Ramucirumab

CYRAMZA ® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: as a single agent or in combination with paclitaxel, for treatment of adults with advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. in combination with erlotinib, for first-line treatment of adults with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. in combination with docetaxel, for treatment of adults with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.

Ramucirumab is a VEGFR2 antagonist that specifically binds VEGFR2 and blocks binding of VEGFR ligands, VEGF-A, VEGF-C, and VEGF-D. As a result, ramucirumab inhibits ligand-stimulated activation of VEGFR2, thereby inhibiting ligand-induced proliferation, and migration of human endothelial cells. Ramucirumab inhibited angiogenesis in an in vivo animal model.

For intravenous infusion only. Do not administer as an intravenous push or bolus. Premedicate before each infusion. Gastric Cancer: Administer CYRAMZA 8 mg/kg every 2 weeks as a single agent or in combination with weekly paclitaxel. Non-Small Cell Lung Cancer: Administer CYRAMZA 10 mg/kg every 2 weeks with daily erlotinib. Administer CYRAMZA 10 mg/kg on Day 1 of a 21-day cycle prior to docetaxel. Colorectal Cancer: Administer CYRAMZA 8 mg/kg every 2 weeks prior to FOLFIRI. Hepatocellular Carcinoma: Administer CYRAMZA 8 mg/kg every 2 weeks.

None None

Hemorrhage: CYRAMZA increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue CYRAMZA in patients who experience severe bleeding. Gastrointestinal Perforations: CYRAMZA increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue CYRAMZA in patients who experience a gastrointestinal perforation. Impaired Wound Healing: Withhold CYRAMZA for 28 days prior to elective surgery. Do not administer CYRAMZA for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of CYRAMZA after resolution of wound healing complications has not been established. Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with CYRAMZA. Permanently discontinue CYRAMZA in patients who experience an ATE.

The following serious adverse reactions are described elsewhere in the labeling: Hemorrhage. Gastrointestinal Perforations. Impaired Wound Healing. Arterial Thromboembolic Events. Hypertension. Infusion-Related Reactions. Worsening of Pre-existing Hepatic Impairment. Posterior Reversible Encephalopathy Syndrome. Proteinuria Including Nephrotic Syndrome. Thyroid Dysfunction. The most common adverse reactions observed in single agent CYRAMZA-treated gastric cancer patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. The most common adverse reactions observed in patients treated with CYRAMZA with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis.

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze or shake the vial.