3
or 4 thrombocytopenia, monitor platelet counts more frequently
until resolution and consider subsequent dose delays of GAZYVA

and chlorambucil or dose reductions of chlorambucil. Transfusion
of blood products (ie, platelet transfusion) may be necessary.
Consider withholding concomitant medications that may
increase bleeding risk (eg, platelet inhibitors or anticoagulants),
especially during the first cycle

Immunization
• The safety and efficacy of immunization with live or attenuated
viral vaccines during or following GAZYVA therapy has not
been studied. Immunization with live virus vaccines is not
recommended during treatment and until B-cell recovery

Pregnancy: Category C
• There are no adequate and well-controlled studies of GAZYVA

in pregnant or nursing women. Women of childbearing potential
should use effective contraception while receiving GAZYVA and
for 12 months following treatment. GAZYVA should be used
during pregnancy and/or breastfeeding only if the potential
benefit justifies the potential risk to the fetus. Mothers who
have been exposed to GAZYVA during pregnancy should
discuss the safety and timing of live virus vaccinations for their
infants with their child’s healthcare providers

Geriatric Use
• Of 336 previously untreated CLL patients who received GAZYVA
in combination with chlorambucil, 273 patients (81%) were ≥65
years of age and 156 patients (46%) were ≥75 years of age.
Of the 156 patients ≥75 years of age, 72 (46%) experienced
serious adverse events and 11 (7%) experienced adverse events
leading to death. For 180 patients <75 years of age, 59 (33%)
experienced a serious adverse event and 4 (2%) experienced an
adverse event leading to death

Additional Important Safety Information
• Grade 3/4 adverse reactions were: neutropenia (33%), infusion

reactions (20%), thrombocytopenia (10%), anemia (4%),
leukopenia (4%), diarrhea (2%), urinary tract infection (1%),
pyrexia (<1%), and nasopharyngitis (<1%)
• The most common adverse reactions (incidence ≥10%) were:
infusion reactions (66%), neutropenia (38%), thrombocytopenia
(14%), nausea (12%), anemia (11%), pyrexia (10%), cough (10%),
and diarrhea (10%)

You are encouraged to report side effects to Genentech
and the FDA. You may contact Genentech by calling
1-888-835-2555. You may contact the FDA by visiting
www.fda.gov/medwatch, or calling 1-800-FDA-1088.
Please see the following pages for the brief summary of
full Prescribing Information, including Boxed WARNINGS.
References: 1. GAZYVA full Prescribing Information. South San Francisco, CA:
Genentech USA, Inc.; December 2014. 2. Data on file. Genentech, Inc.

Visit GAZYVA.com for more information

© 2015 Genentech USA, Inc. All rights reserved. GAZ/012915/0017 Printed in USA. March 2015