Safety Profile

Prolia was generally well tolerated up to 10 years in patients with postmenopausal osteoporosis.

Adverse events with Prolia in the extension study (total 10 years, n=2,343) were similar to those observed at 3 years (n=3,886)1

AE Rate Graph

Additional important safety information

  • Prolia is contraindicated in female patients who are pregnant or trying to become pregnant, patients with hypocalcemia, or who are hypersensitive to the drug or any component of the product. Anaphylactic reactions have been reported. For a complete listing, see the dosage forms, composition and packaging section of the Product Monograph.1
  • The safety and efficacy of Prolia have not been studied in pediatric populations. Prolia is not indicated for use in pediatric patients.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.1
  • Prolia (denosumab injection) is also indicated 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.1
  • Adequate intake of calcium and vitamin D is important in all patients including patients with severe renal impairment or receiving dialysis.1
  • Patients being treated with Prolia should not receive XGEVA®.1

Physicians should note the following warnings and precautions:

  • In the FREEDOM trial, serious infections leading to hospitalizations were reported more frequently in the Prolia group (4.1%) than in the placebo group (3.4%).1
  • Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis and erysipelas.1
  • Epidermal and dermal events including dermatitis, eczema and rashes occurred at a significantly higher rate in the Prolia group (10.8%) than in the placebo group (8.2%). Consider discontinuing Prolia if severe symptoms develop.1
  • Osteonecrosis of the jaw (ONJ) has been reported in patients treated with Prolia or bisphosphonates. The risk of ONJ may increase with duration of exposure to Prolia. A dental examination with appropriate preventative dentistry should be considered in patients with risk factors for ONJ. Avoid invasive dental procedures during treatment with Prolia. For patients in whom invasive dental procedures cannot be avoided, the clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. Patients who are suspected of having ONJ or patients who develop ONJ during treatment should receive care by a dentist or an oral surgeon. I patients who develop ONJ during treatment with Prolia, a temporary interruption of treatment should be considered based on individual benefit/risk assessment until the condition resolves.1
  • Atypical femoral fractures have been reported in patients receiving Prolia. Patients should be advised to report any new or unusual thigh, hip or groin pain.1
  • Multiple vertebral fractures may occur following discontinuation of treatment with Prolia. Advise patients not to interrupt Prolia therapy without their physician’s advice. Evaluate the individual benefit/risk before discontinuing treatment with Prolia. If Prolia treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.1
  • Treatment with Prolia resulted in significant suppression of bone remodelling. The significance of these findings and the effect of long-term treatment with Prolia are unknown. Monitor patients for ONJ, atypical fractures and delayed fracture healing.1
  • Please see Product Monograph for complete Warnings and Precautions, Dosage and Administration. Physicians should become fully familiarized with the efficacy data/safety profile of Prolia and the full content of the Product Monograph prior to prescribing the drug.
References

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