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| GAZYVA for Previously Untreated Follicular Lymphoma |
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| Studied head-to-head vs rituximab* in stage II bulky, III, and IV patients1 |
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| Indication |
| GAZYVA,
in combination with chemotherapy followed by GAZYVA monotherapy in
patients achieving at least a partial remission, is indicated for the
treatment of adult patients with previously untreated stage II bulky,
III or IV follicular lymphoma (FL). |
| Important Safety Information |
| BOXED WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY |
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Hepatitis
B Virus (HBV) reactivation, in some cases resulting in fulminant
hepatitis, hepatic failure, and death, can occur in patients receiving
CD20-directed cytolytic antibodies, including GAZYVA. Screen all
patients for HBV infection before treatment initiation. Monitor HBV
positive patients during and after treatment with GAZYVA. Discontinue
GAZYVA and concomitant medications in the event of HBV reactivation |
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Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA |
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| Contraindications |
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GAZYVA
is contraindicated in patients with known hypersensitivity reactions
(e.g. anaphylaxis) to obinutuzumab or to any of the excipients, or serum
sickness with prior obinutuzumab use |
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| Additional Warnings and Precautions |
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Infusion Reactions:
GAZYVA can cause severe and life-threatening infusion reactions. Sixty
percent of patients with previously untreated NHL experienced a reaction
on Day 1 of GAZYVA infusion. For patients with Grade 4 infusion
reactions, including but not limited to anaphylaxis, acute
life-threatening respiratory symptoms, or other life-threatening
infusion reaction, stop and permanently discontinue GAZYVA therapy.
Premedicate patients with acetaminophen, an antihistamine, and a
glucocorticoid. Closely monitor patients during the entire infusion.
Infusion reactions within 24 hours of receiving GAZYVA have occurred.
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 |
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Hypersensitivity Reactions Including Serum Sickness:
Hypersensitivity reactions have been reported in patients treated with
GAZYVA. Late-onset hypersensitivity diagnosed as serum sickness has also
been reported in patients treated with GAZYVA. 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 |
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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 109/L)
or renal impairment are at greater risk for TLS and should receive
appropriate tumor lysis prophylaxis with antihyperuricemics and
hydration prior to the infusion of GAZYVA |
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Infections: Fatal and
serious bacterial, fungal, and new or reactivated viral infections can
occur during and following GAZYVA therapy. Do not administer GAZYVA to
patients with an active 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%) |
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Neutropenia: Severe and
life-threatening neutropenia can occur. Monitor patients with Grade 3 to
4 neutropenia frequently with regular laboratory tests until
resolution. Neutropenia can also be of late onset and/or prolonged |
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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 for thrombocytopenia. 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 |
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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 |
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| Additional Important Safety Information |
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A randomized,
open-label multicenter trial (GALLIUM) evaluated the safety of GAZYVA as
compared to rituximab product in 1,385 patients with previously
untreated follicular lymphoma (86%) or marginal zone lymphoma (14%) |
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Serious adverse reactions occurred in 50% of
patients on the GAZYVA arm and 43% of patients on the rituximab product
arm. Fatal adverse reactions were reported during treatment in 3% in
the GAZYVA arm and 2% in the rituximab product arm, most often from
infections in the GAZYVA arm. During treatment and follow-up combined,
fatal adverse reactions were reported in 5% of the GAZYVA arm and 4% of
the rituximab product arm, with infections and second malignancies being
leading causes. In the GAZYVA arm, fatal infections occurred in 2% of
patients compared to <1% in the rituximab product arm |
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Neutropenia, infusion related reactions,
febrile neutropenia and thrombocytopenia were the most common Grade 3 to
5 adverse reactions (incidence ≥5%) observed more frequently in the
GAZYVA arm |
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Throughout treatment and follow-up, the most
common adverse reactions (incidence ≥20%) observed at least 2% more in
the GAZYVA arm were infusion related reactions, neutropenia, upper
respiratory tract infection, cough, constipation and diarrhea |
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During the monotherapy period, the common
adverse reactions (incidence ≥10%) observed at least 2% more with GAZYVA
were upper respiratory infection (40%), cough (23%), musculoskeletal
pain (20%), neutropenia (19%) and herpesvirus infection (13%) |
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| 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. |
| Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS. |
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