Be alert for the possible signs of renal or pulmonary dysfunction

RENAL DYSFUNCTION MAY INCLUDE1-3
Possible signs of renal dysfunction
Decreased urinary output
Elevated creatinine levels
Decreased creatinine clearance
Decreased glomerular filtration rate
A need for dialysis
PULMONARY DYSFUNCTION MAY INCLUDE2-5
Possible signs of pulmonary dysfunction
Reduced oxygen saturation
– Increased respiratory rate
– Shortness of breath/dyspnea
Need for supplemental oxygen support (nasal cannula)
Pulmonary infiltrates
Pleural effusion
Ventilator dependence

Learn more how Defitelio is thought to act across the VOD cascade

See the progressive cascade of VOD

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.

References:
  1. Ng CK, Chan MH, Tai MH, et al. Hepatorenal syndrome. Clin Biochem Rev. 2007;28(1):11-17.
  2. Richardson PG, Murakami C, Jin Z, et al. Multi-institutional use of defibrotide in 88 patients after stem cell transplantation with severe veno-occlusive disease and multisystem organ failure: response without significant toxicity in a high-risk population and factors predictive of outcome. Blood. 2002;100(13):4337-4343.
  3. Richardson PG, Riches ML, Kernan NA, et al. Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure. Blood. 2016;127(13):1656-1665.
  4. McDonald GB, Hinds MS, Fisher LD, et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118(4):255-267.
  5. Cooke KR. Hepatic veno-occlusive disease: the importance of early detection. Clin Adv Hematol Oncol. 2015;13(12)(suppl 12):1-6.