Ofev® (nintedanib): Information on Severe Liver Injury and the Need for Regular Monitoring of Liver Function Associated with the Use in Patients with Idiopathic Pulmonary Fibrosis (IPF)

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Date: 5 January 2018

 

Description:

Cases of drug-induced liver injury (DILI) in patients treated with Ofev® have been reported worldwide in the post-marketing period, including a case of severe liver injury associated with a fatal outcome.

Healthcare professionals are advised to monitor transaminases and bilirubin levels:

  • just before starting treatment;
  • at regular intervals during the first three months of treatment; and
  • periodically thereafter (e.g. at each patient visit) or as clinically indicated.

Dose reduction or treatment interruption is recommended for managing transaminase elevations according to the current product information.

Please refer to the Direct Healthcare Professional Communication (DHPC) letter issued by Boehringer Ingelheim (Malaysia) Sdn. Bhd. in agreement with NPRA for further information.

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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