Tag Archives: Galexos

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

Product

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.

Overview

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.

PharmaCare Covered Hep C Treatments

PharmaCare Covered Hep C TreatmentsThe number of BC PharmaCare covered hep C treatments has been increasing and so has the information gathered by the Hepatitis C Treatment Information Project. The Hep C TIP now has new pages dedicated to BC’s PharmaCare and the treatments that are covered by it. These pages are:

Treatments Targeted Genotype
Ribavirin 1 – 3
Pegylated Interferon with Ribavirin (Pegasys RBV) 2 – 6
Victrelis (boceprevir) 1
Galexos (simeprevir) 1
Sovaldi (sofosbuvir) 1 – 3
Harvoni (ledipasvir and sofosbuvir) 1

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

Galexos Sovaldi Combination Earns Notice of Compliance

Galexos Sovaldi pictureThe combination of Janssen’s Galexos (simeprevir) and Gilead’s Sovaldi (sofosbuvir), for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, has received  a notice of compliance.

the news

Receiving a notice of compliance allows the treatment to be sold in Canada with official approval. If a drug has a notice of compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. At this stage private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).

Janssen’s Galexos has also been issued non-conditional approval for use in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.

PharmaCare Approves Simeprevir PegIFN/RBV Combination

sq_checkJanssen Inc.’s simeprevir, brand name Galexos, in combination with peginterferon/ribavirin was V110 just approved by BC’s PharmaCare for the treatment of chronic hepatitis C genotype 1 in patients with or without Notice compensated cirrhosis and who have:

  • never tried to treat their wholesale nfl jerseys hepatitis C
    OR
  • tried treatment but the virus came back
    OR
  • tried treatment but weren’t cured

AND

Who Post have ALL of the following:

  • Lab-confirmed hepatitis C genotype 1
  • A prescription for the treatment from a qualified healthcare provider
  • Detectable levels of hep C in the last 6 months
  • Recent lab-confirmation of NS3 Q80K polymorphism negative for patients with hep C genotype 1a cheap jerseys subtype or genotype 1 with indeterminate subtype. Retesting is required is for all those who had their genotype tested before May 1, 2012.
  • A liver fibrosis stage F2 or greater

BUT

Who have NOT been or ARE NOT being cheap nfl jerseys treated with a LEDIPASVIR/SOFOSBUVIR protease inhibitor.

Please ask your wholesale jerseys healthcare provider for more information about simeprevir (Galexos) in combination with peginterferon/ribavirin (PegIFN/RBV) and about other hep C cheap mlb jerseys treatments.

For more Survey information about currently Bro approved hep C treatments in BC, emerging treatments, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.