TM Owner Amgen
Prolia 60mg/ml Injection
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Indications & Clinical Uses
- Prolia (denosumab) 60 mg/mL is a monoclonal antibody that blocks RANKL, a protein involved in bone breakdown, given as a single subcutaneous injection once every 6 months by a healthcare provider.
- It is approved to treat osteoporosis in postmenopausal women at high risk of fracture, to increase bone mass in men with osteoporosis at high risk of fracture, to treat glucocorticoid-induced osteoporosis in men and women at high fracture risk, and to increase bone mass in patients at high fracture risk receiving certain hormone-deprivation therapy for breast or prostate cancer.
- Prolia (60 mg) must not be confused with Xgeva, a different denosumab product given at a 120 mg dose for cancer-related bone complications; the two are not interchangeable and mixing them up is a recognised medication-safety risk.
Side Effects
- Prolia carries a boxed warning, added in 2024, for a higher risk of severe hypocalcemia (very low blood calcium) in patients with advanced chronic kidney disease, including those on dialysis, which has led to hospitalisation and fatal cases; calcium levels must be checked and corrected before treatment and monitored closely afterward in this group.
- Very commonly reported side effects include back pain, pain in the arms or legs, muscle and bone pain, raised cholesterol, and bladder or urinary tract infections.
- Other serious risks include osteonecrosis of the jaw, unusual (atypical) thigh-bone fractures, and multiple spinal fractures that can occur after stopping the medicine.
- Report jaw pain, unusual thigh or groin pain, muscle spasms, numbness or tingling (possible signs of low calcium), or any new dental problem to your healthcare provider promptly.
Precautions & Warnings
- Existing low calcium must be corrected before starting Prolia, and all patients should take adequate calcium (at least 1000 mg daily) and vitamin D (at least 400 IU daily) throughout treatment; calcium levels are monitored more closely in people with kidney problems, especially advanced chronic kidney disease, because of the boxed warning for severe hypocalcemia.
- A dental check-up is recommended before starting, and invasive dental work should be avoided during treatment where possible, because of the risk of osteonecrosis of the jaw; report any unusual thigh, hip, or groin pain, which can be an early sign of an atypical femur fracture.
- Prolia should not be stopped or delayed without discussing a follow-on treatment plan with your prescriber, since spinal fracture risk can rise after stopping.
- It should not be used in pregnancy, as it may harm the unborn baby, and effective contraception is recommended during treatment and for several months after the last dose.
- Serious infections, including skin infections such as cellulitis, have been reported.
Avoid Interactions
- Prolia should not be given together with, or interchanged with, other denosumab-containing products such as Xgeva, because the two are dosed differently for different conditions and mixing them up can cause serious harm.
- Caution is needed when Prolia is combined with corticosteroids or other immunosuppressant medicines, as both can add to the risk of serious infection, and with other bone-active medicines, since combining bone-targeted therapies is not routinely recommended.
- There are no major CYP-enzyme-based drug interactions described for denosumab, but you should still tell your healthcare provider and pharmacist about every other medicine, including other osteoporosis or bone treatments, calcium or vitamin D supplements, and any recent or planned dental work, before each injection.
References
Frequently Asked Questions
Prolia (denosumab) treats osteoporosis in postmenopausal women and in men at high fracture risk, including glucocorticoid-induced osteoporosis, and helps protect bone in some cancer patients on hormone-deprivation therapy. It's given as an injection every 6 months by a healthcare provider.
Prolia is a subcutaneous injection given once every 6 months by a doctor or nurse, along with daily calcium and vitamin D supplements. It is not a medicine you inject yourself at home.
Prolia has a boxed warning, added in 2024, for severe hypocalcemia (very low blood calcium) in people with advanced chronic kidney disease, including dialysis patients, which has caused hospitalisation and death. Calcium is checked and corrected before and during treatment in this group.
Avoid invasive dental work without telling your dentist you're on Prolia, due to a jaw bone risk, and don't confuse it with Xgeva, a different-dose denosumab product for cancer bone problems. Report new thigh or groin pain promptly.
Prolia lowers blood calcium as part of how it works, and this drop can be severe, especially with kidney disease. Your provider checks calcium before each dose and may test it more often if you have advanced kidney disease.
No. Stopping Prolia without a follow-on treatment plan raises the risk of multiple spinal fractures. Always discuss stopping or switching osteoporosis treatment with your prescriber before missing or delaying a dose.
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