Leaflet PROLIA 60mg / ml solution for injection
Indicated for: osteoporosis
Route of administration: injectable
Substance: denosumab (monoclonal antibody)
ATC: M05BX04 (Musculo-skeletal system | Drugs affecting bone structure and mineralization | Other drugs affecting bone structure and mineralization)
Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.
This medicine is subject to additional monitoring.
Use during breastfeeding only on medical advice.
Use during pregnancy only on medical advice.
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.
General data about PROLIA 60mg / ml
- Substance: denosumab
- Date of latest medicines list: 01-07-2013
- Product code: W55640001
- Concentration: 60mg / ml
- Pharmaceutical form: solution for injection
- Quantity: 1
- Product type: Original
- Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.