ENDOXAN TABLET 50 mg

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)

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.