Esbriet® (pirfenidone): Drug-induced liver injury (DILI)

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Description

Esbriet® (pirfenidone) is an anti-fibrotic and anti-inflammatory agent indicated for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Elevations of liver enzymes are a known risk of Esbriet®. However, treatment with pirfenidone has recently been associated with drug-induced liver injury (DILI) in patients with IPF. Serious hepatic adverse events including isolated cases with fatal outcome have been reported in the post-marketing setting, possibly due to idiosyncratic reactions to pirfenidone. The frequency of clinically relevant DILI is estimated as rare (≥1/10,000 to <1/1,000).

Several measures should be considered in patients receiving Esbriet®, as follows:

  • As the majority of the reported hepatic events occurred within the first few months of treatment, it is advised that hepatic transaminase and bilirubin levels be investigated:
    • before treatment initiation;
    • at monthly intervals for the first 6 months of therapy;
    • then every 3 months throughout therapy.
  • Liver function should be promptly measured in patients with symptoms that suggest liver injury, such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. 

 

The prescribing information of Esbriet® will be updated to reflect the risk of clinically relevant DILI and recommendations on additional monitoring of liver function.

NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.

 

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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