Cyramza Injection

Ramucirumab ® 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. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Ramucirumab. in combination with FOLFIRI, for the treatment of adults with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. as a single agent, for the treatment of adults with hepatocellular carcinoma in patients who have an alpha fetoprotein of ≥400 ng/mL and have been treated with sorafenib. Gastric Cancer Ramucirumab ®, as a single agent or in combination with paclitaxel, is indicated for the treatment of adults with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Non-Small Cell Lung Cancer Ramucirumab, in combination with erlotinib, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Ramucirumab, in combination with docetaxel, is indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hemorrhage: Ramucirumab increases the risk of hemorrhage and gastrointestinal hemorrhage, including severe and fatal events. Permanently discontinue Ramucirumab in patients who experience severe bleeding. Gastrointestinal Perforations: Ramucirumab increases the risk of gastrointestinal perforation, which can be fatal. Permanently discontinue Ramucirumab in patients who experience a gastrointestinal perforation. Impaired Wound Healing: Withhold Ramucirumab for 28 days prior to elective surgery. Do not administer Ramucirumab for at least 2 weeks following a major surgical procedure and until adequate wound healing. The safety of resumption of Ramucirumab after resolution of wound healing complications has not been established. Arterial Thromboembolic Events (ATEs): Serious and sometimes fatal ATEs can occur with Ramucirumab. Permanently discontinue Ramucirumab in patients who experience an ATE. Hypertension: Monitor blood pressure and treat hypertension. Withhold Ramucirumab for severe hypertension. Permanently discontinue Ramucirumab for hypertension that cannot be controlled with antihypertensive therapy and for hypertensive crisis or hypertensive encephalopathy. Infusion-Related Reactions (IRR): Monitor for signs and symptoms during infusion. Reduce the infusion rate for Grade 1 or 2 IRR and permanently discontinue for Grade 3 or 4 IRR. Worsening of Pre-existing Hepatic Impairment: New onset or worsening encephalopathy, ascites or hepatorenal syndrome can occur in patients with Child-Pugh B or C cirrhosis. Posterior Reversible Encephalopathy Syndrome: Permanently discontinue Ramucirumab. Proteinuria Including Nephrotic Syndrome: Monitor for proteinuria. Withhold Ramucirumab for urine protein levels greater than or equal to 2 g per 24 hours. Permanently discontinue Ramucirumab for urine protein levels greater than 3 g per 24 hours or nephrotic syndrome. Thyroid Dysfunction: Monitor thyroid function during treatment. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Hemorrhage Ramucirumab increased the risk of hemorrhage and gastrointestinal hemorrhage, including Grade ≥3 hemorrhagic events. Across six clinical studies in 2137 patients with various cancers treated with Ramucirumab, the incidence of all Grade hemorrhage ranged from 13-55%. Grade 3-5 hemorrhage incidence ranged from 2-5%. Patients with gastric cancer receiving nonsteroidal anti-inflammatory drugs (NSAIDs) were excluded from enrollment in REGARD and RAINBOW; therefore, the risk of gastric hemorrhage in Ramucirumab-treated patients with gastric tumors receiving NSAIDs is unknown. Patients with NSCLC receiving therapeutic anticoagulation or with evidence of major airway invasion by cancer were excluded from REVEL. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

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 Ramucirumab-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 Ramucirumab with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. The most common adverse reactions observed in patients treated with Ramucirumab with erlotinib at a rate of ≥30% and ≥2% higher than placebo with erlotinib were, infections, hypertension, stomatitis, proteinuria, alopecia, and epistaxis. The most common laboratory abnormalities at a rate of ≥30% and ≥2% higher difference in incidence between arms were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia. The most common adverse reactions observed in patients treated with Ramucirumab with docetaxel at a rate of ≥30% and ≥2% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. The most common adverse reactions observed in patients treated with Ramucirumab with FOLFIRI at a rate of ≥30% and ≥2% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis. The most common adverse reactions observed in single agent Ramucirumab-treated HCC patients at a rate of ≥15% and ≥2% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities at a rate of ≥30% and a ≥2% higher difference in incidence between arms were thrombocytopenia, hypoalbuminemia, and hyponatremia. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the Warnings and Precautions section reflect exposure to Ramucirumab in 2137 patients from six studies: REGARD, RAINBOW, RAISE, REVEL, REACH-2, and RELAY. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.