Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.

ABSTRACT:

Objective

Tacrolimus, a macrolide immunosuppressant, is approved in Korea for the treatment of rheumatoid arthritis (RA), lupus nephritis (LN) and myasthenia gravis (MG) We report three prospective post-marketing surveillance studies of tacrolimus conducted in South Korea in these indications.

Methods

Studies were conducted according to South Korean Ministry of Food and Drug Safety requirements Patients were followed up for the duration of the study (up to 4 years) or until treatment discontinuation Occurrence and likely relationship with tacrolimus of adverse events (AEs), adverse drug reactions (ADRs; defined as AEs where causal relationship to tacrolimus could not be excluded) and serious AEs were recorded Association of AEs with demographic and medical factors was evalua

SUBMITTER: Yoo WH 

PROVIDER: S-EPMC10324909 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature