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.