Export

ATC codes: P01BA02
Indication
Cutaneous lupus erythematosus of unspecified type ICD11 code: EB5Z
INN
Hydroxychloroquine
Medicine type
Chemical agent
List type
Complementary
Formulations
Oral > Solid: 200 mg (as sulfate)
EML status history
First added in 2021
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Expert Committee recommendation
The Expert Committee noted the reported prevalence of cutaneous lupus erythematosus and the fact that in its active form, it may lead to permanent damage (depigmentation and/or scarring) and is associated with considerable morbidity and impairment of quality of life. The Committee also noted that the current listing for hydroxychloroquine on the Model List is limited to use in children for the treatment of systemic lupus erythematosus, and that ophthalmological monitoring is recommended as a condition for its use. The Committee took into consideration that the approach to treating cutaneous lupus erythematosus is influenced by the subtype of disease and the presence of underlying systemic lupus erythematosus. The first-line therapy typically includes photoprotection and topical or intralesional corticosteroids, topical calcineurin inhibitors, systemic glucocorticoids and systemic antimalarial agents. The Committee noted that hydroxychloroquine showed better efficacy than placebo in treatment of cutaneous lupus erythematosus, and similar efficacy and a better safety profile than acitretin and chloroquine. The main safety issues with hydroxychloroquine include cardiotoxicity and an increased risk of irreversible retinopathy, affecting up to 7% of patients who use higher doses and who continue treatment for a longer time (several years). The Committee acknowledged the dosage recommendations in international guidelines to minimize the risk of retinal toxicity. The Expert Committee considered hydroxychloroquine to have an overall favourable benefit-to-risk ratio for use in the treatment of adults with cutaneous lupus erythematosus, to be generally affordable and widely available. Therefore, the Committee recommended its inclusion on the complementary list of the EML for this indication. In addition, the Committee also recommended hydroxychloroquine be included on the complementary list of the EML for the treatment of systemic lupus erythematosus in adults, given its beneficial effects on this condition. As was the case for listing on the EMLc, the Committee also recommended that the availability of ophthalmological monitoring be a condition for use in adults.