IMPORTANT SAFETY INFORMATION (CONT’D)
Tumor Lysis Syndrome (TLS)
Pregnancy: Category C
Acute
renal
failure,
hyperkalemia,
hypocalcemia,
hyperuricemia,
•
• There are no adequate and well-controlled studies of GAZYVA
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
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
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
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.
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
Please see the following pages for the brief summary of
events during Cycle 1 have also been reported. Monitor all
full Prescribing Information, including Boxed WARNINGS.
patients frequently for thrombocytopenia and hemorrhagic
events, especially during the first cycle. In patients with Grade 3 References: 1. GAZYVA full Prescribing Information. South San Francisco, CA:
or 4 thrombocytopenia, monitor platelet counts more frequently Genentech USA, Inc.; December 2014. 2. Data on file. Genentech, Inc. 3. Howlade "