cyclophosphamide
Drug Details
- Generic Name
- cyclophosphamide
- Brand Names
- CYCLOPHOSPHAMIDE, Cyclophosphamide
- Application Number
- ANDA040745
- Sponsor
- Baxter Healthcare Corporation
- NDC Codes
- 45
- Dosage Forms
- INJECTION, POWDER, FOR SOLUTION, INJECTION, SOLUTION, POWDER
- Routes
- INTRAVENOUS, ORAL
- Active Ingredients
- CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE ANHYDROUS
Indications and Usage
1 INDICATIONS AND USAGE Cyclophosphamide for Injection is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Disease s: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. ( 1.2 ) 1.1 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. 1.2 Minimal Change Nephrotic Syndrome in Pediatric Patients Cyclophosphamide for Injection is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatric patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy. Limitations of Use: The safety and effectiveness of Cyclophosphamide for Injection for the treatment of nephrotic syndrome in adults or other renal disease has not been established.