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1 Indications And Usage Rituxan Hycela Is A Combination Of Rituximab, A Cd20-Directed Cytolytic Antibody, And Hyaluronidase Human, An Endoglycosidase, Indicated For The Treatment Of Adult Patients With: Follicular Lymphoma (Fl) ( 1.1 ) Relapsed Or Refractory, Follicular Lymphoma As A Single Agent Previously Untreated Follicular Lymphoma In Combination With First Line Chemotherapy And, In Patients Achieving A Complete Or Partial Response To Rituximab In Combination With Chemotherapy, As Single-Agent Maintenance Therapy Non-Progressing (Including Stable Disease), Follicular Lymphoma As A Single Agent After First-Line Cyclophosphamide, Vincristine, And Prednisone (Cvp) Chemotherapy Diffuse Large B-Cell Lymphoma (Dlbcl) ( 1.2 ) Previously Untreated Diffuse Large B-Cell Lymphoma In Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (Chop) Or Other Anthracycline-Based Chemotherapy Regimens Chronic Lymphocytic Leukemia (Cll) ( 1.3 ) Previously Untreated And Previously Treated Cll In Combination With Fludarabine And Cyclophosphamide (Fc) Limitations Of Use: Initiate Treatment With Rituxan Hycela Only After Patients Have Received At Least One Full Dose Of A Rituximab Product By Intravenous Infusion. ( 1.4 , 2.1 , 5.4 ). Rituxan Hycela Is Not Indicated For The Treatment Of Non-Malignant Conditions. ( 1.4 ) 1.1 Follicular Lymphoma (Fl) Rituxan Hycela Is Indicated For The Treatment Of Adult Patients With: Relapsed Or Refractory, Follicular Lymphoma As A Single Agent. Previously Untreated Follicular Lymphoma In Combination With First Line Chemotherapy And, In Patients Achieving A Complete Or Partial Response To Rituximab In Combination With Chemotherapy, As Single-Agent Maintenance Therapy. Non-Progressing (Including Stable Disease), Follicular Lymphoma As A Single Agent After First-Line Cyclophosphamide, Vincristine, And Prednisone (Cvp) Chemotherapy. 1.2 Diffuse Large B-Cell Lymphoma (Dlbcl) Rituxan Hycela Is Indicated For The Treatment Of Adult Patients With Previously Untreated Diffuse Large B-Cell Lymphoma In Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (Chop) Or Other Anthracycline-Based Chemotherapy Regimens. 1.3 Chronic Lymphocytic Leukemia (Cll) Rituxan Hycela Is Indicated, In Combination With Fludarabine And Cyclophosphamide (Fc), For The Treatment Of Adult Patients With Previously Untreated And Previously Treated Cll. 1.4 Limitations Of Use Initiate Treatment With Rituxan Hycela Only After Patients Have Received At Least One Full Dose Of A Rituximab Product By Intravenous Infusion [See Dosage And Administration (2.1) And Warnings And Precautions (5.4) ]. Rituxan Hycela Is Not Indicated For The Treatment Of Non-Malignant Conditions.
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