Ramucirumab

DEA Class; Rx

Common Brand Names; Cyramza

• Antineoplastics, VEGF Inhibitor

Non-Small Cell Lung Cancer

Combination therapy with docetaxel

• Indicated in combination with docetaxel for metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy

Combination therapy with erlotinib

• Indicated in combination with erlotinib, for first-line treatment of metastatic NSCLC in patients whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations

As a single agent or in combination with paclitaxel for advanced gastric or gastro-esophageal junction adenocarcinoma in patients with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy

Indicated for use in combination with FOLFIRI for patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first-line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen

Indicated as a single agent for hepatocellular carcinoma (HCC) in patients with alpha fetoprotein (AFP) of ≥400 ng/mL who have been treated with sorafenib

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Single agent

• Hypertension (16%)

• Diarrhea (14%)

Combination therapy

• Fatigue/asthenia (57%)

• Neutropenia (54%)

• Neutropenia, Grade 3-4 (41%)

• Diarrhea (32%)

• Epistaxis (31%)

• Peripheral edema (25%)

• Hypertension (25%)

• Stomatitis (20%)

• Proteinuria (17%)

• Hypertension, Grade 3-4 (15%)

• Thrombocytopenia (13%)

• Fatigue/asthenia, Grade 3-4 (12%)

• Hypoalbuminemia (11%)

Combination with erlotinib

• Infections (81%)

• ALT increased (74%)

• AST increased (71%)

• Diarrhea (70%)

• Hypertension (45%)

• Anemia (42%)

• Stomatitis (42%)

• Thrombocytopenia (41%)

• Proteinuria (34%)

• Alopecia (34%)

• Epistaxis (34%)

• Neutropenia (33%)

• Alkaline phosphatase increased (25%)

• Hypokalemia (24%)

• Hypertension, Grade 3-4 (24%)

• Peripheral edema (23%)

• Infections, Grade 3-4 (17%)

• Headache (15%)

• ALT increased, Grade 3-4 (11%)

Increased risk of hemorrhage and GI hemorrhage, including severe and sometimes fatal hemorrhagic events; permanently discontinue in patients who experience severe bleeding

Serious, sometimes fatal, arterial thromboembolic events including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia reported during clinical trials

Increased incidence of severe hypertension reported; control hypertension before initiating treatment and monitor blood pressure q2weeks or more frequently as indicated; temporarily suspend therapy for severe hypertension

Infusion-related reactions observed that include rigors/tremors, back pain/spasms, chest pain and/or tightness, chills, flushing, dyspnea, wheezing, hypoxia, and paresthesia; in severe cases, symptoms included bronchospasm, supraventricular tachycardia, and hypotension

Ramucirumab is an antiangiogenic therapy that can increase the risk of GI perforation and affect wound healing; withhold prior to surgery; permanently discontinue ramucirumab in patients who experience a gastrointestinal perforation

Impaired wound healing can occur with antibodies inhibiting the VEGF or VEGFR pathway; VEGFR2 antagonist has the potential to adversely affect wound healing; not studied in patients with serious or non-healing wounds

Withhold for 28 days prior to elective surgery; do not administer for at least 2 weeks following a major surgical procedure and until adequate wound healing; safety of resumption after resolution of wound healing complications not established

Clinical deterioration, manifested by new-onset or worsening encephalopathy, ascites, or hepatorenal syndrome, reported in patients with Child-Pugh B or C cirrhosis; use only if the benefits outweigh the risks

Posterior reversible encephalopathy syndrome (PRES), also known as reversible posterior leukoencephalopathy syndrome (RPLS), reported; confirm diagnosis with magnetic resonance imaging; permanently discontinue in patients who develop PRES; symptoms may resolve or improve within days; some patients can experience ongoing neurologic sequelae or death

Based on its mechanism of action, fetal harm may occur when administered to a pregnant woman

There are no available data on use in pregnant women

Unknown if distributed in human breast milk; a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother

Ramucirumab 

IV solution

• 10mg/mL (10mL and 50mL vials)