From the FDA Drug Label
CONTRAINDICATIONS Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Nintedanib is contraindicated in patients with significant impairment of renal function, including those with CKD and a creatinine clearance under 60 mL per minute.
- The drug carries an increased risk of toxicity due to impaired excretion in patients with renal impairment. 1
From the Research
Nintedanib should be used with caution in patients with chronic kidney disease (CKD), though no specific dose adjustments are required for mild to moderate CKD (eGFR 30-89 mL/min/1.73m²). For patients with severe CKD (eGFR <30 mL/min/1.73m²), limited data exists and careful monitoring is essential 2. The standard dose of nintedanib is 150 mg twice daily, which can be reduced to 100 mg twice daily if tolerability issues arise. When treating CKD patients with nintedanib, regular monitoring of kidney function is recommended, with assessments at baseline and periodically throughout treatment. Nintedanib is primarily metabolized by the liver with minimal renal excretion (less than 1%), which explains why dose adjustments aren't typically needed for kidney impairment 2. However, patients with CKD often have multiple comorbidities and take various medications, increasing the risk of drug interactions. Common side effects include diarrhea, nausea, and elevated liver enzymes, which may be managed with dose reductions or temporary interruptions. Adequate hydration should be maintained, especially in CKD patients who may have compromised fluid balance. If significant deterioration in kidney function occurs during treatment, consider temporarily interrupting or discontinuing nintedanib therapy after evaluating the risk-benefit ratio for the individual patient. Some studies suggest that nintedanib may have anti-fibrotic effects in the kidney, which could be beneficial for patients with CKD 3. However, the risk of renal thrombotic microangiopathy (TMA) should also be considered, as reported in a case study where nintedanib-induced renal TMA was reversible and possibly dose-dependent 4. Overall, the use of nintedanib in patients with CKD requires careful consideration of the potential benefits and risks, as well as close monitoring of kidney function and other potential side effects. Key considerations for using nintedanib in CKD patients include:
- Regular monitoring of kidney function
- Management of common side effects such as diarrhea, nausea, and elevated liver enzymes
- Maintenance of adequate hydration
- Evaluation of the risk-benefit ratio for individual patients
- Consideration of potential anti-fibrotic effects in the kidney
- Awareness of the risk of renal thrombotic microangiopathy (TMA) 4, 2, 3.