Cyramza

Gastric or gastroesophageal junction (GEJ) adenocarcinoma (as single agent or with paclitaxel, after prior fluoropyrimidine- or platinum-containing chemotherapy); Metastatic non-small cell lung cancer (with docetaxel, after progression on platinum-based chemotherapy; with erlotinib first-line for EGFR exon 19 deletions or exon 21 L858R mutations); Metastatic colorectal cancer (with FOLFIRI, after progression on bevacizumab/oxaliplatin/fluoropyrimidine); Hepatocellular carcinoma (as single agent with AFP ≥400 ng/mL, after prior sorafenib)

Gastric/GEJ (single agent): 8 mg/kg IV every 2 weeks
Gastric/GEJ (with paclitaxel): 8 mg/kg IV on Days 1 and 15 of 28-day cycle
NSCLC (with docetaxel): 10 mg/kg IV on Day 1 of 21-day cycle
CRC (with FOLFIRI): 8 mg/kg IV every 2 weeks
HCC: 8 mg/kg IV every 2 weeks
Infusion time: Approximately 60 minutes; do not exceed 25 mg/min

Injection: 10 mg/mL solution in 10 mL (100 mg) and 50 mL (500 mg) single-dose vials

None listed.

• Hemorrhage: Severe and sometimes fatal hemorrhagic events reported. Permanently discontinue for Grade 3 or 4 bleeding.
• Gastrointestinal Perforation: Permanently discontinue if GI perforation occurs.
• Impaired Wound Healing: Withhold prior to scheduled surgery. Do not administer for at least 2 weeks after major surgery and until adequate wound healing.
• Arterial Thromboembolic Events: Permanently discontinue for severe ATE.
• Hypertension: Monitor and manage with antihypertensives. Temporarily suspend for severe hypertension; permanently discontinue for hypertensive crisis.
• Infusion-Related Reactions: Pre-medicate with IV histamine H1 antagonist. For Grade 1-2, reduce rate by 50%; for Grade 3-4, permanently discontinue.
• Proteinuria: Monitor with urine dipstick and/or urinary protein-creatinine ratio.
• Embryo-Fetal Toxicity

Hypertension (26%), diarrhea (14%), headache (9%), hyponatremia (6%), proteinuria (3-17% depending on indication), epistaxis (12%)

Arterial thromboembolic events (1.7%), GI perforation (1.2%), severe hemorrhage (3.4%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

No formal drug interaction studies conducted.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Ramucirumab is a human IgG1 monoclonal antibody that specifically binds to VEGF Receptor 2 (VEGFR2), blocking the binding of VEGF-A, VEGF-C, and VEGF-D ligands. This inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation and migration of human endothelial cells and reducing tumor vascularity and growth.

Half-life: approximately 14 days. Clearance: 0.015 L/h. Steady-state reached by approximately the 6th dose with every-2-week dosing.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• REGARD — Ramucirumab vs. placebo in advanced gastric/GEJ adenocarcinoma after 1L chemo. Phase III, n=355.
  🔬 NCT00917384 ↗ 📄 Primary Publication ↗
• REVEL — Ramucirumab + docetaxel vs. placebo + docetaxel in 2L advanced NSCLC. Phase III, n=1253.
  🔬 NCT01168973 ↗ 📄 Primary Publication ↗

Cyramza has FDA-approved indications across the following cancer types covered on PipelineEvidence: