6-monthly confidence
With demonstrated reductions in fracture risk compared with placebo, 1 – 3 you can feel confident that each dose of Prolia offers 6 months of protection.
®
SHE’ S PROLIA
PROTECTED *
* Prolia ® reduces the risk of osteoporotic fracture compared with placebo 1 – 3
6-monthly confidence
1 – 3
With demonstrated reductions in fracture risk compared with placebo, 1 – 3 you can feel confident that each dose of Prolia offers 6 months of protection.
Before prescribing please review the full product information available from www. amgen. com. au / Prolia. PI
For more information on Prolia ® or to report an adverse event involving Prolia ®, please contact Prolia ® Medical Information on 1800 646 998.
PBS Information: Authority required( STREAMLINED) as treatment for osteoporosis. Refer to PBS Schedule for full information.
PROLIA MINIMUM PRODUCT INFORMATION. INDICATIONS: Treatment of osteoporosis in postmenopausal women to reduce risk of vertebral, non-vertebral and hip fractures. Treatment to increase bone mass in men with osteoporosis at increased risk of fracture. CONTRAINDICATIONS: Hypocalcaemia. Hypersensitivity to denosumab, CHO-derived proteins or any component. Pregnancy and in women trying to get pregnant. PRECAUTIONS: Correct hypocalcaemia prior to initiating therapy. Monitor calcium in patients predisposed to hypocalcaemia. Adequate intake of calcium and vitamin D is important. Evaluate patients for risk factors for osteonecrosis of the jaw( ONJ); use with caution in these patients. Very rare reports of atypical femoral fractures. Multiple vertebral fractures may occur following discontinuation. ADVERSE EFFECTS: Hypocalcaemia, skin infections( predominantly cellulitis) and pancreatitis. DOSAGE AND ADMINISTRATION: Single subcutaneous injection of 60 mg, once every 6 months. Ensure adequate intake of calcium and vitamin D. No dose adjustment required in the elderly or in renal impairment. PRESENTATION: Pre-filled syringe with automatic needle guard. References: 1. Prolia ®( denosumab) Approved Product Information, available at www. amgen. com. au / Prolia. PI. 2. Cummings SR, et al. N Engl J Med 2009; 361:756 – 65. 3. Papapoulos S, et al. Osteoporos Int 2015; 26:2529 – 58. Prolia ® is a registered trademark of Amgen. Amgen Australia, Level 7, 123 Epping Road, North Ryde, NSW 2113, ABN 31 051 057 428. www. amgen. com. au. AU-07987 Approved August 2017.