Summary Safety Review - SOLIRIS (eculizumab) and BEXSERO - Assessing the Potential Risk of Hemolysis and Low Hemoglobin in Patients Treated with Soliris and Vaccinated with Bexsero

September 16, 2016

Product

Soliris (eculizumab)
Bexsero (Multicomponent Meningococcal B Vaccine [recombinant, adsorbed])

Potential Safety Issue

Increased risk of hemolysis and low hemoglobin when patients receiving Soliris were vaccinated with Bexsero

Key Messages

  • Soliris is a prescription drug used to treat patients with Paroxysmal Nocturnal Hemoglobinuria (PNH), or atypical Haemolytic Uremic Syndrome (aHUS). Patients receiving Soliris are at increased risk of meningitis (an inflammation of the lining of the brain) and should be vaccinated for meningitis before, or when, they start treatment with Soliris.
  • Bexsero is a vaccine used to protect against Neisseria meningitidis serogroup B, a germ (bacterium) that causes meningitis. Bexsero has been marketed in Canada since 2014, which is 5 years after Soliris began to be sold.
  • A Health Canada safety review of patients treated with Soliris concluded that there was an increased risk of anemia or the destruction of red blood cells (hemolysis) when patients already receiving Soliris were vaccinated with Bexsero. The risk was highest when patients already being treated with Soliris received a dose of Soliris within 2 weeks after being vaccinated with Bexsero.
  • The manufacturer has updated the Canadian product information for Soliris to include the risk of hemolysis with vaccines against Neisseria meningitidis serogroup B. To minimize the risk of hemolysis, the manufacturer recommends that patients who are already being treated with Soliris should only be vaccinated when their disease is controlled and the Soliris concentration in the blood is high.

Overview

The safety of all vaccines, including Bexsero, is under continuous monitoring by Health Canada and the Public Health Agency of Canada. Health Canada carried out a safety review of Bexsero after 1 year on the market. By studying cases reported to the Canada Vigilance program, more reports of serious side effects were found in patients that were also treated with Soliris than in other patients. Health Canada conducted a follow up review of Soliris to find out why there were more reports.

Use in Canada

  • Soliris is a prescription drug that is used to treat patients with a rare disease called Paroxysmal Nocturnal Hemoglobinuria (PNH), in which the immune system breaks down the patient's red blood cells (hemolysis). Soliris is also used to treat patients with a rare disease called atypical Haemolytic Uremic Syndrome (aHUS), in which activation of the immune system causes blood clots (thrombi) in small blood vessels throughout the body and kidney failure.
  • Soliris blocks part of the immune system called terminal complement in these patients, which makes them more likely to get life-threatening, sometimes deadly infections, including meningitis. The manufacturer recommends that patients taking Soliris should be vaccinated for meningitis before, or when they start treatment with Soliris. Patients vaccinated less than 2 weeks prior to starting Soliris therapy must receive antibiotics until 2 weeks after vaccination.
  • Soliris has been marketed in Canada since May 2009, and at that time, there was no vaccine against the Neisseria meningitidis group B bacteria available.
  • Bexsero is a vaccine used for the prevention of disease caused by the Neisseria meningitidis group B bacteria (germs). These germs can cause serious, and sometimes life threatening, infections of the lining of the brain and spine (meningitis) and blood poisoning (sepsis).
  • Bexsero has been marketed in Canada since February 2014, and is authorized for use in children aged 2 months to 17 years.

Safety Review Findings

  • Health Canada's safety review of Bexsero found that low hemoglobin was a common side effect in patients treated with Soliris, but not in other patients vaccinated with Bexsero.
  • A review of reports of low hemoglobin in patients treated with Soliris and vaccinated with Bexsero found that the reporting rate for low hemoglobin was 1 case per month in the year before vaccination, 16 per month in the 30 days following vaccination, and less than 1 per month more than 30 days after vaccination. The risk was highest when patients already being treated with Soliris received a dose of Soliris within 2 weeks after being vaccinated with Bexsero.

Conclusions and Actions

  • A review of the reports for patients treated with Soliris concluded that there was an increased risk of anemia or the destruction of red blood cells (hemolysis) when patients already receiving Soliris were vaccinated with Bexsero.
  • The manufacturer has updated the Canadian product information for Soliris to include the risk of hemolysis with vaccines against Neisseria meningitidis serogroup B. To minimize the risk of hemolysis, the manufacturer recommends that patients who are already being treated with Soliris should only be vaccinated when their disease is controlled and the Soliris concentration in the blood is high.
  • Health Canada will continue to monitor side effect information involving Soliris and Bexsero, 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 was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of Soliris and Bexsero in Canada and internationally.

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