Safety Profile

ADVERSE REACTIONS INDEPENDENT OF CAUSALITY ≥10% ANY GRADE OR GRADE 4–5 ≥2% OF DEFITELIO-TREATED PATIENTS1
Adverse reactiona Defitelio (n=176)
n (%)
Any grade Grade 4–5b
Hypotension 65 (37) 12 (7)
Diarrhea 43 (24) 0
Vomiting 31 (18) 0
Nausea 28 (16) 0
Epistaxis 24 (14) 0
Pulmonary alveolar hemorrhage 15 (9) 12 (7)
Gastrointestinal hemorrhage 15 (9) 5 (3)
Sepsis 12 (7) 9 (5)
Graft-vs-host disease 11 (6) 7 (4)
Lung infiltration 10 (6) 5 (3)
Pneumonia 9 (5) 5 (3)
Pulmonary hemorrhage 7 (4) 4 (2)
Infection 6 (3) 4 (2)
Hemorrhage intracranial 5 (3) 4 (2)
Hyperuricemia 4 (2) 4 (2)
Cerebral hemorrhagec 3 (2) 3 (2)

aExcludes events considered to be due to the underlying disease: multi-organ failure, veno-occlusive disease, respiratory failure, renal failure, and hypoxia.

bAdverse reactions considered life-threatening or fatal.

cCerebral hemorrhage has been included in the table due to clinical relevance.

Learn more about the proposed mechanism of action of Defitelio

Dosing and administration information for Defitelio

HSCT=hematopoietic stem-cell transplantation; VOD=veno-occlusive disease.

Indication

Defitelio® (defibrotide sodium) is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

Important Safety Information

Contraindications

Defitelio is contraindicated in the following conditions:
  • Concomitant administration with systemic anticoagulant or fibrinolytic therapy
  • Known hypersensitivity to Defitelio or to any of its excipients

Warnings and Precautions

Hemorrhage

Defitelio may increase the risk of bleeding in patients with VOD after HSCT. Do not initiate Defitelio in patients with active bleeding. Monitor patients on Defitelio for signs of bleeding. If bleeding occurs, withhold or discontinue Defitelio.

Concomitant systemic anticoagulant or fibrinolytic therapy may increase the risk of bleeding and should be discontinued prior to Defitelio treatment. Consider delaying Defitelio administration until the effects of the anticoagulant have abated.

Hypersensitivity Reactions

Hypersensitivity reactions including rash, urticaria, and angioedema have occurred in less than 2% of patients treated with Defitelio. 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.

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥10% and independent of causality) with Defitelio treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis.

Please see full Prescribing Information.

Reference:
  1. Defitelio [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.