Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, SUGAR COATED
**Posology and method of administration** ENDOXAN should only be administered by experienced oncologists. The dosage must be adapted to each patient individually. Unless otherwise prescribed the following dosages are recommended: ENDOXAN, sugar-coated tablets: For continuous therapy 1–4 tablets (50–200 mg) daily; if necessary, more tablets may be taken. The dose recommendations given mainly apply to the treatment with cyclophosphamide as a monotherapy. In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy-free intervals may be necessary. _Recommendations for dose reduction in patients with myelosuppression_  _Recommendations for dose adjustment in patients with hepatic and renal insufficiency_ Severe hepatic or renal insufficiency requires a dose reduction. A dose reduction of 25% for serum bilirubin from 3.1 to 5 mg/100 ml and of 50% for a glomerular filtration rate below 10 ml/minute is recommended. Cyclophosphamide is dialysable. ENDOXAN, sugar-coated tablets ENDOXAN sugar-coated tablets should be administered in the morning. During or immediately after the administration adequate amounts of fluid should be ingested. It is important to ensure that the patient empties his/her bladder at regular intervals. Duration of therapy and intervals will depend on the indication, the applied combination chemotherapy schedule, the patient's general state of health, the laboratory parameters and the recovery of blood cell counts. **Instructions for use and handling** The handling and preparation of ENDOXAN should always be in accordance with the safety precautions used for handling of cytotoxic agents.
ORAL
Medical Information
**Therapeutic Indications** ENDOXAN is used within a combination chemotherapy regimen or as monotherapy in Leukaemias: acute or chronic lymphocytic and myelogenous leukaemias Malignant lymphomas: Hodgkin's disease, non-Hodgkin's lymphomas, plasmacytoma Metastasizing and non-metastasizing malignant solid tumours: ovarian cancer, testicular cancer, breast cancer, small cell lung cancer, neuroblastoma, Ewing's sarcoma Progressive “autoimmune diseases”: e.g. rheumatoid arthritis, psoriatic arthropathy, systemic lupus erythematosus, scleroderma, systemic vasculitides (e.g. with nephrotic syndrome), certain types of glomerulonephritis (e.g. with nephrotic syndrome), myasthenia gravis, autoimmune haemolytic anaemia, cold agglutinin diseases. Immunosuppressive treatment in organ transplantations
**Contraindications** ENDOXAN should not be used in patients with: - known hypersensitivity to cyclophosphamide - severely impaired bone-marrow function (particular in patients who have been pre-treated with cytotoxic agents and/or radiotherapy) - inflammation of the bladder (cystitis) - urinary outflow obstructions - active infections Endoxan should not be used in pregnancy and lactation (see pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
L01AA01
cyclophosphamide
Manufacturer Information
BAXTER HEALTHCARE (ASIA) PTE LTD
Prasfarma S. L.
Haupt Pharma Amareg GmbH
Active Ingredients
Documents
Package Inserts
Endoxan tablet PI.pdf
Approved: April 8, 2019