ASH Clinical News May 2017 NEW | Page 3

IMPORTANT SAFETY INFORMATION (CONT’D)
Additional Warnings and Precautions
• Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions. Thirty-eight percent of patients
experienced a reaction on Day 1 during treatment with GAZYVA in combination with bendamustine. 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. For Grades 1, 2, or 3 infusion reactions, interrupt or
discontinue infusion for reactions
• 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 and hydration prior
to the infusion of GAZYVA
• Infections: Serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA
therapy. Fatal infections have been reported. Do not administer GAZYVA to patients with an active infection
• 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
• Thrombocytopenia: Severe and life-threatening thrombocytopenia has been reported during treatment with
GAZYVA in combination with bendamustine. Monitor all patients for thrombocytopenia. In patients with Grade 3 or
4 thrombocytopenia, monitor platelet counts and bleeding frequently until resolution and consider dose delays of
GAZYVA and bendamustine or dose reductions of bendamustine. Management of hemorrhage may require blood
product support
Additional Important Safety Information
• The safety of GAZYVA was evaluated based on a safety population of 392 patients with indolent NHL (iNHL), of whom
81% had follicular lymphoma. In patients with follicular lymphoma, the most common adverse reactions that were seen
were consistent with the overall population who had iNHL
• Grade 3/4 adverse reactions were: neutropenia (33%), infusion reactions (11%), thrombocytopenia (10%), urinary
tract infection (3%), upper respiratory tract infection (2%), pyrexia (1%), asthenia (1%), sinusitis (1%), and pain in
extremity (1%)
• The most common adverse reactions (incidence ≥10%) were: infusion reactions (69%), neutropenia (35%), nausea
(54%), fatigue (39%), cough (26%), diarrhea (27%), constipation (19%), pyrexia (18%), thrombocytopenia (15%),
vomiting (22%), upper respiratory tract infection (13%), decreased appetite (18%), arthralgia (12%), sinusitis (12%),
anemia (12%), asthenia (11%), and urinary tract infection (10%)
• During the monotherapy period with GAZYVA, the most common Grade 3-4 adverse reactions were neutropenia
(10%), and anemia, febrile neutropenia, thrombocytopenia, sepsis, upper respiratory tract infection, and urinary tract
infection (all at 1%)
• During the monotherapy period with GAZYVA, the most common adverse reactions were cough (15%), upper
respi ratory tract infections (12%), neutropenia (11%), sinusitis (10%), diarrhea (8%), infusion related reactions (8%),
nausea (8%), fatigue (8%), bronchitis (7%), arthralgia (7%), pyrexia (6%), nasopharyngitis (6%), and urinary tract
infections (6%)
You are encouraged to report side eff ects 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 following pages for the brief summary of the full Prescribing Information, including
Boxed WARNINGS.
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© 2017 Genentech USA, Inc. All rights reserved. GAZ/021517/0006b Printed in USA. April 2017