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.

Clinical use:

Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Prolia in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

Contraindications

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.

Hypocalcemia

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

Serious infections

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

Hypersensitivity vasculitis

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 further details regarding the Warnings and Precautions, as well as important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.

The Product Monograph is also available by calling Amgen at 1-866-502-6436.