PROLIA® (International English)

Prolia® is a prescription biologic containing denosumab, a fully human IgG2 monoclonal antibody and RANKL inhibitor developed by Amgen and FDA-approved in June 2010 for osteoporosis and hormone ablation-related bone loss.

No. Prolia® inhibits RANKL extracellularly, and its effect fully reverses after discontinuation. It is mechanistically and clinically distinct from bisphosphonates, which bind to bone and retain activity after dosing stops.

Prolia® is indicated for postmenopausal women with osteoporosis at high risk for fracture, men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis, and increasing bone mass in patients at high risk for fracture receiving ADT for nonmetastatic prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer.

Prolia® is given as a 60mg subcutaneous injection every six months by a healthcare professional, with daily calcium 1,000mg and vitamin D 400 IU throughout treatment.

The most common adverse reactions in postmenopausal osteoporosis trials were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Serious risks include hypocalcemia, ONJ, atypical femoral fractures, serious infections, and severe musculoskeletal pain.

Onset varies; severe, symptomatic hypocalcemia most commonly emerges between 2 and 10 weeks post-injection, particularly in patients with advanced CKD, severe renal impairment, or low baseline calcium levels.

Alopecia is listed as a common adverse reaction in the EU SmPC but is absent from the most common adverse reactions in the U.S. prescribing information summary; consult the labeling relevant to your jurisdiction.

Jubbonti (denosumab-bbdz) is an FDA-approved interchangeable biosimilar to Prolia® (approved in March 2024, marketed by Sandoz) with the same molecule, indications, and dosing. The interchangeable designation permits pharmacy-level substitution under applicable state law. Unlike Prolia®, Jubbonti is integrated into a REMS program to reinforce safety protocols regarding severe hypocalcemia in renal impairment.\

For licensed medical professionals only. This content is for informational purposes only and does not constitute medical advice.