Prolia Treatment - Safety Analysis | Osteoporosis | Amgen

PROLIA®IS WELL TOLERATED FOR UP TO 10 YEARS OF TREATMENT1

In the FREEDOM trial and open-label extension, the incidence rates of adverse events for long-term and crossover Prolia® remained low.1
Find out more about FREEDOM here.
FREEDOM trial data reporting fracture incidents for 10 years.
Data are yearly exposure-adjusted participant incidence of adverse events per 100 participant-years of follow-up for placebo and for Prolia® in the combined FREEDOM, long-term, and crossover participants who experienced ≥1 adverse event. Placebo data are for all participants who received at least one dose of placebo during the FREEDOM trial. Prolia® data are for all participants who received at least one dose of Prolia® during the FREEDEOM trial or extension. Data are shown for each year of exposure; therefore, a long-term participant could have up to 10 years of exposure and a crossover participant could have up to 7 years of exposure to Prolia®. All adverse events and serious events were coded using the Medical Dictionary for Regulatory Activities version 13.0.1
The benefit/risk profile of Prolia® remains favorable in an ageing population of postmenopausal women, as well as in patients with non-metastatic breast or prostate cancer receiving hormone ablation therapy.1–3
Click here to read more on special warnings and contraindications associated with Prolia® treatment.
Uncommon cases of cellulitis, rare cases of hypocalcaemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures have been observed in patients taking Prolia®.4

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The yearly exposure-adjusted participant incidence of adverse events remained similar between Prolia® and placebo, and remained low with long-term treatment.1
Adverse events
Data are yearly exposure-adjusted participant incidence of adverse events per 100 participant-years of follow-up for placebo and for Prolia® in the combined FREEDOM, long-term, and crossover participants who experienced ≥1 adverse event. Placebo data are for all participants who received at least one dose of placebo during the FREEDOM trial. Prolia® data are for all participants who received at least one dose of Prolia® during the FREEDEOM trial or extension. Data are shown for each year of exposure; therefore, a long-term participant could have up to 10 years of exposure and a crossover participant could have up to 7 years of exposure to Prolia®. All adverse events and serious events were coded using the Medical Dictionary for Regulatory Activities version 13.0.1
Adverse reactions reported from Phase II and III clinical trials in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation.4
Very common (may affect >1 in 10 patients)
  • Pain in extremity
  • Musculoskeletal pain (including severe cases)
Uncommon (may affect up to 1 in 100 patients)
  • Diverticulitis
  • Cellulitis
  • Ear infection
  • Lichenoid drug eruptions
Common (may affect up to 1 in 10 patients)
  • Urinary tract infection
  • Upper respiratory tract infection
  • Sciatica
  • Constipation
  • Abdominal discomfort
  • Rash
  • Eczema
  • Alopecia
Rare (may affect up to 1 in 1,000 patients)
  • Drug hypersensitivity
  • Anaphylactic reaction
  • Hypocalcaemia
  • Osteonecrosis of the jaw
  • Atypical femoral fractures
Not known
  • Osteonecrosis of the external auditory canal

Descriptions of adverse events and the complete Prolia® Summary of Product Characteristics can be found here.

References:
AE: adverse event; AFF: atypical femoral fracture; ONJ: osteonecrosis of the jaw.
  1. Bone HG, et al. Lancet Diabetes Endocrinol. 2017;5:513–23.
  2. Smith MR, et al. N Engl J Med. 2009;361:745–55.
  3. Gnant M, et al. Lancet. 2015;386:433–43.
  4. Prolia® (denosumab) Summary of Product Characteristics. Amgen. Last revised February 2020.

SMPC

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