PROLIA 60mg / ml solution for injection medication leaflet

M05BX04 • denosumab • Musculo-skeletal system | Drugs affecting bone structure and mineralization | Other drugs affecting bone structure and mineralization

Denosumab is a monoclonal antibody used for the treatment of osteoporosis in patients at high risk of fractures, as well as for managing bone loss associated with cancer treatments. It works by inhibiting RANKL, a protein involved in bone resorption, thereby reducing bone mass loss.

The medication is administered via subcutaneous injection, usually once every six months, and treatment requires supplementation with calcium and vitamin D. Common side effects include back pain, muscle pain, hypocalcemia, and urinary tract infections.

Denosumab is contraindicated in patients with untreated hypocalcemia or hypersensitivity to the active substance. Its use also requires careful monitoring to prevent complications such as atypical fractures or osteonecrosis of the jaw.

This medication is an important option for patients with osteoporosis or bone loss, helping to reduce fracture risk and improve their quality of life.