Administration of Immune Checkpoint Inhibitors to Patients on Warfarin May Elevate PT-INR

Yakugaku Zasshi. 2025;145(1):71-78. doi: 10.1248/yakushi.24-00087.

Abstract

The relationship between the concomitant use of immune checkpoint inhibitors (ICIs) and elevated prothrombin time-to-international standard ratio (PT-INR) in patients receiving warfarin remains unclear. In the present study, 26 patients treated with ICIs during warfarin therapy were examined for increases in PT-INR within 60 d of ICI administration. Of these patients, 13 developed Grade 2 or higher PT-INR elevations, 5 of which required the immediate administration of vitamin K. The increased risk of bleeding and the impact on the continuation of cancer drug therapy are significant burdens for patients. Immune-related adverse events caused by ICIs have been suggested as one of the reasons for increases in PT-INR, and patients taking warfarin and ICIs need to be managed in consideration of the risk of elevated PT-INR by frequently checking the blood coagulation capacity.

Keywords: drug interaction; immune checkpoint inhibitor; warfarin.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anticoagulants / administration & dosage
  • Anticoagulants / adverse effects
  • Drug Interactions
  • Female
  • Hemorrhage* / chemically induced
  • Humans
  • Immune Checkpoint Inhibitors* / adverse effects
  • International Normalized Ratio*
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Prothrombin Time*
  • Risk
  • Vitamin K / antagonists & inhibitors
  • Warfarin* / administration & dosage
  • Warfarin* / adverse effects

Substances

  • Warfarin
  • Immune Checkpoint Inhibitors
  • Anticoagulants
  • Vitamin K