Active Ingredient: Ramucirumab
Ramucirumab in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.
Ramucirumab monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
8 - 8 mg per kg of body weight
From 8 To 8 mg per kg of body weight once every 15 day(s)
The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion. The recommended dose of paclitaxel is 80 mg/m² administered by intravenous infusion over approximately 60 minutes on days 1, 8 and 15 of a 28 day cycle. Prior to each paclitaxel infusion, patients should have a complete blood count and blood chemistry performed to evaluate hepatic function. Criteria to be met prior to each paclitaxel infusion are provided in the following table.
Criteria to be met prior to each paclitaxel administration:
| Criteria | |
|---|---|
| Neutrophils | Day 1: ≥1.5 × 109/l, Days 8 and 15: ≥1.0 × 109/l |
| Platelets | Day 1: ≥100 × 109/l, Days 8 and 15: ≥75 × 109/l |
| Bilirubin | ≤1.5 x upper limit of normal value (ULN) |
| Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) | No liver metastases: ALT/AST ≤3 x ULN, Liver metastases: ALT/AST ≤5 x ULN |
The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
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