PD-1 Drug Safety Information: PMDA Adds Warning for Nivolumab
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
- November 24, 2015
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Information as of November 24, 2015:
Japan's PMDA (Pharmaceuticals and Medical Devices Agency / 独立行政法人 医薬品医療機器総合機構) has added new precautions to the prescribing information for nivolumab.
[Type 1 Diabetes] Patients with Type 1 diabetes (including fulminant Type 1 diabetes mellitus, FT1DM) may develop diabetic ketoacidosis. Symptoms include thirst, nausea, vomiting, or elevated blood glucose — please monitor carefully. If Type 1 diabetes is suspected, discontinue use and initiate appropriate management such as insulin therapy.
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