FIRST
AND ONLY
GAZYVA Is the First and Only
Approved Therapy That Demonstrated
Superior PFS * vs rituximab in
Previously Untreated FL 1
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; 38-month median observation time.
†
Important Safety Information (cont’d)
Infusion Reactions (cont’d)
• 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
Infections (cont’d)
•
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
•
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
Infections
•
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
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
Immunization
•
The safety and effi cacy 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