RAMUCIRUMAB INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Non-healing wound or fracture
- Major surgery within prior 28 days
- Chronic anti-platelet therapy, NSAIDs (including aspirin > 325mg/day)
- Therapeutic anticoagulation, unless on stabilized outpatient doses
- Uncontrolled CNS metastases
- Pre-existing bleeding diathesis or coagulopathy
- History of GI perforation and/or fistulae within prior 6 months
- History of gross hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) within 2 months of therapy initiation
- Patients with tumor involving major blood vessels or intratumor cavitation
- Uncontrolled hypertension
- Severe renal impairment defined as CrCl < 15 ml/min
- Pre-existing proteinuria (> 2 g urine protein/24 hrs)
- Severe hepatic impairment defined as bilirubin > 3x Upper Limit of Normal
- Pregnancy
- Breastfeeding
Inclusion Criteria (Indications)
- Diagnosis of advanced or metastatic gastric or gastro-esophageal Junction (GEJ) adenocarcinoma WITH disease progression on prior fluoropyrimidine- or platinum-containing chemotherapy
- Diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with docetaxel in patients WITH disease progression on prior platinum-based chemotherapy; Patients with EGFR+ or ALK+ disease should have progressed on FDA-approved therapies for those aberrations
- Diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) in combination with erlotinib for first-line treatment in patients whose tumors have an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation
- Diagnosis of metastatic colorectal cancer in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) WITH disease progression on prior first-line therapy with bevacizumab, oxaliplatin and a fluoropyrimidine
- Diagnosis of hepatocellular carcinoma Barcelona Clinic Liver Cancer (BCLC) Stage C or B disease refractory or not amendable to locoregional therapy, Child-Pugh Class A and an alpha fetoprotein (AFP) > 400 ng/mL who have been previously treated with sorafenib
Additional Inclusion Criteria
- Care for the condition provided by VA or VA Community Care oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 – 1
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 3 months after last dose