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The use of the active ingredient is reserved for adult patients only; it is administered parenterally and, more precisely, subcutaneously. Currently, in Italy there are two denosumab-based medicines with trade names Xgeva® (indicated in the presence of bone metastases and giant cell tumor of bone) and Prolia® (indicated in the treatment of osteoporosis). Both classified as class A drugs, therefore reimbursable by the National Health System (NHS), these drugs can be dispensed on prescription medical repeatable limitative (RRL - sold to the public on prescription from hospitals or specialists).
. In detail, at the right dosage, the active ingredient can be used for:
- Treat osteoporosis in postmenopausal women and adult male patients to reduce the risk of fractures;
- Treating bone loss in men caused by a reduction in hormone (testosterone) levels due to surgery or drug therapy for prostate cancer;
- Treat bone loss due to long-term corticosteroid treatment in patients at increased risk of fractures;
- Reduce bone degradation caused by bone metastases or due to giant cell tumor of bone;
- Preventing serious complications caused by bone metastases (for example, fractures, pressure on the bone marrow, or the need for radiation therapy or surgery).
Denosumab can also be used to treat giant cell cancer of bone that cannot be treated surgically or where surgery is not the best option, in adults and adolescents whose bones have stopped growing.
;Hypocalcemia
If symptoms such as twitching, twitching or muscle cramps, numbness or tingling in the fingers and toes or around the mouth, seizures, confusion and / or loss of consciousness occur during treatment with denosumab, the doctor should be alerted immediately, as they may be symptoms of hypocalcemia.
Tooth problems and osteonecrosis of the jaw
Treatment with denosumab can lead to dental problems and osteonecrosis of the jaw. To prevent the onset of these problems it is useful to maintain correct oral hygiene and to undergo regular dental check-ups. In this regard, please note that the dentist must be informed of denosumab intake.
The risk of developing such conditions increases when treatment is continued for long periods and in patients who:
- Are undergoing chemotherapy and / or radiotherapy;
- Are taking steroids or anti-angiogenic medicines (used to treat cancer);
- They are undergoing dental surgery;
- They do not receive routine dental care;
- Suffering from gum problems;
- They are smokers.
If mouth or tooth problems such as falling teeth, pain or swelling, non-healing of mouth sores or discharge occur during denosumab therapy, you should contact your doctor immediately.
Unusual fractures
Some patients have experienced unusual fractures of the femur while taking denosumab. Therefore, in the event of a new and unusual pain in the hip, groin or thigh, a doctor should be contacted immediately.
Increased blood calcium
After stopping denosumab treatment, some patients with giant cell cancer of bone have experienced increased blood levels of calcium. The doctor will therefore monitor patients even after stopping denosumab treatment in order to quickly identify any increase in calcium.