Australian Doctor Australian Doctor 3rd November 2017 | Page 7

SHE’S PROLIA PROTECTED ® * * Prolia ® reduces the risk of osteoporotic fracture compared with placebo 1–3 nthly confidenc o e 6-m 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.