Adult Dosing

Gastric Cancer

• 8 mg/kg every 2 weeks IV over 60 mins. Continue ramucirumab until disease progression or unacceptable toxicity
• Do not administer ramucirumab as an intravenous push or bolus

Note:

• Premedicate all patients with an intravenous histamine H1 antagonist before ramucirumab infusion
• For patients who have experienced a Grade 1 or 2 infusion reaction, also premedicate with dexamethasone (or equivalent) and acetaminophen prior to each ramucirumab infusion
• Refer package insert for dose modifications, preparation for administration procedure

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy

• Hypersensitivity to any of the ingredients of the product

• Increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events have been reported with ramucirumab. Permanently discontinue ramucirumab in patients who experience severe bleeding

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatc iimpairment: Dose adjustments not defined

• Increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events have been reported with ramucirumab. Permanently discontinue ramucirumab in patients who experience severe bleeding (US Black Box Warning)
• Serious, sometimes fatal, arterial thromboembolic events (ATEs) including myocardial infarction, cardiac arrest, cerebrovascular accident, and cerebral ischemia have been reported with ramucirumab. Permanently discontinue ramucirumab in patients who experience a severe ATE
• Severe hypertension occurred in patients receiving ramucirumab. Control hypertension before initiating ramucirumab. Closely monitor blood pressure every two weeks or more frequently as indicated during treatment. Discontinue the treatment if hypertension cannot be controlled with antihypertensives or in patients with hypertensive crisis or hypertensive encephalopathy
• Infusion related reactions (IRRs) may occur with therapy. Monitor patients during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment. Immediately and permanently discontinue therapy for Grade 3 or 4 IRRs
• Increased the risk of gastrointestinal perforation has been reported with therapy. Permanently discontinue ramucirumab in patients who experience a gastrointestinal perforation
• Ramucirumab is an antiangiogenic therapy with the potential to adversely affect wound healing. Withhold ramucirumab prior to surgery
• Clinical deterioration, manifested by new onset or worsening encephalopathy, ascites, or hepatorenal syndrome have been reported in patients with Child-Pugh B or C cirrhosis who received single-agent ramucirumab
• Rare events of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported with ramucirumab. Confirm the diagnosis of RPLS with MRI and discontinue ramucirumab in patients who develop RPLS

Pregnancy Category:B

Breastfeeding: As per manufacturer's data, it is unknown whether golimumab is excreted in breast milk. Manufacturer recommends discontinuation of nursing or discontinuation of therapy, taking into account the importance of the drug to the mother.

• CV: Hypertension, arterial thromboembolic events
• CNS: Headache
• NEURO: Reversible posterior leukoencephalopathy syndrome
• GI: Gastrointestinal perforation, diarrhea, intestinal obstruction
• GU: Proteinuria
• HEMA: Hemorrhage, neutropenia, epistaxis
• METABOLIC: Hyponatremia
• DERM: Rash
• HEPA: Cirrhosis
• LOCAL: Infusion related reactions

• Anti-neoplastic agent: vascular endothelial growth factor receptor 2 (VEGFR2) antagonist which inhibits ligand-stimulated activation of VEGFR2, thereby preventing proliferation, and migration of human endothelial cells.
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Cyramza

US Availability

Cyramza

• INJ: 100 mg/10 mL
• INJ: 500 mg/10 mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Endothelin Antagonists