ASH Clinical News July 2017 V2 - 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 respiratory tract infectio ns (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. Images in this advertisement do not depict actual patients or healthcare providers. Visit GAZYVA.com for more information © 2017 Genentech USA, Inc. All rights reserved. GAZ/021517/0006b Printed in USA. April 2017