There has been increased media coverage around the off-label use of hydroxychloroquine in the management of COVID-19. The situation is raising many questions.
Plaquenil® (hydroxychloroquine) is registered in approximatively 60 countries under different trade names: Plaquenil®, Quensyl®, and Plaquinol®. Current approved indications (depending on each country) include some dermatological and rheumatological diseases such as lupus and rheumatoid arthritis. In some countries, it is also indicated against malaria.
To date, Plaquenil® is not indicated for use in COVID-19 patients anywhere in the world. Due to the health emergency, governments in some countries are allowing its temporary off-label use in that disease under certain conditions despite the lack of scientific evidence. It is not the case in all countries and healthcare professionals must refer to their national authorities’ official recommendations.
In all countries, even when national guidance/recommendations have been issued, any use of Plaquenil® (hydroxychloroquine) in the management of COVID-19 is an off-label use. Any off-label use must be communicated to local regulatory authorities or the local Sanofi affiliate, whether the patients suffer adverse events or not.
Plaquenil® can cause serious adverse reactions, described below. Therefore, it should be used with caution.
For information about the safety of the medicine, healthcare professionals should consult the current Summary of Product Characteristics as well as their local regulatory authorities’ website. Patients taking hydroxychloroquine-containing medicines, like any other medicines, should follow the instructions provided in the Patient Information Leaflet.
Patients must not take Plaquenil® without medical prescription or advice. They should always consult with their healthcare professionals if they have questions about hydroxychloroquine.
For medical information or questions, patients and healthcare professionals can reach out to the Sanofi affiliate in their country.
To access Sanofi’s local websites, click HERE.
About the Main Side Effects of Plaquenil® (hydroxychloroquine)
The main side effects of hydroxychloroquine are described in the product information. At the recommended daily dose for approved indications, ranging from 200 to 400 mg (without exceeding 600 mg at treatment onset) daily in adults for chronic treatment of autoimmune indications, or up to 2000 mg maximum administered over 3 days in acute treatment of malaria, the most serious side effects of hydroxychloroquine are eye disorders following long term use, including retinopathy, with changes in pigmentation and visual field defects and severe hypoglycemia including loss of consciousness (in patients treated with and without antidiabetic medications). Cardiotoxic effects are rare but serious complications of hydroxychloroquine, which include acute cardiac conduction disorders (QT prolongation, ventricular arrhythmia) have also been observed. Neurological, psychiatric, hepatic, severe skin disorders, allergic reactions have also been described.
Hydroxychloroquine should be used with caution in patients receiving drugs known to prolong the QT interval such as some anti-infectives, e.g. macrolides including azithromycin, due to an increased risk of ventricular arrhythmia that could lead to cardiac arrest.
The risk and severity of side-effects may increase with a higher posology (dosage) of hydroxychloroquine.
For more information about these risks, patients and healthcare professionals must consult their local regulatory authorities’ website.