Safety and Effectiveness of Molnupiravir (LAGEVRIO^®) Capsules in Japanese Patients with COVID-19: Interim Report of Post-marketing Surveillance in Japan.

ABSTRACT:

Introduction

Molnupiravir is an oral antiviral drug that received special approval for emergency use in Japan on December 24 2021 for infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This post-marketing surveillance (PMS) is underway to investigate the safety and effectiveness of molnupiravir in daily clinical practice in Japan. The interim PMS data collected from December 27 2021 to June 15 2022 are reported in this publication.

Methods

This survey included adult Japanese patients treated with molnupiravir. For safety, adverse drug reactions (ADR) were assessed by physicians. Effectiveness was assessed by the composite endpoint of (1) hospitalization or (2) death in outpatients and by the composite endpoint of (3) death or (4) initi

SUBMITTER: Kimata M 

PROVIDER: S-EPMC10018610 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature