Active Ingredient: Etoposide
Etoposide is indicated in combination with other approved chemotherapeutic agents for the treatment of acute myeloid leukaemia in adult and paediatric patients.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
50 - 100 mg per m² of body surface area (BSA)
From 50 To 100 mg per m² of body surface area (BSA) once every day for 5 day(s)
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 drugs indicated in the disease to be treated. Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy 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.
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.
No dosage adjustment is necessary in elderly patients (age >65 years old), other than based on renal function.
Etoposide phosphate is administered by slow intravenous infusion (usually over a 30 to 60 minute period).
Intravenous
100 - 120 mg per m² of body surface area (BSA)
From 100 To 120 mg per m² of body surface area (BSA) once every 2 day(s) for 6 day(s)
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 drugs indicated in the disease to be treated. Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy 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.
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.
No dosage adjustment is necessary in elderly patients (age >65 years old), other than based on renal function.
Etoposide phosphate is administered by slow intravenous infusion (usually over a 30 to 60 minute period).
Oral
100 - 200 mg per m² of body surface area (BSA)
From 100 To 200 mg per m² of body surface area (BSA) once every day for 5 day(s)
The dose of etoposide is based on the recommended intravenous dose taking into account the dose-dependent bioavailability of etoposide. A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose. Within-patient variability in exposure (i.e. between cycles) is larger with oral administration than after intravenous administration.
The usual dose of etoposide administered orally is 100 to 200 mg/m²/day on days 1 to 5 or 200 mg/m²/day on days 1, 3 and 5 every 3 to 4 weeks. Daily doses greater than 200 mg should be divided and given twice per day.
The usual dose of etoposide administered orally is 100 to 200 mg/m²/day on days 1 to 5 or 200 mg/m²/day on days 1, 3 and 5 every 3 to 4 weeks in combination with other drugs approved for use in the disease to be treated.
Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy, 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.
An alternative dosage schedule for etoposide is 50 mg/m²/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Patients should not begin a new cycle of treatment with etoposide if the neutrophil count is less than 1,500 cells/mm³ or the platelet count is less than 100,000 cells/mm³, unless caused by malignant disease.
No dosage adjustment is necessary in elderly patients (age >65 years old), other than based on renal function.
It should be taken on an empty stomach.
Oral
200 - 200 mg per m² of body surface area (BSA)
From 200 To 200 mg per m² of body surface area (BSA) once every 2 day(s) for 6 day(s)
The dose of etoposide is based on the recommended intravenous dose taking into account the dose-dependent bioavailability of etoposide. A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose. Within-patient variability in exposure (i.e. between cycles) is larger with oral administration than after intravenous administration.
The usual dose of etoposide administered orally is 100 to 200 mg/m²/day on days 1 to 5 or 200 mg/m²/day on days 1, 3 and 5 every 3 to 4 weeks. Daily doses greater than 200 mg should be divided and given twice per day.
The usual dose of etoposide administered orally is 100 to 200 mg/m²/day on days 1 to 5 or 200 mg/m²/day on days 1, 3 and 5 every 3 to 4 weeks in combination with other drugs approved for use in the disease to be treated.
Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy, 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.
An alternative dosage schedule for etoposide is 50 mg/m²/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
Patients should not begin a new cycle of treatment with etoposide if the neutrophil count is less than 1,500 cells/mm³ or the platelet count is less than 100,000 cells/mm³, unless caused by malignant disease.
No dosage adjustment is necessary in elderly patients (age >65 years old), other than based on renal function.
It should be taken on an empty stomach.
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