Other safety alerts
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| Canada: Summary Safety Review - Jakavi (ruxolitinib) - Assessing the potential risk of drug interactions with P-glycoprotein (P-gp) substrates (including rosuvastatin) |
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Health Canada announces that it reviewed the potential risk of a drug interaction between ruxolitinib and rosuvastatin (a P-gp substrate) after receiving a Canadian report of a suspected interaction between these 2 drugs. The report included a description of a suspected mechanism of interaction, which prompted Health Canada to include other drugs known to utilize the same transport mechanism, known as P-gp, in the safety review. The current product information for ruxolitinib states that ruxolitinib has no effect on P-gp transporters, based on earlier laboratory studies.
At the time of the review, Health Canada had received 1 Canadian report of increased blood cholesterol due to a potential interaction between ruxolitinib and rosuvastatin. The review of this case could not conclude whether ruxolitinib interacted with rosuvastatin and/or played a role in the increased blood cholesterol observed in the patient. This is because patients with polycythemia vera may develop higher blood cholesterol levels when their disease is being treated. The review also looked at 2 articles in the published literature which did not suggest an interaction between ruxolitinib and other drugs that are known to be transported by P-gp (e.g. digoxin, dabigatran and cyclosporine). Available evidence at the time of review suggested that an interaction between ruxolitinib and rosuvastatin was unlikely because ruxolitinib did not appear to inhibit P-gp at doses typically used in patient treatment. Neither rosuvastatin nor ruxolitinib appear to directly interact with P-gp transporters.
Health Canada's review concluded that the available evidence does not suggest an interaction between ruxolinitib and rosuvastatin or other drugs that are transported by P-gp. Therefore, it is unlikely that any observed increase in blood cholesterol was due to a ruxolitinib interaction with rosuvastatin in the Canadian report. The safety information for these products is appropriate at this time.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00212
In Hong Kong, there are 3 registered pharmaceutical products containing ruxolitinib, namely Jakavi Tab 20mg (HK-61972), Jakavi Tab 15mg (HK-61974) and Jakavi Tab 5mg (HK-61973). All products are registered by Novartis Pharmaceuticals (HK) Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 17 cases of adverse drug reaction related to ruxolitinib, but these cases are not related to drug interaction. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Thursday, Oct 11, 2018
Issued at HKT 15:00
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