ISSUE 1 FEBRUARY
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 21 November 2025.
Summary
The Product Information (PI) for denosumab products indicated for the treatment of osteoporosis (Prolia and biosimilars) have been updated to strengthen the existing warning for multiple vertebral fractures (MVF) following discontinuation or delay of treatment.
These denosumab products are used for treatment:
- of osteoporosis in postmenopausal women
- to increase bone mass in men with osteopenia receiving androgen deprivation therapy for non-metastatic prostate cancer
- to increase bone mass in men with osteoporosis at increased risk of fracture
- to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.
Denosumab is subsidised by the Pharmaceutical Benefits Scheme for treatment of osteoporosis.
What health professionals should do
Denosumab is administered as a 6-monthly injection. New vertebral fractures have occurred as early as 7 months after the last dose of denosumab and consideration should be given to switching patients to an alternative antiresorptive therapy if denosumab treatment is discontinued.
Before starting treatment with denosumab, patients should be counselled on the importance of adherence and the risks of MVF if treatment is discontinued or delayed.
Be alert to the need for clear communication between patients and health professionals (including between specialists, general practitioners, dental practitioners and pharmacists) regarding denosumab treatment, including information around treatment interruption or cessation.
Be alert to recent updates to clinical guidance from Healthy Bones Australia (HBA) and the Royal Australian College of General Practitioners (RACGP): Position Statement on the Management of Osteoporosis (November 2025) and Osteoporosis management and fracture prevention in postmenopausal women and men over 50 years of age (March 2024).
These complement the PI changes by reinforcing continuity of denosumab treatment and the need for careful transition planning if denosumab therapy is delayed or discontinued. The revised guidance supports prescribers in minimising the risk of MVF through consistent patient review and adherence to safe management practices.
See the full article on the TGA website.
