ASH News Daily 2017 - Issue 3 - A-6
IMPORTANT SAFETY INFORMATION (CONT'D)
ADDITIONAL WARNINGS AND PRECAUTIONS
Hypersensitivity and Other Administration Reactions
Systemic Reactions
ê Patients must receive at least one full dose of RITUXAN before receiving RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute
reactions during the first infusion. Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by
slowing or stopping the intravenous infusion
ê Rituximab-containing products, including RITUXAN HYCELA, are associated with hypersensitivity and other administration reactions. This set of
reactions includes syndrome of cytokine release, tumor lysis syndrome, and anaphylactic and hypersensitivity reactions. They are not specifically
related to the route of administration of a rituximab-containing product
ê Severe infusion-related reactions with fatal outcome have been reported with the use of RITUXAN, with an onset of 30 minutes to 2 hours
after starting the first infusion. Anaphylactic and other hypersensitivity reactions can also occur. In contrast to cytokine release syndrome, true
hypersensitivity reactions typically occur within minutes after starting infusion
ê Cytokine release syndrome may occur within 1-2 hours of initiating the infusion. Patients with a history of pulmonary insufficiency or those with
pulmonary tumor infiltration may be at a greater risk of poor outcome. Rituximab product administration should be interrupted immediately and
aggressive symptomatic treatment initiated
ê Interrupt RITUXAN HYCELA administration immediately when observing signs of a severe reaction and initiate aggressive symptomatic treatment.
Closely monitor: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and
those with high numbers of circulating malignant cells (≥25,000/mm3)
ê Premedicate patients with an antihistamine and acetaminophen and consider glucocorticoids prior to each administration of RITUXAN HYCELA.
Observe patients for at least 15 minutes following RITUXAN HYCELA. A longer period may be appropriate in patients with an increased risk of
hypersensitivity reactions
Local Cutaneous Reactions
ê Local cutaneous reactions, including injection site reactions, have been reported in patients receiving RITUXAN HYCELA
Tumor Lysis Syndrome (TLS)
ê TLS can occur within 12-24 hours after administration of a rituximab-containing product, including RITUXAN HYCELA. Administer aggressive
intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function
and fluid balance, and administer supportive care, including dialysis, as indicated
Infections
ê Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy with
rituximab-containing products, including RITUXAN HYCELA. Discontinue RITUXAN HYCELA for serious infections and institute appropriate antiinfective therapy
Cardiovascular Adverse Reactions
ê Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock, may occur with rituximab-containing
products, including RITUXAN HYCELA. Discontinue RITUXAN HYCELA for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring
during and after all administrations of RITUXAN HYCELA for patients who develop clinically significant arrhythmias, or who have a history of
arrhythmia or angina
Renal Toxicity
ê Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA. Monitor closely
for signs of renal failure and discontinue RITUXAN HYCELA in patients with a rising serum creatinine or oliguria
Bowel Obstruction and Perforation
ê Abdominal pain, bowel obstruction, and perforation, in some cases leading to death, can occur in patients receiving rituximab-containing products,
including RITUXAN HYCELA, in combination with chemotherapy
Immunization
ê The safety of immunization with live viral vaccines following rituximab-containing products, including RITUXAN HYCELA, has not been studied and
vaccination with live virus vaccines is not recommended before or during treatment
Embryo-Fetal Toxicity
ê Based on human data, rituximab-containing products can cause fetal harm. Advise pregnant women of the risk to a fetus. Females of childbearing
potential should use effective contraception while receiving RITUXAN HYCELA and for 12 months following the last dose of rituximab-containing
products, including RITUXAN HYCELA
ADVERSE REACTIONS
ê The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with FL in SABRINA were: infections, neutropenia, nausea,
constipation, cough, and fatigue
ê The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with DLBCL in MabEASE were: infections, neutropenia,
alopecia, nausea, and anemia
ê The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with CLL in part 2 of SAWYER were: infections, neutropenia,
nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema
Please see the following pages for the brief summary of the full Prescribing Information, including BOXED WARNINGS, for additional
Important Safety Information.
Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN HYCELA treatment.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech
at (888) 835-2555.
To learn more, visit RITUXANHYCELA.com/hcp
© 2017 Genentech USA, Inc. and Biogen. All rights reserved. RSC/091217/0069 Printed in USA. December 2017
Jointly Marketed by: Biogen and Genentech USA, Inc. RITUXAN® is a registered trademark of Biogen and
RITUXAN HYCELA™ is a trademark of Biogen.
