Sanofi: Important Information on Plaquenil® and COVID-19

Beirut, March 30,2020 – There has been increased media coverage around the off-label use of hydroxychloroquine in the management of COVID-19 based on preliminary results from independent studies from different countries. The situation is raising many questions from our different stakeholders.

Patient safety is the priority

To date there is insufficient clinical evidence to draw any conclusions over the clinical efficacy or safety of hydroxychloroquine (or chloroquine) in the management of COVID-19. The preliminary results from different independent studies require further analysis and more robust and larger clinical studies to assess the patient benefit/risk profile of Plaquenil® in COVID-19.

Plaquenil® (hydroxychloroquine) is not registered in Lebanon.

Any use of this medicine in the management of COVID-19 is considered an off-label use (i.e. in absence of a marketing authorization for the indication of COVID-19).

The labeling of the product to be used in Lebanon is the Irish labelling. Plaquenil® is indicated in adults for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight , and in children for the treatment of juvenile idiopathic arthritis in combination with other therapies , in most of the countries where its registered.

Ensure supply continuity

One of our top priorities is to ensure supply continuity for use of Plaquenil®.

Sanofi is working with local health authorities and scientific experts in different countries impacted by the outbreak in order to investigate the patient benefit/risk profile of Plaquenil® (hydroxychloroquine) in the treatment of COVID-19 and if requested by the local governments and / or health authorities, to provide or donate the product. Sanofi has the manufacturing capacity to increase production while maintaining appropriate supply levels for Plaquenil as per the request of the Ministry of Health – Lebanon

At their request, Sanofi donated doses of hydroxychloroquine medicine to the Lebanese government.

For medical information or questions: Please contact the Sanofi Medical Information Generic Mailbox at: Levant.Medinfo@sanofi.com

For pharmacist information or questions: Please contact the Sanofi Medical Information Generic Mailbox at: Levant.Medinfo@sanofi.com

IMPORTANT SAFETY REMINDER ABOUT PLAQUENIL®

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, 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, hepatic, severe skin disorders, allergic reactions, hypoglycemia 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.

The risk and severity of side-effects may increase with a higher posology (dosage) of hydroxychloroquine.

Healthcare professionals should consult the current Summary of Product Characteristics for the most up to date safety information. 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.

Sanofi is asking local Health Authorities to communicate a clear position regarding current lack of robust clinical data for the use of Plaquenil®, in the management of COVID-19, emphasizing that such use will be off-label, and to communicate the known serious adverse reactions associated with Plaquenil®, namely the contraindications in patients with known hypersensitivity to 4-aminoquinoline compounds; with pre-existing maculopathy of the eye; below 6 years of age (200mg tablets not adapted for weight <35 kg) and the risk of retinal toxicity, hypoglycemia and cardiac toxicity as well as the known risk of interactions. Sanofi also requests that all off-label use is communicated to the Sanofi affiliate pharmacovigilance team at Levant.Pharmacovigilance@sanofi.com or the national spontaneous reporting system, whether or not the patients suffer adverse events.