Indications and clinical use:1
Prolia (denosumab injection) is indicated:
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.
Prolia is not indicated for use in pediatric patients.
Hypersensitivity to the drug or any ingredient in the formulation, including any non-medicinal ingredient or component of the container. Anaphylactic reactions have been reported.
Patients who are pregnant or trying to become pregnant. Verify the pregnancy status of women of reproductive potential prior to initiating Prolia. Advise them that Prolia may cause fetal harm when administered to a pregnant woman and to use effective contraception during therapy and for at least 5 months after the last dose of Prolia.
Relevant Warnings and Precautions
Contains same active ingredient as XGEVA®; do not use concurrently
Adequate intake of calcium and vitamin D is important in all patients
Hypercalcemia has been reported in clinical trials in pediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalization and were complicated by acute renal injury.
Hypocalcemia, including severe cases; clinical monitoring of calcium levels is recommended; follow standard medical care guidelines for signs and symptoms
In severe renal impairment or dialysis, there is a greater risk of hypocalcemia; adequate intake of calcium and vitamin D is important
Epidermal and dermal adverse events
Osteonecrosis of the jaw (ONJ); risk may increase with duration of exposure to Prolia; evaluate for ONJ risk factors before starting treatment; dental examination is recommended for those with risk factors; good oral hygiene practices should be maintained during treatment and invasive dental procedures should be avoided
Atypical femoral fractures
Multiple vertebral fractures following discontinuation of Prolia treatment
Significant suppression of bone remodelling
Potential for greater sensitivity in older patients
Not recommended in nursing women
Potential for female partner and fetal exposure unlikely when taken by men
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Musculoskeletal pain, including severe cases
For more information:
Please consult the Product Monograph at www.amgen.ca/Prolia_PM.pdf for important information relating to adverse reactions, drug interactions and dosing.
The Product Monograph is also available by calling us at 1-866-502-6436.
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|1.||Prolia Product Monograph. Amgen Canada Inc., December 21, 2022.|