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10/6/17 2:27 PM
Table of Contents for the Digital Edition of ASH News Daily 2017 - Issue 3
ASH News Daily 2017 - Issue 3 - A-1
ASH News Daily 2017 - Issue 3 - A-2
ASH News Daily 2017 - Issue 3 - A-3
ASH News Daily 2017 - Issue 3 - A-4
ASH News Daily 2017 - Issue 3 - A-5
ASH News Daily 2017 - Issue 3 - A-6
ASH News Daily 2017 - Issue 3 - A-7
ASH News Daily 2017 - Issue 3 - A-8
ASH News Daily 2017 - Issue 3 - A-9
ASH News Daily 2017 - Issue 3 - A-10
ASH News Daily 2017 - Issue 3 - A-11
ASH News Daily 2017 - Issue 3 - A-12
ASH News Daily 2017 - Issue 3 - A-13
ASH News Daily 2017 - Issue 3 - A-14
ASH News Daily 2017 - Issue 3 - A-15
ASH News Daily 2017 - Issue 3 - A-16
ASH News Daily 2017 - Issue 3 - A-17
ASH News Daily 2017 - Issue 3 - A-18
ASH News Daily 2017 - Issue 3 - A-19
ASH News Daily 2017 - Issue 3 - A-20
ASH News Daily 2017 - Issue 3 - A-21
ASH News Daily 2017 - Issue 3 - A-22
ASH News Daily 2017 - Issue 3 - A-23
ASH News Daily 2017 - Issue 3 - A-24
ASH News Daily 2017 - Issue 3 - A-25
ASH News Daily 2017 - Issue 3 - A-26
ASH News Daily 2017 - Issue 3 - A-27
ASH News Daily 2017 - Issue 3 - A-28
ASH News Daily 2017 - Issue 3 - B-1
ASH News Daily 2017 - Issue 3 - B-2
ASH News Daily 2017 - Issue 3 - B-3
ASH News Daily 2017 - Issue 3 - B-4
ASH News Daily 2017 - Issue 3 - B-5
ASH News Daily 2017 - Issue 3 - B-6
ASH News Daily 2017 - Issue 3 - B-7
ASH News Daily 2017 - Issue 3 - B-8
ASH News Daily 2017 - Issue 3 - B-9
ASH News Daily 2017 - Issue 3 - B-10
ASH News Daily 2017 - Issue 3 - B-11
ASH News Daily 2017 - Issue 3 - B-12
ASH News Daily 2017 - Issue 3 - B-13
ASH News Daily 2017 - Issue 3 - B-14
ASH News Daily 2017 - Issue 3 - B-15
ASH News Daily 2017 - Issue 3 - B-16
ASH News Daily 2017 - Issue 3 - B-17
ASH News Daily 2017 - Issue 3 - B-18
ASH News Daily 2017 - Issue 3 - B-19
ASH News Daily 2017 - Issue 3 - B-20
ASH News Daily 2017 - Issue 3 - B-21
ASH News Daily 2017 - Issue 3 - B-22
ASH News Daily 2017 - Issue 3 - B-23
ASH News Daily 2017 - Issue 3 - B-24
ASH News Daily 2017 - Issue 3 - B-25
ASH News Daily 2017 - Issue 3 - B-26
ASH News Daily 2017 - Issue 3 - B-27
ASH News Daily 2017 - Issue 3 - B-30
ASH News Daily 2017 - Issue 3 - B-31
ASH News Daily 2017 - Issue 3 - B-32
ASH News Daily 2017 - Issue 3 - B-33
ASH News Daily 2017 - Issue 3 - B-34
ASH News Daily 2017 - Issue 3 - B-35
ASH News Daily 2017 - Issue 3 - B-36
ASH News Daily 2017 - Issue 3 - B-37
ASH News Daily 2017 - Issue 3 - B-38
ASH News Daily 2017 - Issue 3 - B-39
ASH News Daily 2017 - Issue 3 - B-40
ASH News Daily 2017 - Issue 3 - B-41
ASH News Daily 2017 - Issue 3 - B-42
ASH News Daily 2017 - Issue 3 - B-43
ASH News Daily 2017 - Issue 3 - B-44
ASH News Daily 2017 - Issue 3 - B-45
ASH News Daily 2017 - Issue 3 - B-46
ASH News Daily 2017 - Issue 3 - B-47
ASH News Daily 2017 - Issue 3 - B-48
ASH News Daily 2017 - Issue 3 - B-49
ASH News Daily 2017 - Issue 3 - B-50
ASH News Daily 2017 - Issue 3 - B-51
ASH News Daily 2017 - Issue 3 - B-52
ASH News Daily 2017 - Issue 3 - B-53
ASH News Daily 2017 - Issue 3 - B-54
ASH News Daily 2017 - Issue 3 - B-55
ASH News Daily 2017 - Issue 3 - B-56
ASH News Daily 2017 - Issue 3 - C-1
ASH News Daily 2017 - Issue 3 - C-2
ASH News Daily 2017 - Issue 3 - C-3
ASH News Daily 2017 - Issue 3 - C-4
ASH News Daily 2017 - Issue 3 - C-5
ASH News Daily 2017 - Issue 3 - C-6
ASH News Daily 2017 - Issue 3 - C-7
ASH News Daily 2017 - Issue 3 - C-8
ASH News Daily 2017 - Issue 3 - C-9
ASH News Daily 2017 - Issue 3 - C-10
ASH News Daily 2017 - Issue 3 - C-11
ASH News Daily 2017 - Issue 3 - C-12
ASH News Daily 2017 - Issue 3 - C-13
ASH News Daily 2017 - Issue 3 - C-14
ASH News Daily 2017 - Issue 3 - C-15
ASH News Daily 2017 - Issue 3 - C-16
ASH News Daily 2017 - Issue 3 - C-17
ASH News Daily 2017 - Issue 3 - C-18
ASH News Daily 2017 - Issue 3 - C-19
ASH News Daily 2017 - Issue 3 - C-20
ASH News Daily 2017 - Issue 3 - C-21
ASH News Daily 2017 - Issue 3 - C-22
ASH News Daily 2017 - Issue 3 - C-23
ASH News Daily 2017 - Issue 3 - C-24
ASH News Daily 2017 - Issue 3 - C-25
ASH News Daily 2017 - Issue 3 - C-26
ASH News Daily 2017 - Issue 3 - C-27
ASH News Daily 2017 - Issue 3 - C-28
ASH News Daily 2017 - Issue 3 - C-29
ASH News Daily 2017 - Issue 3 - C-30
ASH News Daily 2017 - Issue 3 - C-31
ASH News Daily 2017 - Issue 3 - C-32
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