GAZYVA Is the First and Only Approved
Therapy That Demonstrated Superior PFS *
vs rituximab in Previously Untreated FL 1
FIRST
AND ONLY
With chemotherapy † for stage II bulky, III, and IV patients
GAZYVA and rituximab were each combined with bendamustine, CHOP, or CVP, and followed by
GAZYVA or rituximab monotherapy, respectively, in patients who responded.
*
HR=0.72, 95% CI, 0.56-0.93; P=0.0118; PFS events, 108 (18%) in the GAZYVA arm vs 141 (23.5%)
in the rituximab arm; 38-month median observation time.
†
Important Safety Information (cont’d)
Infusion Reactions (cont’d) Infections
• For patients with any Grade 4 infusion reactions,
including but not limited to anaphylaxis, acute life-
threatening respiratory symptoms, or other life-
threatening infusion reaction: Stop the GAZYVA infusion.
Permanently discontinue GAZYVA therapy
• For patients with Grade 1, 2, or 3 infusion reactions:
Interrupt GAZYVA for Grade 3 reactions until resolution
of symptoms. Interrupt or reduce the rate of the infusion
for Grade 1 or 2 reactions and manage symptoms
• 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 fi rst hour
after administration until blood pressure is stable. For
patients at increased risk of hypertensive crisis, consider
the benefi ts versus the risks of withholding their
antihypertensive medication
Hypersensitivity Reactions Including Serum Sickness
• Hypersensitivity reactions have been reported in
patients treated with GAZYVA. Signs of immediate-
onset hypersensitivity included dyspnea, bronchospasm,
hypotension, urticaria and tachycardia. Late-onset
hypersensitivity diagnosed as serum sickness has also
been reported with symptoms that include chest pain,
diff use arthralgia and fever. Hypersensitivity reactions
may be diffi cult to clinically distinguish from infusion
related reactions. However, hypersensitivity very rarely
occurs with the fi rst infusion and, when observed, often
occur after previous exposure. If a hypersensitivity
reaction is suspected during or after an infusion, the
infusion must be stopped and treatment permanently
discontinued. Patients with known hypersensitivity
reactions to GAZYVA, including serum sickness, must
not be retreated
Tumor Lysis Syndrome (TLS)
• Tumor lysis syndrome, including fatal cases, has been
reported in patients receiving GAZYVA. Patients with
high tumor burden, high circulating lymphocyte count
(>25 x 10 9 /L) or renal impairment are at greater risk
for TLS and should receive appropriate tumor lysis
prophylaxis with antihyperuricemics (eg, allopurinol
or rasburicase) and hydration prior to the infusion of
GAZYVA. During the initial days of GAZYVA treatment,
monitor the laboratory parameters of patients
considered at risk for TLS. For treatment of TLS, correct
electrolyte abnormalities, monitor renal function and
fl uid balance, and administer supportive care, including
dialysis as indicated • Fatal and serious bacterial, fungal, and new or
reactivated viral infections can occur during and
following GAZYVA therapy. When GAZYVA is
administered with chemotherapy followed by GAZYVA
monotherapy, Grade 3 to 5 infections have been
reported in up to 8% of patients during combination
therapy, up to 13% of patients during monotherapy, and
up to 8% of patients after treatment. 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
• In GALLIUM, more Grade 3 to 5 infections were reported
in the recipients of GAZYVA and bendamustine (117/410
patients, 29%), as compared to GAZYVA plus CHOP
or CVP (43/281 patients, 15%). More fatal infections
were reported in patients treated with GAZYVA and
bendamustine (3%), as compared to GAZYVA plus CHOP
or CVP (<1%), including during the monotherapy phase
and after completion of treatment
Neutropenia
• Severe and life-threatening neutropenia, including
febrile neutropenia, has been reported during treatment
with GAZYVA. Monitor patients with Grade 3 to 4
neutropenia 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
(GCSF) 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. Consider antiviral and
antifungal prophylaxis
Thrombocytopenia
• Severe and life threatening thrombocytopenia has been
reported during treatment with GAZYVA in combination
with chemotherapy. Fatal hemorrhagic events have
been reported in patients with NHL treated with
GAZYVA in combination with chemotherapy, including
during Cycle 1. Monitor all patients frequently for
thrombocytopenia and hemorrhagic events, especially
during the fi rst cycle. In patients with Grade 3 or 4
thrombocytopenia, monitor platelet counts more
frequently until resolution and consider subsequent
dose delays of GAZYVA and chemotherapy or dose
reductions of chemotherapy. Transfusion of blood
products (i.e., platelet transfusion) may be necessary.
Consider withholding concomitant medications which
may increase bleeding risk (platelet inhibitors or
anticoagulants), especially during the fi rst cycle