Active Ingredient: Vinflunine
Vinflunine is indicated in monotherapy for the treatment of elderly 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
250 - 320 mg per m² of body surface area (BSA)
From 250 To 320 mg per m² of body surface area (BSA) once every 21 day(s)
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.
No age-related dose modification is required in patients less than 75 years old.
The doses recommended in patients of at least 75 years old are as follows:
For further cycles, the dose should be adjusted in the event of toxicities, as shown in the table below.
Dose adjustments due to toxicity in renal impaired or elderly patients:
| Toxicity | Dose adjustment | |||
|---|---|---|---|---|
| (NCI CTC v 2.0)* | Vinflunine initial dose of 280 mg/m² | Vinflunine initial dose of 250 mg/m² | ||
| First Event | 2° consecutive event | First Event | 2° consecutive event | |
| Neutropenia Grade 4 (ANC <500/mm³) > 7 ημέρες | 250 mg/m² | Definitive Treatment discontinuation | 225 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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