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/mm 3 )
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 aft