Health Canada Warning: SOLIRIS (eculizumab) - Increased Risk of Hemolysis or Low Hemoglobin with Serogroup B Meningococcal Vaccination

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SOLIRIS (eculizumab) - Increased Risk of Hemolysis or Low Hemoglobin with Serogroup B Meningococcal Vaccination

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Starting date: October 25, 2016 Posting date: October 25, 2016 Type of communication: Dear Healthcare Professional Letter Subcategory: Biologic/vaccine Source of recall: Health Canada Issue: Important Safety Information Audience: Healthcare Professionals, General Public Identification number: RA-60752

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Audience

Healthcare professionals (nephrologists, hematologists, hematologist-oncologists, pediatricians, hospital pharmacists, nurses)
Key messages

• An increased risk of hemolysis or low hemoglobin has been observed when patients already being treated with SOLIRIS (eculizumab) were vaccinated against serogroup B meningococcal infection with Bexsero.
• To minimize the risk of hemolysis when patients who are being treated with SOLIRIS are vaccinated, it is recommended that these patients be vaccinated only after their disease has been controlled and within one week following SOLIRIS infusion, when the SOLIRIS concentration in the blood is considered to be relatively high.
• It is recommended that :
  • Unless the risks of delaying SOLIRIS therapy outweigh the risks of developing a meningococcal infection, all patients must be vaccinated with a meningococcal vaccine (against serotypes A, C, Y, W135, and B) prior to, or at the time of, initiating SOLIRIS.
  • Patients who have initiated treatment with SOLIRIS less than 2 weeks after receiving a meningococcal vaccine be treated with appropriate prophylactic antibiotics for a period of 2 weeks post vaccination.
• The Canadian Product Monograph has been updated to include this new safety information...

Read More: http://healthycanadians.gc.ca/recall...60752a-eng.php