Treatment of osteoporosis in postmenopausal women and men with an increased risk of fractures. In postmenopausal women, Prolia significantly reduces the risk of vertebral fractures, non- spinal fractures, and hip fractures. Treatment of bone loss in men with an increased risk of vertebral fractures who receive hormone-suppressive therapy for prostate cancer. In men with prostate cancer receiving hormone- suppressive therapy, Prolia significantly reduces the risk of vertebral fractures.
The main active ingredients of the drug are denosumab.
The auxiliary substances are: sorbitol, glacial acetic acid, sodium hydroxide, polysorbate, water for injection.
It is produced in the form of a solution for injection.
One 1 ml pre-filled syringe with a needle protector containing 60 mg denosumab.
This medicinal product Prolia belongs to the drugs used for the treatment of bone diseases and other drugs that affect the structure and mineralization of bones.
The properties of the drug are based on the mechanism of action of its main active ingredient – denosumab.
It is an antibody (human monoclonal) that has a high affinity and specificity for the ligand of the nuclear factor activator receptor. Due to biochemical processes, it is able to inhibit the formation, activation and duration of the existence of osteoclasts. As a result, bone resorption decreases and the mass and strength of the cortical and trabecular bone layers increases.
In postmenopausal women suffering from osteoporosis, denosumab causes an increase in bone mineral density, reducing the number of hip fractures, as well as fractures of other bones of the skeleton.
This drug Prolia is used to prevent pathological changes in bones, in particular for treatment;
- osteoporosis in women during menopause;
- bone loss in women receiving aromatase inhibitor therapy for breast cancer and in men with prostate cancer receiving hormone-deprivation therapy.
Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Also does not apply if the person has hypocalcemia.
It is not used in pediatrics, since its effect on persons under 18 years of age has not been studied.
Application during pregnancy and lactation
It is contraindicated to use for the treatment of pregnant or lactating women.
If there is a need for use during lactation, then breastfeeding for this time should be canceled.
Method of administration and dosage
This Prolia product is intended for subcutaneous administration. The introduction is made in the thigh or abdomen, using the area around the navel.
The entire contents of the vial are introduced completely after preliminary training.
Recommendations for the route of administration are detailed in the attached instructions. It is also advisable to pre-consult on the method of administration of the drug with the attending physician.
To avoid discomfort during administration, the drug is pre-heated to room temperature.
The recommended dosage is one subcutaneous injection of 60 mg (1 ml of the drug) every 6 months.
Regular daily supplementation of calcium and vitamin D supplements is required (except in cases of hypercalcemia).
Elderly people and those with renal and / or hepatic impairment do not require dose adjustment.
Overdose of the specified drug was not observed.
Therapy with this drug, in case of manifestations of a hypersensitivity reaction, can cause allergic reactions in the form of:
- musculoskeletal pain;
- osteonecrosis of the jaw (sometimes seen in people with advanced cancer).
If you have any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.
Storage conditions and periods
The shelf life of the drug is no more than 3 years from the production date indicated on the package.
Store Prolia in a dry place out of the reach of children, at temperatures between 2 ° C and 8 ° C.
After removal from the refrigerator, it can be stored for no more than 30 days at a temperature not exceeding 25 ° C.
Do not freeze!