RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
For the treatment of patients with follicular lymphoma who relapsed after,
or are refractory to, a rituximab-containing regimen
CHOOSE GAZYVA PLUS BENDAMUSTINE
FOLLOWED BY GAZYVA MONOTHERAPY1
IMPORTANT SAFETY INFORMATION (CONT’D)
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
• Severe and life-threatening neutropenia, including febrile neutropenia,
has been reported during treatment with GAZYVA. 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. Consider administration of
granulocyte colony-stimulating factors (G-CSF) in patients with Grade
3 or 4 neutropenia
• Neutropenia can also be of late onset (occurring more than 28 days
after completion of treatment) and/or prolonged (lasting longer than
28 days)
• Consider dose delays in the case of Grade 3 or 4 neutropenia. Patients
with severe and long lasting (>1 week) neutropenia are strongly
recommended to receive antimicrobial prophylaxis until resolution
of neutropenia to Grade 1 or 2. Antiviral and antifungal prophylaxis
should be considered
Thrombocytopenia
• Severe and life threatening thrombocytopenia has been reported
during treatment with GAZYVA in combination with bendamustine.
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 bendamustine or dose reductions of bendamustine.
Transfusion of blood products (ie, platelet transfusion) may be
necessary. Consider withholding concomitant medications which
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 have not been studied.
Immunization with live virus vaccines is not recommended during
treatment and until B-cell recovery