ADR that result in revision of patient information
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| Canada: KEYTRUDA (pembrolizumab) - Risk of severe skin reactions: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis |
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Health Canada advised that cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with fatal outcomes, have been reported in patients treated with KEYTRUDA (pembrolizumab). Health Canada is currently working with the manufacturer to include this safety information in the Canadian Product Monograph.
KEYTRUDA (product for intravenous use) is a programmed death receptor-1 (PD-1) blocking antibody. In Canada, it is indicated for the treatment of patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. KEYTRUDA is also authorized under the notice of compliance with conditions (NOC/c) policy for the treatment of patients with:
• unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.
• metastatic non-small cell lung carcinoma (NSCLC) whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy.
The potential risk of SJS and TEN with KEYTRUDA use was evaluated using currently available safety data from the published literature and the manufacturer’s global safety database (which includes both clinical trial serious adverse events and post-marketing reports). One fatal case of SJS in a clinical trial and one fatal case of TEN in the post-marketing setting have been reported internationally in patients treated with KEYTRUDA. Including these cases, there have been 8 cases of SJS (6 in clinical trials, and 2 post-marketing) and 2 of TEN (both post-marketing). Of these 10 reports, one case of SJS was reported in Canada. Two of the 10 reports had a temporal association with KEYTRUDA use, had few confounding factors, and had skin biopsies that were consistent with SJS or TEN. Approximately 11,000 patients in clinical trials and 27,000 patients in the post-marketing setting have been treated with KEYTRUDA.
Patients are advised that SJS and TEN are serious life-threatening conditions that often involve wide areas of the skin, the eyes, and lining of the mouth, nose, throat, or genital area. Flu-like symptoms including fever, tiredness, muscle and joint pain are seen early which are followed by a widespread rash and reddening and blistering of the skin and moist lining of the mouth, nose, throat, or genital area. This often leads to peeling and shedding of the affected skin which looks like a severe burn. Patients should seek immediate medical attention if they experience any of these symptoms.
Health Canada reminds healthcare professionals to:
• advise patients about the benefits and risks of KEYTRUDA, including the risk and early symptoms of SJS and TEN.
• suspend KEYTRUDA treatments if SJS, TEN or other severe skin reaction signs or symptoms (Grade 3) occur and refer the patient for immediate specialized evaluation and treatment.
• permanently discontinue KEYTRUDA, if SJS or TEN is confirmed.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../62670a-eng.php
In Hong Kong, Keytruda Solution for Injection 100mg/4ml (HK-64228) and Keytruda Powder for Injection 50mg (HK-64229) are pharmaceutical products registered by Merck Sharp & Dohme (Asia) Ltd, and are prescription only medicines. So far, the Department of Health has received 13 cases of adverse drug reactions in connection with pembrolizumab, of which one case was related to TEN. In view of the above Health Canada announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, March 21, 2017
Issued at HKT 14:00
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