March 21, 2017 – Health Canada just communicated this important safety information: Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) under treatment of patients with Pembrolizumab (Keytruda) have been reported internationally in the clinical trials and post-marketing setting. There were 8 cases of SJS (1 of them with a fatal outcome) and 2 cases of TEN (1 of them with a fatal outcome). Of these reports, one case of SJS was reported in Canada.
Risk of severe if not fatal skin reactions with Pembrolizumab (Keytruda)
Healthcare professionals including oncologists, nurses, hospital pharmacists, emergency room staff, and cancer clinic staff should i) counsel patients about the benefits and risks of Pembrolizumab (Keytruda), including the risk and early symptoms of SJS and TEN, ii) suspend Pembrolizumab (Keytruda) treatment and refer for immediate specialized evaluation and treatment if a patient reports any severe skin reaction, or in a case of suspected SJS or TEN, and iii) permanently discontinue Pembrolizumab (Keytruda) if SJS or TEN is confirmed. Patients should inform their healthcare professional if they are experiencing a side effect related to Pembrolizumab (Keytruda) use, and both, healthcare professionals and patients alike may report any case of severe skin reactions or suspected SJS or TEN or any other serious or unexpected side effects when receiving Pembrolizumab (Keytruda) to Merck Canada Inc. or Health Canada since managing marketed health product-related side effects largely depends on these contributions. These are the addresses: Merck Canada Inc., Pharmacovigilance 16750 Trans -Canada Hwy. Kirkland, Québec, H9H 4M7 Fax.: 1-800-3693090 Marketed Health Products Directorate E-mail: email@example.com Telephone: 613-964-6522 Fax: 613-952-7738 You can report any suspected adverse reactions associated with the use of health products to Health Canada by i) calling toll-free at 1-866-234-2345, or by ii) Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.Outside of Canada, healthcare professionals and patients alike may report any case of severe skin reactions or suspected SJS or TEN or any other serious or unexpected side effects when receiving Pembrolizumab (Keytruda) to their country specific Merck (or Merck, Sharp & Dohme (MSD) where it applies) Pharmacovigilance Center or to the county specific registration authority’s Pharmacovigilance Center.