Active Ingredient: Aldesleukin
Aldesleukin is indicated for the treatment of metastatic renal cell carcinoma.
Risk factors associated with decreased response rates and median survival are:
* ECOG (Eastern Cooperative Oncology Group) 0 = normal activity, 1 = symptoms but ambulatory; 2 = in bed less than 50% of time; 3 = in bed more than 50% of time.
Response rates and median survival decrease with the number of risk factors present. Patients positive for all three risk factors should not be treated with aldesleukin.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
18,000,000 - 18,000,000 [iU]
From 18,000,000 To 18,000,000 [iU] once every day for 5 day(s)
18 × 106 IU as subcutaneous (s.c.) injection every day for 5 days, followed by 2 days rest. For the following 3 weeks 18 × 106 IU s.c. on days 1 and 2 of each week followed by 9 × 106 IU on days 3-5. On days 6 and 7 no treatment is administered. After 1 week rest this 4-week cycle should be repeated.
Maintenance: Maintenance cycles as described above may be given to patients who respond or have disease stabilisation.
If a patient cannot tolerate the recommended dosage regimen, the dose should be reduced or the administration interrupted until the toxicity has moderated. It is not known to what extent dose reduction affects response rates and median survival.
Elderly: Elderly patients may be more susceptible to the side effects of aldesleukin and caution is recommended in the treatment of such patients.
Day 1: 18000000 IU
Day 2: 18000000 IU
Day 3: 18000000 IU
Day 4: 18000000 IU
Day 5: 18000000 IU
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Day 8: 18000000 IU
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Intravenous
18,000,000 - 9,000,000 [iU] per m² of body surface area (BSA)
From 18,000,000 To 9,000,000 [iU] per m² of body surface area (BSA) once every day for 5 day(s)
18,000,000 [iU] per m² of body surface area (BSA)
9,000,000 [iU] per m² of body surface area (BSA)
18 × 106 IU per m² per 24-hours as a continuous infusion for 5 days, followed by 2-6 days without active substance, an additional 5 days of intravenous aldesleukin as a continuous infusion and 3 weeks without active substance. This constitutes one induction cycle. After the 3-week rest period of the first cycle, a second induction cycle should be given.
Maintenance: Up to four maintenance cycles (18 × 106 IU per m² as continuous infusion for 5 days) may be given with 4-week intervals to patients who respond or have disease stabilization.
Day 1: 18000000 IU
Day 2: 18000000 IU
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