Cyramza (Ramucirumab) Monitoring Requirements
Cyramza requires monitoring for proteinuria by urine dipstick and/or urinary protein creatinine ratio prior to and during administration, but a complete urinalysis (U.A.) is not specifically mandated as a routine pre-administration requirement. 1
Required Monitoring for Proteinuria
The FDA label explicitly requires proteinuria monitoring using either urine dipstick or urinary protein creatinine ratio. 1 This is distinct from a complete urinalysis, which includes microscopic examination and other parameters not specifically required for ramucirumab administration.
Specific Monitoring Protocol
- Monitor proteinuria by urine dipstick and/or urinary protein creatinine ratio before each dose of Cyramza 1
- If the urine dipstick result is 2+ or greater, perform a 24-hour urine collection for protein measurement 1
- Withhold Cyramza if urine protein levels are 2 or more grams over 24 hours 1
- Permanently discontinue Cyramza if urine protein levels exceed 3 grams over 24 hours or in the setting of nephrotic syndrome 1
Clinical Context
The incidence of proteinuria with Cyramza across six clinical studies in 2,137 patients ranged from 3-34% for all grades, with Grade ≥3 proteinuria (including 4 patients with nephrotic syndrome) ranging from <1-3%. 1
Important Distinction
Routine urinalysis with microscopic examination is not necessary for Cyramza administration, unlike the monitoring required for immune checkpoint inhibitors where routine urinalysis is not necessary except to rule out UTIs or evaluate suspected renal immune-related adverse events. 2 The specific requirement for Cyramza is focused proteinuria monitoring, not comprehensive urinalysis.