Active Ingredient: Vinflunine
Vinflunine is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
280 - 320 mg per m² of body surface area (BSA)
From 280 To 320 mg per m² of body surface area (BSA) once every 21 day(s)
280 mg per m² of body surface area (BSA)
The recommended dose is 320 mg/m² vinflunine as a 20 minute intravenous infusion every 3 weeks.
In case of WHO/ECOG performance status (PS) of 1 or PS of 0 and prior pelvic irradiation, the treatment should be started at the dose of 280 mg/m². In the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dose will be increased to 320 mg/m² every 3 weeks for the subsequent cycles.
In order to prevent constipation, laxatives and dietary measures including oral hydration are recommended from day 1 to day 5 or 7 after each vinflunine administration.
Table 1. Dose delay for subsequent cycles due to toxicity:
| Toxicity | Day 1 treatment administration |
|---|---|
| Neutropenia (ANC <1000/mm³) or Thrombocytopenia (platelets <100.000/mm³) | Delay until recovery (ANC ≥1.000/mm³ and platelets ≥100.000/mm³) and adjust the dose if necessary (see table 2). Discontinuation if recovery has not occurred within 2 weeks |
| Organ toxicity: moderate, severe or life threatening | Delay until recovery to mild toxicity or none, or to initial baseline status and adjust the dose if necessary (see table 2). Discontinuation if recovery has not occurred within 2 weeks |
| Cardiac ischaemia in patients with prior history of myocardial infarction or angina pectoris | Discontinuation |
Table 2. Dose adjustments due to toxicity:
| Toxicity | Dose adjustment | ||||
|---|---|---|---|---|---|
| (NCI CTC v 2.0)* | Vinflunine initial dose of 320 mg/m² | Vinflunine initial dose of 280 mg/m² | |||
| First Event | 2° consecutive event | 3° consecutive event | First Event | 2° consecutive event | |
| Neutropenia Grade 4 (ANC <500/mm³) >7 days | 280 mg/m² | 250 mg/m² | Definitive Treatment discontinuation | 250 mg/m² | Definitive Treatment discontinuation |
| Febrile Neutropenia (ANC <1.000/mm³ and fever ≥38,5°C) | |||||
| Mucositis or Constipation Grade 2 ≥ 5 days or Grade ≥ 3 any duration1 | |||||
| Any other toxicity Grade ≥ 3 (severe or life-threatening) (except Grade 3 vomiting or nausea2) | |||||
* National Cancer Institute, Common Toxicity Criteria Version 2.0 (NCI CTC v 2.0)
1 NCI CTC Grade 2 constipation is defined as requiring laxatives, Grade 3 as an obstipation requiring manual evacuation or enema, Grade 4 as an obstruction or toxic megacolon. Mucositis Grade 2 is defined as “moderate”, Grade 3 as “severe” and Grade 4 as “life-threatening”.
2 NCI CTC Grade 3 nausea is defined as no significant intake, requiring intravenous fluids. Grade 3 vomiting as ≥6 episodes in 24 hours over pretreatment; or need for intravenous fluids.
Vinflunine should be administered by a 20-minute intravenous infusion and NOT be given by rapid intravenous bolus.
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