Important Information on Plaquenil® and COVID-19
Australia, 26 March 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.
Today in Australia, Plaquenil® (hydroxychloroquine) is registered in rheumatoid arthritis, mild systemic and discoid lupus erythematosus and the suppression and treatment of malaria.
Any use of this medicine in the management of COVID-19 is considered an off-label use (i.e. in absence of a marketing authorisation for the indication of COVID-19).
On 24 March 2020 the Therapeutic Goods Administration made changes that support on label prescribing of this product in Australia. These changes mean that:
• Initiation of hydroxychloroquine is now restricted to the following medical specialties as per the Medical Board list: dermatology; intensive care medicine; paediatrics and child health; physician; and emergency medicine.
• General practitioners and other medical practitioners (e.g. hospital Resident Medical Officers (RMOs) and doctors in training) can continue to prescribe repeats for hydroxychloroquine to patients in line with the registered indications for patients in whom the medication was prescribed prior to 24 March 2020.
• General practitioners and doctors in training can prescribe these medicines for continued treatment of patients where treatment was previously initiated by one of the specialists.
Ensure supply continuity
One of our top priorities is to ensure supply continuity for use of Plaquenil® in the current indications.
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® current registrations and indications.
For medical information or questions: Please contact the Sanofi Australia’s Medical Information Helpline from 8am – 6pm AEST Monday – Friday: 1800 818 806