其 他 安 全 警 示
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| Canada : Opdivo (nivolumab) and Yervoy (ipilimumab) used alone, or in combination - Assessing the potential risk of Hemophagocytic Lymphohistiocytosis (HLH) (English only) |
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Health Canada is announcing that it has completed a safety review of the risk of Hemophagocytic Lymphohistiocytosis (HLH - a condition where a large number of immune cells attack and destroy other blood cells) associated with the use of Opdivo (nivolumab) and/or Yervoy (ipilimumab) following reports of HLH published in medical literature. The review concluded that there may be a link between the use of these products and the development of HLH.
HLH is a life-threatening overreaction of the immune system where a large number of immune cells attack and destroy other blood cells. HLH is characterized by a large release of certain proteins by immune cells in the blood (referred to as a "cytokine storm" or "cytokine release syndrome"), as well as the accumulation of activated immune cells (lymphocytes and macrophages) in organs and tissues.
In the safety review, the Health Canada found that:
- The use of Opdivo and Yervoy (alone or in combination) is known to cause a range of immune-related side effects.
- At the time of the review, Health Canada had received 1 Canadian report of a cancer patient who developed HLH after treatment with Opdivo, in combination with Yervoy. This report was considered serious and involved death.
- Health Canada also looked at 21 international reports of HLH following treatment with Opdivo and Yervoy, either used alone or in combination. All reports were considered serious, and 6 of the 21 involved death.
- Health Canada could not confirm whether the use of Opdivo or Yervoy was the cause of the reported deaths in the Canadian or the international reports.
- Health Canada also looked at the scientific and medical literature. The articles reviewed suggest that there may be a link between the use of drugs that are in the PD-1 inhibitors class (such as Opdivo), and the development of HLH.
- Health Canada's assessment could not rule out a link between Opdivo and Yervoy and the development of HLH.
Health Canada will work with the manufacturer to determine the appropriate changes to the product safety information; and encourages consumers and healthcare professionals to report any adverse reactions related to the use of this, or other health products. It will continue to monitor safety information involving Opdivo and Yervoy, to identify and assess potential harms.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00225
In Hong Kong, there are 2 registered pharmaceutical products containing nivolumab, namely OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/4ML (HK-64231) and OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML (HK-64232); and 2 registered products containing ipilimumab, namely YERVOY CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/10ML (HK63494) and YERVOY CONCENTRATE FOR SOLUTION FOR INFUSION 200MG/40ML(HK-63495); which are registered by Bristol-Myers Squibb Pharma (HK) Ltd, and are prescription-only medicines.
So far, the Department of Health (DH) has received 48 cases of adverse drug reaction (ADR) for nivolumab and 12 cases for ipilimumab, but none of them were related to HLH. The DH will keep vigilant on the further safety updates from the other overseas drug regulatory authorities.
Ends/ Tuesday, June 25, 2019
Issued at HKT 15:30
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