Important Information on Plaquenil® (hydroxychloroquine) and COVID-19
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
IMPORTANT SAFETY REMINDER ABOUT PLAQUENIL®
In Australia, Plaquenil® (hydroxychloroquine) is registered in rheumatoid arthritis, mild systemic and discoid lupus erythematosus and the suppression and treatment of malaria.
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 based on body weight (and without exceeding 1550 mg base in adults) 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, 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 Product Information for the most up to date safety information. Patients taking hydroxychloroquine-containing medicines, like any other medicines, should follow the instructions provided in the Consumer Medicine Information.
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 Australia Pharmacovigilance Team at firstname.lastname@example.org or on (02) 8666 2123, or directly to the TGA at www.tga.gov.au/reporting-problems.