(Approval lasped) ENDOXAN Cyclophosphamide 50mg tablets

The proper use of cyclophosphamide requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy and continued evaluation of the patient's general and haematological status. It is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide. The clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. Careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk.

Antineoplastic Properties: Patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone. The following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide.

1. Frequently responsive myeloproliferative and lymphoproliferative disorders: malignant lymphomas (stages III and IV, Peter's Staging System*); multiple myeloma; leukaemias; mycosis fungoides (advanced disease). * Modified as the International Staging Classification for Hodgkin's Disease in "Report of the Committee on the Staging of Hodgkin's Disease." Cancer Res. 26, 1310, 1966. Stage I. Disease limited to one anatomic region (Stage I) or two contiguous anatomic regions (Stage I) on the same side of the diaphragm. Stage II. Disease in more than two anatomic regions or in two contiguous regions on the same side of the diaphragm. Stage III. Disease on both sides of the diaphragm, but not extending beyond the involvement of the lymph nodes, spleen and/or tonsils. Stage IV. Involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or any tissue or organ in addition to lymph nodes, spleen or tonsils. All stages are sub classified as A or B to indicate the absence or presence respectively of systemic symptoms.
2. Frequently responsive solid malignancies: neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary; retinoblastoma.
3. Infrequently responsive malignancies: carcinoma of the breast; malignant neoplasm of the lung.

Immunosuppressive Properties: Cyclophosphamide has been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. Wegener's granulomatosis) when these diseases have been resistant to the conventional first and second line treatment and for the prevention of transplant rejection.

Cyclophosphamide can be recommended for use in the treatment of non-malignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.