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Summary Safety Review – Galexos (simeprevir)

Summary Safety Review - Galexos (simeprevir)January 27, 2016 – Health Canada – Summary Safety Review – GALEXOS (simeprevir) – Assessing the Potential Risk of Severe Liver Problems


Galexos (simeprevir)

Potential Safety Issue

Severe liver problems

Key Messages

  • Galexos (simeprevir) is a drug used to treat chronic hepatitis C.
  • A safety review was carried out by Health Canada after Japan published a risk communication on severe liver problems and related death with simeprevir use.
  • The prescribing information for Galexos has been updated with warnings about the risk of severe liver problems and related death. It also reminds healthcare professionals to frequently monitor patients for liver problems when using this drug.


Health Canada carried out a safety review after Japan published a risk communication on severe liver problems and related death with the use of simeprevir. In patients with liver damage due to advanced chronic hepatitis C, increased levels of bilirubin in the blood can be a sign that the liver is not functioning properly. The use of simeprevir can further increase bilirubin levels in the blood; this risk is already included in the prescribing information.

Use in Canada

  • Simeprevir has been marketed in Canada under the brand name of Galexos since 2013.
  • Simeprevir is a drug used for the treatment of chronic hepatitis C. It is taken as an oral tablet for 12 weeks in combination with other medicinal products such as peginterferon alfa and ribavirin or with sofosbuvir.
  • Recently, the number of prescriptions in Canada for simeprevir has gone from 1700 prescriptions between July and September 2014, to 16 prescriptions between July and September 2015.

Safety Review Findings

  • At the time of the review, Health Canada had received 11 Canadian reports of severe liver problems, including 2 deaths, suspected of being linked with simeprevir. Upon review of these cases, no conclusions could be made regarding what role, if any, the drug may have played, due to limited information from these cases.
  • In Japan, 8 cases of severe blood bilirubin levels and 3 deaths had been reported in association with simeprevir. Ethnic differences in susceptibility to liver problems exist, therefore the information from these cases needs to be interpreted with caution when considering the risk of simeprevir for other populations.
  • Information was also received from the manufacturer about cases of severely abnormal bilirubin levels suspected of being linked with simeprevir. In some of these cases, the contribution of simeprivir to the side effect could not be ruled out.

Conclusions and Actions

  • Based on all the information reviewed, Health Canada concluded that the prescribing information should be updated to reflect the level of evidence related to the risk of severe liver problems.
  • The manufacturer of Galexos (simeprevir) has updated the prescribing information to:
    • Warn about the risk of severe liver problems and related death,
    • Advise healthcare professionals to do blood tests to check for liver function before and during treatment, and
    • Not use Galexos (simeprevir) in patients who have moderate or severe liver damage.
  • Health Canada will publish a labelling update notice in the January 2016 issue of the Health Product InfoWatch to raise awareness of the labelling update for simeprevir.
  • Health Canada will continue to monitor side effect information involving simeprevir, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate or contact the manufacturer, Janssen Inc., at 1-800-567-3331 or 1-800-387-8781.