What is Prolia (Denosumab) used for?

Prolia (Denosumab) is used to treat postmenopausal osteoporosis, loss of bone mass in women receiving aromatase inhibitor therapy for breast cancer, and in men with prostate cancer receiving hormone adjuvant therapy.

Denosumab is a fully human monoclonal antibody (IgG2), which has high affinity and specificity for the ligand of the nuclear factor activator receptor ?B (RANKL), and thus prevents the activation of a single receptor RANKL - the nuclear factor activator ?B (RANK) located on the surface of osteoclasts and their predecessors. Thus, preventing the interaction of RANKL / RANK inhibits the formation, activation and longevity of osteoclasts. As a result, denosumab reduces bone resorption and increases the mass and strength of the cortical and trabecular bone layers.

How should I use Prolia (Denosumab)?

Always follow your doctor`s instructions when using Prolia (Denosumab) to get the safest and most effective results from treatment. The recommended dose of Prolia (Denosumab) is one subcutaneous injection of 60 mg every 6 months. During the course of treatment it is recommended to take calcium supplements and vitamin D.

To avoid discomfort at the injection site, warm the solution to room temperature (up to 25�C) before injection, and then slowly inject the entire contents of the pre-filled syringe. The syringe with the remnants of the drug must be disposed. Detailed recommendations for self-injection of the drug are included in the instructions for medical use.

Do not shake the solution before administration.

Any amount of unused drug or unused materials must be disposed of in accordance with local requirements.

What are the side effects of Prolia (Denosumab)?

The use of Prolia (Denosumab) may cause side effects in some patients including:

• articular and muscle pain in the limbs
• eczema
• cataract
• hypocalcaemia
• atypical fracture of the hip bones
• allergic reactions

Please Note

There is no data on the use of the drug during pregnancy. Prolia (Denosumab) is not recommended for use in pregnant women.

Prolia (Denosumab) is not recommended for use in pediatrics, as the efficacy and safety of this drug has not been studied in this age group.

Based on the available data on the efficacy and safety of the drug in this age group, no adjustment of the dosage regimen of the drug is required.