From the Guidelines
Impaired renal function is not an absolute contraindication for Libtayo (cemiplimab), but patients should be closely monitored for immune-related renal toxicity. According to the American Society of Clinical Oncology clinical practice guideline 1, checkpoint inhibitor therapy, including cemiplimab, appears to be safe in patients with baseline renal impairment from a nonimmune basis. However, patients with a renal allograft are at high risk of rejecting the transplanted kidney and requiring dialysis.
Key Considerations
- Patients should have their renal function (serum creatinine) checked prior to every dose of checkpoint inhibitor therapy 1.
- For those with new elevations in creatinine, therapy should be held while other potential causes are evaluated and treated appropriately 1.
- If immune-related renal toxicity is suspected, patients should be treated empirically according to the algorithm 1.
- Regular monitoring of renal function throughout treatment is recommended to detect any deterioration early.
Monitoring and Management
- The incidence of grade 3 or 4 acute kidney injury (AKI) was < 1% with single agents and 1.6% with the combination of nivolumab plus ipilimumab 1.
- Emerging data suggest a higher incidence rate of AKI (range, 9.9% to 29%) with immune checkpoint inhibitors, with the vast majority being stage I based on AKI network criteria and typically involving electrolyte disturbances rather than declines in renal function 1.
- In cases of immune-mediated nephritis, cemiplimab may need to be temporarily withheld or permanently discontinued depending on the severity, and corticosteroids may be required 1.
From the Research
Impaired Renal Function and Libtayo (Cemiplimab)
- There is no direct evidence in the provided studies that specifically addresses whether impaired renal function is a contraindication for Libtayo (cemiplimab) 2, 3, 4, 5, 6.
- However, the studies suggest that impaired renal function can affect the pharmacokinetics and pharmacodynamics of various drugs, including anticancer agents 3, 4, 6.
- Some drugs, such as cisplatin, etoposide, and ifosfamide, require dose adjustment or are contraindicated in patients with impaired renal function 3, 4.
- The use of serum creatinine as a screening test for impaired renal function may not always be reliable, and estimated glomerular filtration rate (eGFR) may be a more accurate measure 5.
- Immune checkpoint inhibitors, such as Libtayo (cemiplimab), can cause kidney injury, including acute interstitial nephritis, which may require treatment with steroids 6.
Renal Function and Drug Therapy
- Patients with impaired renal function may require dose adjustments or alternative treatments for various medications, including anticancer agents 3, 4, 6.
- The pharmacokinetics and pharmacodynamics of drugs can be altered in patients with impaired renal function, and careful monitoring and dose adjustment may be necessary 3, 4, 6.
- The use of diuretics, magnesium supplementation, and adequate hydration may be necessary to avoid renal impairment in patients receiving certain anticancer agents, such as cisplatin 6.