Etoposid Ebewe

Etoposid Ebewe Dosage/Direction for Use

etoposide

Manufacturer:

EBEWE Pharma

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Full Prescribing Info
Dosage/Direction for Use
Etoposide should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products (see Precautions).
Adult population: The recommended dose of etoposide in adult patients is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4 weeks in combination with other medicinal products indicated in the disease to be treated. Dose should be modified to take into account the myelosuppressive effects of other medicinal products in the combination or the effects of prior radiotherapy or chemotherapy (see Precautions) which may have compromised bone marrow reserve.
The doses after the initial dose should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days. In addition the dose should be adjusted in case of occurrence of fever, infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease. Follow up doses should be adjusted in case of occurrence of grade 3 or 4 toxicities or if renal creatinine clearance is below 50 ml/min. At decreased creatinine clearance of 15 to 50 ml/min a dose reduction by 25% is recommended.
Administration precautions: As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of etoposide. Skin reactions associated with accidental exposure to etoposide may occur. The use of gloves is recommended. If etoposide solution contacts the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water (see Special precautions for disposal and other handling under Cautions for Usage).
Elderly population: No dose adjustment is necessary in elderly patients (age >65 years old), other than based on renal function (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: Hodgkin's lymphoma; non-Hodgkin's lymphoma; acute myeloid leukaemia: Etoposide in paediatric patients has been used in the range of 75 to 150 mg/m2/day (etoposide equivalent) for 2 to 5 days in combination with other antineoplastic agents. The treatment regimen should be chosen according to the local standard of care.
Ovarian cancer; small cell lung cancer; gestational trophoblastic neoplasia; testicular cancer: The safety and efficacy of etoposide below 18 years of age have not been established. Currently available data are described in Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Renal impairment: In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance. (See table.)

Click on icon to see table/diagram/image

In patients with creatinine clearance less than 15 ml/min and on dialysis further dose reduction is likely to be required as etoposide clearance is further reduced in these patients (see Precautions).
Subsequent dosing in moderate and severe renal impairment should be based on patient tolerance and clinical effect (see Precautions). Since etoposide and its metabolites are not dialysable, it can be administered pre- and post-haemodialysis (see Overdosage).
Method of administration: Etoposide is administered by slow intravenous infusion (usually over a 30 to 60 minute period) (see Precautions).
For instructions on reconstitution and dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
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