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 duri