Active Ingredient: Paclitaxel
Paclitaxel in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
125 - 125 mg per m² of body surface area (BSA)
From 125 To 125 mg per m² of body surface area (BSA) once every 7 day(s) for 15 day(s)
The recommended dose of paclitaxel in combination with gemcitabine is 125 mg/m² administered intravenously over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. The concurrent recommended dose of gemcitabine is 1000 mg/m² administered intravenously over 30 minutes immediately after the completion of paclitaxel administration on Days 1, 8 and 15 of each 28-day cycle.
Dose level reductions for patients with pancreatic adenocarcinoma:
| Dose Level | Paclitaxel Dose (mg/m²) | Gemcitabine Dose (mg/m²) |
|---|---|---|
| Full dose | 125 | 1000 |
| 1st dose level reduction | 100 | 800 |
| 2nd dose level reduction | 75 | 600 |
| If additional dose reduction required | Discontinue treatment | Discontinue treatment |
Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma:
Dose modifications for other adverse drug reactions in patients with pancreatic adenocarcinoma:
| Adverse Drug Reaction (ADR) | Abraxane Dose | Gemcitabine Dose |
|---|---|---|
| Febrile Neutropenia: Grade 3 or 4 | Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela | |
| Peripheral Neuropathy: Grade 3 or 4 | Withhold dose until improves to ≤ Grade 1; resume at next lower dose levela | Treat with same dose |
| Cutaneous Toxicity: Grade 2 or 3 | Reduce to next lower dose levela; discontinue treatment if ADR persists | |
| Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea | Withhold doses until improves to ≤ Grade 1; resume at next lower dose levela | |
a See table “Dose level reductions for patients with pancreatic adenocarcinoma” for dose level reductions
Administered intravenously over 30 minutes.
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