🇨🇦 TZIELD (teplizumab) and the Risk of Viral Reactivation

Hazard/Reason: Serious and life-threatening cases of viral reactivation, including Epstein–Barr virus (EBV) and cytomegalovirus (CMV), have been reported with TZIELD. Audience Healthcare professionals including pediatric and adult endocrinologists, diabetologists, internal medicine practitioners, infectious-disease specialists, pediatricians, general practitioners, nurse practitioners, hospital and community pharmacists, and diabetic centre nurses. Key messages Serious and life-threatening cases of viral reactivation, including Epstein–Barr virus (EBV) and cytomegalovirus (CMV), have been reported with TZIELD. Patients who are immunocompromised are at increased risk of viral reactivation. TZIELD is now contraindicated in patients with an active viral infection (including EBV or CMV), any active serious infection, or who are immunocompromised. Healthcare professionals are advised to follow the recommendations for EBV and CMV screening and monitoring, and TZIELD discontinuation in the event of confirmed infection or prolonged severe lymphopenia (see the Information for healthcare professionals section). The Canadian Product Monograph for TZIELD has been updated to include this safety information. Background TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes. As an immunomodulatory agent, TZIELD affects lymphocyte populations, which may increase the risk of serious infections, including viral reactivation. Individuals who are immunocompromised are at increased risk. Serious and life-threatening cases of viral reactivation, including EBV and CMV, have been reported with TZIELD in the post-market setting. Most cases occurred within 2 months following the last infusion. Some of the cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Cases of EBV-associated lymphoproliferative disorder may occur in individuals treated with TZIELD receiving concomitant immunosuppressive therapy and/or with conditions associated with immunologic impairment.  Information for consumers TZIELD is used to delay the onset of Stage 3 type 1 diabetes in adults and children 8 years of age and older who have Stage 2 type 1 diabetes. In Stage 3, the body cannot make enough insulin on its own, and insulin injections may be needed. TZIELD works by slowing down the autoimmune response involved in type 1 diabetes. Because TZIELD affects the immune system, certain infections may occur or become active again during or after treatment. Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in the body after an initial infection. TZIELD may cause these viruses to become active again which, especially in people with a weakened immune system, can become serious and potentially life-threatening. These infections may occur during treatment with TZIELD or up to 2 months after the last dose. Patients should: Tell their healthcare professional right away if they develop symptoms of infection, such as fever, swollen glands, or fatigue during or after TZIELD treatment. Not stop their TZIELD treatment without consulting their healthcare professional. Speak to their healthcare professional if they have any questions or concerns about this information. Information for healthcare professionals Healthcare professionals are advised that:  TZIELD is now contraindicated in patients who have an active viral infection (including EBV or CMV), any active serious infection, or who are immunocompromised. Prior to initiating treatment with TZIELD, patients should be evaluated for active EBV and CMV infection, with an undetectable viral load confirmed (e.g., polymerase chain reaction testing), in addition to existing pre-treatment laboratory evaluations. Patients should be monitored for signs and symptoms of infection (including viral reactivation) during TZIELD treatment and fo

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