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ETOPOSID EBEWE

Package(a):
VIAL: 1 x 100 mg/5 ml.
Dosage(a):
Concentrate to be diluted before use. Administer by slow infusion over 30 minutes to 2 hours. 
Adults: The recommended dose is 60-120 mg/m² I.V. per day for 5 subsequent days. As treatment causes myelosuppression, course of treatment must not be repeated more often than intervals of 21 days. Repeated courses of infusion must not be given before the blood picture has been controlled for signs of myelosuppression and found satisfactory. 
Pediatric patients: Safety and efficacy in children have not been established. 
Elderly: Dose adjustment is not necessary. 
Renal impairment: In patients with renal impairment but with normal hepatic function, the dose must be reduced and hematological minimum values and renal function must be monitored. Recommended daily dose based on creatinine clearance is as follows: >50 ml/min: 100% of standard dose. 15-50 ml/min: 75% of standard dose. <15 ml/min: Contraindicated.
Prescribing Restrictions:  None

Package(b):
VIAL: 1 x 200 mg/10 ml.
Dosage(b):
Concentrate to be diluted before use. Administer by slow infusion over 30 minutes to 2 hours. 
Adults: The recommended dose is 60-120 mg/m² I.V. per day for 5 subsequent days. As treatment causes myelosuppression, course of treatment must not be repeated more often than intervals of 21 days. Repeated courses of infusion must not be given before the blood picture has been controlled for signs of myelosuppression and found satisfactory. 
Pediatric patients: Safety and efficacy in children have not been established. 
Elderly: Dose adjustment is not necessary. 
Renal impairment: In patients with renal impairment but with normal hepatic function, the dose must be reduced and hematological minimum values and renal function must be monitored. Recommended daily dose based on creatinine clearance is as follows: >50 ml/min: 100% of standard dose. 15-50 ml/min: 75% of standard dose. <15 ml/min: Contraindicated.
Prescribing Restrictions:  None

Package(c):
VIAL: 1 x 1,000 mg/50 ml.
Dosage(c):
Concentrate to be diluted before use. Administer by slow infusion over 30 minutes to 2 hours. 
Adults: The recommended dose is 60-120 mg/m² I.V. per day for 5 subsequent days. As treatment causes myelosuppression, course of treatment must not be repeated more often than intervals of 21 days. Repeated courses of infusion must not be given before the blood picture has been controlled for signs of myelosuppression and found satisfactory. 
Pediatric patients: Safety and efficacy in children have not been established. 
Elderly: Dose adjustment is not necessary. 
Renal impairment: In patients with renal impairment but with normal hepatic function, the dose must be reduced and hematological minimum values and renal function must be monitored. Recommended daily dose based on creatinine clearance is as follows: >50 ml/min: 100% of standard dose. 15-50 ml/min: 75% of standard dose. <15 ml/min: Contraindicated.
Prescribing Restrictions:  None


Indications:
Alone or in combination with other cytostatic drugs in the treatment of small cell lung cancer or resistant non seminomatous testicular carcinoma. In combination with other chemotherapeutic drugs, in the treatment of Hodgkin’s and non Hodgkin’s lymphoma, acute myelocytic leukemia.
Contra-Indications:
Hypersensitivity, bone marrow depression, severe hepatic impairment, severe renal impairment, pregnancy and lactation. See prescribing information for full details.
Special Precautions:
Should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Should not be administered intra-arterially or intracavitarily (pleura, peritoneum or other cavities). When given by I.V., care should is advised in order to avoid extravasation. If radiation and/or chemotherapy is given before initiation of treatment, adequate intervals should be allowed to enable the bone marrow to recover. If the leukocyte level falls below 2,000/mm³ or the thrombocyte level is below 50,000/mm³, the treatment must be discontinued until the blood cells again have reached acceptable levels. Depending on whether used alone or as combination treatment, the blood levels regenerate typically within 21 days. Peripheral blood counts and hepatic function must be monitored. Bacterial infections must be brought under control before initiation of treatment. Anaphylactic reactions such as flush, tachycardia, bronchospasm and hypotension may occur. Car driving or handling of machines cannot be recommended shortly after treatment. See prescribing information for full details. 
Pregnancy and lactation: Should not be administered during pregnancy. Men treated with etoposide are advised to use appropriate contraceptive measures. Lactation should be discontinued during therapy.
Side Effects:
Myelosuppression, peripheral neuropathy, hypotension may occur after too rapid infusion, anaphylactic-like reactions, nausea and vomiting, reversible alopeica. See prescribing information for full details.
Drug Interactions:
Oral anticoagulants. Phenylbutazone, sodium salicylate and salicylic acid. Etoposide is usually used together with other cytotoxic drugs and synergistic effects are assumed to occur. Such a synergy has been documented in vitro for certain drugs, including methotrexate and cisplatin.