Prolia experience across all 6 indications1,2
PATIENTS IN CANADA
Prolia (denosumab injection) is indicated:2
for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral and hip fractures.
as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
as a treatment to increase bone mass in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT), who are at high risk for fracture.
as a treatment to increase bone mass in women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor (AI) therapy, who have low bone mass and are at high risk for fracture.
as a treatment to increase bone mass in women and men at high risk for fracture due to sustained systemic glucocorticoid therapy.
as a treatment to increase bone mass in women and men at high risk for fracture who are starting or have recently started long-term glucocorticoid therapy.
Click here for additional safety information and a link to the product monograph discussing:
Contraindications in patients with a hypersensitivity to the drug or any component of the product, patients with hypocalcemia and patients who are pregnant or trying to become pregnant.
Relevant warnings and precautions regarding concomitant use with XGEVA®, adequate intake of calcium and vitamin D, hypercalcemia reported in clinical trials in pediatric patients with osteogenesis imperfecta (some cases required hospitalization and were complicated by acute renal injury), hypocalcemia including severe cases and clinical monitoring of calcium levels during treatment, increased risk of hypocalcemia in patients with severe renal impairment or in patients on dialysis, serious infections, epidermal and dermal adverse events, osteonecrosis of the jaw (ONJ), atypical femoral fractures, multiple vertebral fractures following discontinuation of treatment, significant suppression of bone remodelling, potential for greater sensitivity in older patients, not recommended in nursing women or pediatric patients, potential for female partner and fetal exposure unlikely when taken by men, latex sensitivity, hypersensitivity vasculitis, drug reaction with eosinophilia and systemic symptoms (DRESS), and musculoskeletal pain.
Conditions of clinical use, adverse reactions, drug interactions and dosing instructions.
See fracture incidence and BMD Data.Prolia Efficacy
|1.||Data on file. Amgen Canada Inc.|
|2.||Prolia Product Monograph. Amgen Canada Inc., December 29, 2022.|