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Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis
2023.12.14
Active substance: miltefosine
The company Paesel und Lorei GmbH & Co. KG, in agreement with the Federal Institute for Drugs and Medical Devices (BfArM), inform about case reports in which complications in the eye (including keratitis) were described during treatment with miltefosine. In most cases, these occurred after more than 28 days of treatment. A new warning has been added to the product information: Before starting treatment, an eye examination should be considered and a history of eye disease should be recorded.
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