Laboratory Testing Recommendations for Nintedanib Therapy

Initial Laboratory Tests Before Starting Ofev

The American College of Rheumatology recommends complete blood count (CBC) to establish baseline hematologic parameters in patients starting nintedanib therapy, a medication with potential hepatotoxicity and bleeding risks 1, 2
Comprehensive metabolic panel including liver function tests (ALT, AST, alkaline phosphatase, bilirubin) should be performed to screen for pre-existing liver disease in patients initiating nintedanib, as recommended by the American Association for the Study of Liver Diseases 1, 3
Renal function tests (BUN, creatinine, eGFR) should be assessed to evaluate kidney function in patients starting nintedanib, according to the American Heart Association 1, 2
Electrolytes (sodium, potassium, calcium, magnesium) should be monitored in patients initiating nintedanib therapy, as suggested by the American College of Cardiology 2
Coagulation studies (INR) should be performed to assess bleeding risk in patients starting nintedanib, a medication that may increase bleeding risk, as recommended by the American College of Rheumatology 1
Pregnancy test should be performed for women of childbearing potential before starting nintedanib therapy, as recommended by the American College of Obstetricians and Gynecologists 1

Liver function tests (ALT, AST, bilirubin) should be monitored every month for the first 3 months after starting nintedanib therapy, due to the high risk of hepatotoxicity, as recommended by the American Association for the Study of Liver Diseases 1
Patients on nintedanib should be monitored for diarrhea and weight loss at each visit during the first 3 months of therapy, as suggested by the American Gastroenterological Association 1
Blood pressure should be monitored due to potential cardiovascular effects of nintedanib, as recommended by the American Heart Association 1
After 3 months, liver function tests should be performed every 3 months, and patients should continue to be monitored for gastrointestinal symptoms, weight loss, and cardiovascular adverse events, as recommended by the American College of Cardiology 1

For liver enzyme elevations, the American Association for the Study of Liver Diseases recommends discontinuing nintedanib treatment if AST or ALT >3× ULN with signs of liver injury, and interrupting treatment until values return to baseline if AST or ALT >3× to <5× ULN without signs of liver injury 1
The American College of Rheumatology recommends that failure to obtain baseline liver function tests may lead to difficulty interpreting subsequent abnormalities, and inadequate monitoring during the first 3 months when risk of hepatotoxicity is highest 1