Important Information on Plaquenil® (hydroxychloroquine)
Australia, 4 June 2020 – Australia, 4 June 2020 – There has been increased media coverage around the off-label use of hydroxychloroquine in the management of COVID-19. The situation is raising some questions from our different stakeholders.
Patient safety is the priority
To date there is insufficient clinical evidence to draw definite conclusions over the clinical efficacy or safety of hydroxychloroquine in the management of 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; dental, 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.
On 1 May 2020, Pharmaceutical Benefits Scheme (PBS) listings for all hydroxychloroquine brands, including Plaquenil, were amended to restrict prescribing for the treatment of the TGA approved indications. The initial prescription was also restricted to medical specialists in dermatology, intensive care medicine, paediatrics and child health physician, or emergency medicine.
Several updates to Section 4.5 Interactions with other medicines and other forms of interactions of the Australian Product Information (PI) have also recently been implemented.
Ensure supply continuity
One of our top priorities is to ensure supply continuity for use of Plaquenil® in the current indications.
For medical information or questions: Please contact the Sanofi Australia’s Medical Information Helpline from 8am – 6pm AEST Monday – Friday: 1800 818 806