Advanced gastric cancer, gastro-oesophageal junction adenocarcinoma

Active Ingredient: Ramucirumab

Indication for Ramucirumab

Population group: only adults (18 years old or older)

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:

8 mg/kg once every 2 weeks

Route of admnistration

Intravenous

Defined daily dose

8 - 8 mg per kg of body weight

Dosage regimen

From 8 To 8 mg per kg of body weight once every 15 day(s)

Detailed description

Ramucirumab in combination with paclitaxel

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
NeutrophilsDay 1: ≥1.5 × 109/l, Days 8 and 15: ≥1.0 × 109/l
PlateletsDay 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

Ramucirumab as a single agent

The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.

Active ingredient

Ramucirumab

Ramucirumab is a human receptor-targeted antibody that specifically binds VEGF Receptor 2 and blocks binding of VEGF-A, VEGF-C, and VEGF-D. Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis. As a result, ramucirumab inhibits ligand stimulated activation of VEGF Receptor 2 and its downstream signalling components, including p44/p42 mitogen-activated protein kinases, neutralising ligand-induced proliferation and migration of human endothelial cells.

Read more about Ramucirumab

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