Prolia Treatment - Safety Analysis | Osteoporosis

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

The yearly exposure-adjusted participant incidence of adverse events remained similar between Prolia^® and placebo, and remained low with long-term treatment.¹

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

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.

Bone HG, et al. Lancet Diabetes Endocrinol. 2017;5:513–23.
Smith MR, et al. N Engl J Med. 2009;361:745–55.
Gnant M, et al. Lancet. 2015;386:433–43.
Prolia^® (denosumab) Summary of Product Characteristics. Amgen. Last revised December 2020.

SMPC

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

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