Revise precautions for glatiramer acetate + nivolumab in Japan
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Revise precautions for glatiramer acetate + nivolumab in Japan The precautions in the package inserts for glatiramer acetate and nivolumab should be revised to include various liver-related conditions, says Japan’s PMDA.* Firstly, the PMDA noted that hepatic impairment may occur with glatiramer acetate therapy, and that liver function testing should be performed prior to starting therapy, and periodically thereafter during drug administration. Secondly, the monoclonal antibody nivolumab may be associated with clinically significant adverse reactions – including hepatic failure, hepatic impairment, hepatitis and sclerosing cholangitis. As such, "patients should be carefully monitored through periodic liver function tests", noted the PMDA. All of the above-mentioned adverse reactions and precautions should be revised in the "Important Precautions" and "Adverse Reactions" sections of the package inserts for the respective products, concluded the PMDA. * PMDA = Pharmaceuticals and Medical Devices Agency Pharmaceuticals and Medical Devices Agency of Japan. Revisions of PRECAUTIONS (FY2020): Glatiramer acetate; Nivolumab (genetical recombination). Internet Document 803517542 : 5 Nov 2020. Available from: URL: https://www.pmda.go.jp/english/safety/info-services/drugs/revision-of-precautions/0008.html
0114-9954/20/1831-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
Reactions 21 Nov 2020 No. 1831
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