Cyclophosphamide

Cyclophosphamide may be used alone or in combination with other chemotherapeutic agents, depending on the indication. Cyclophosphamide Seacross is indicated in the treatment of: • Chronic Lymphocytic Leukaemia (CLL), • Acute Lymphocytic Leukaemia (ALL), • As conditioning for a bone marrow transplantation, in the treatment of Acute Lymphoblastic Leukaemia, Chronic Myelogenous Leukaemia and Acute Myelogenous Leukaemia in combination with whole body irradiation or busulfan, • Hodgkin's lymphoma, Non-Hodgkin's lymphoma and Multiple Myeloma, • Metastatic ovarian and breast, carcinoma, • Adjuvant treatment of breast carcinoma, • Ewing's sarcoma, • Small cell lung cancer, • advanced or metastatic neuroblastoma, • Life-threatening autoimmune diseases: severe progressive forms of lupus nephritis and Wegener’s granulomatosis.

Cyclophosphamide for Injection, used alone or as a component of combination therapy is indicated in adults for: A: Frequently responsive myeloproliferative and lymphoproliferative disorders 1. Malignant lymphomas (See also 4 DOSAGE AND ADMINISTRATION) a) Hodgkin's disease [Cotswold stages II & III (massive mediastinal disease) and IIIA1,2 - IV E] Non-Hodgkin's lymphomas (Working Formulation.

Low Grade A,B,C; Intermediate Grade D,E,F,G; High Grade H,I,J) b) Follicular lymphoma (B,C,D) c) Lymphocytic lymphoma (A,B,E; mixed histiocytic, C,F) ** Note: Type A, small diffuse and well differentiated malignant lymphocytic lymphoma is consistent with chronic lymphocytic leukemia, to be considered a heterogenous group of chronic B-cell disorders.

d) Diffuse histiocytic lymphoma (G,H) e) Lymphoblastic lymphoma (I) f) Burkitt's lymphoma (J) 2. Multiple Myelomas (Myeloma stages II, IIIA, IIIB) (See also 4 DOSAGE AND ADMINISTRATION) 3. Leukemias (See also 4 DOSAGE AND ADMINISTRATION) a) Chronic Lymphocytic Leukemia (CLL) (Rai Stages II, III, IV) (Binet Stages B, C) NOTE: Chronic lymphocytic leukemias are considered to be a heterogenous group of chronic B-cell disorders.

2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. 1 Malignant Diseases Cyclophosphamide for injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) adenocarcinoma of the ovary retinoblastoma carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs.