DEFIBROTIDE Drug Interactions: What You Need to Know

INTERACTIONS Antithrombotic Agents DEFITELIO may enhance the pharmacodynamic activity of antithrombotic/fibrinolytic drugs such as heparin or alteplase. Concomitant use of DEFITELIO with antithrombotic or fibrinolytic drugs is contraindicated because of an increased risk of hemorrhage [see Contraindications (4) ] .

• DEFITELIO may enhance the activity of antithrombotic/fibrinolytic drugs. ( 7 )

The use of DEFITELIO is contraindicated in the following conditions:

• Concomitant administration with systemic anticoagulant or fibrinolytic therapy [see Warnings and Precautions (5.1) ]
• Known hypersensitivity to DEFITELIO or to any of its excipients [see Warnings and Precautions (5.2) ]
• Concomitant administration with systemic anticoagulant or fibrinolytic therapy. ( 4 )
• Known hypersensitivity to DEFITELIO or to any of its excipients. ( 4 )

AND PRECAUTIONS

• Hemorrhage: Monitor patients for bleeding. Withhold or discontinue DEFITELIO if significant bleeding occurs. ( 2.3 , 5.1 )
• Hypersensitivity Reactions: If severe or life threatening allergic reaction occurs, discontinue DEFITELIO, treat according to standard of care, and monitor until signs and symptoms resolve. ( 2.3 , 5.2 )

5.1 Hemorrhage DEFITELIO increased the activity of fibrinolytic enzymes in vitro, and it may increase the risk of bleeding in patients with VOD after hematopoietic stem-cell transplantation (HSCT). Do not initiate DEFITELIO in patients with active bleeding. Monitor patients for signs of bleeding. If patients on DEFITELIO develop bleeding, discontinue DEFITELIO, treat the underlying cause, and provide supportive care until the bleeding has stopped <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) ]</span> . Concomitant use of DEFITELIO and a systemic anticoagulant or fibrinolytic therapy (not including use for routine maintenance or reopening of central venous lines) may increase the risk of bleeding. Discontinue anticoagulants and fibrinolytic agents prior to DEFITELIO treatment, and consider delaying the start of DEFITELIO administration until the effects of the anticoagulant have abated <span class="opacity-50 text-xs">[see Contraindications (4) ]</span> .

5.2 Hypersensitivity Reactions Hypersensitivity reactions have occurred in less than 2% of patients treated with DEFITELIO. These reactions include rash, urticaria and angioedema. One case of an anaphylactic reaction was reported in a patient who had previously received DEFITELIO. Monitor patients for hypersensitivity reactions, especially if there is a history of previous exposure. If a severe hypersensitivity reaction occurs, discontinue DEFITELIO, treat according to the standard of care, and monitor until symptoms resolve <span class="opacity-50 text-xs">[see Dosage and Administration (2.3) ]</span> .