From the Guidelines
Prolia (denosumab) should be administered as a 60 mg subcutaneous injection once every 6 months. This dosing regimen is consistent across most indications, including postmenopausal osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer, and bone loss in women receiving aromatase inhibitors for breast cancer, as supported by the most recent evidence from 1. To administer Prolia, draw the entire contents of the pre-filled syringe (60 mg in 1 mL) and inject it subcutaneously into the upper arm, upper thigh, or abdomen. It's crucial to rotate injection sites with each administration to prevent injection site reactions. Patients should also take calcium and vitamin D supplements while on Prolia therapy, with a typical recommendation of 1000 mg of calcium and 400-800 IU of vitamin D daily, but specific amounts may vary based on individual needs and should be determined by a healthcare provider, as suggested by 1 and 1. Key points to consider when administering Prolia include:
- The 6-month dosing interval is based on the drug's long half-life and sustained effect on bone turnover markers.
- Prolia works by inhibiting RANK ligand, which reduces bone resorption and increases bone density.
- This infrequent dosing schedule can improve patient adherence compared to daily or weekly osteoporosis medications. The strongest evidence of benefit from antiresorptive drugs is for treatment with denosumab at the osteoporosis dose of 60 mg every 6 months, as demonstrated in 1, which has been shown to reduce the risk of fracture.
From the FDA Drug Label
2.3 Recommended Dosage Prolia should be administered by a healthcare professional. The recommended dose of Prolia is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.1)]. If a dose of Prolia is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection.
The dosing for Prolia (denosumab) is 60 mg administered as a single subcutaneous injection once every 6 months. Key points to consider:
- The injection should be administered by a healthcare professional.
- The recommended injection sites include the upper arm, upper thigh, or abdomen.
- Patients should also receive calcium 1000 mg daily and at least 400 IU vitamin D daily.
- If a dose is missed, it should be administered as soon as possible, and then scheduled every 6 months from the date of the last injection 2.
From the Research
Dosing for Prolia (Denosumab)
The dosing for Prolia (denosumab) is as follows:
- 60 mg administered via subcutaneous injection every 6 months 3, 4
- The injection can be administered in the upper arm, upper thigh, or abdomen 4
Administration and Adherence
The subcutaneous injection method of administration may improve adherence to treatment compared to other osteoporosis treatments 3, 5
- Patients have shown a preference for the 6-month injection regimen over weekly oral tablets 6
- The convenience of the administration scheme and route may contribute to strict compliance with doctor's recommendations 7
Clinical Evidence
Clinical trials have demonstrated the efficacy and safety of denosumab in increasing bone mineral density and reducing the risk of fractures in postmenopausal women with osteoporosis 3, 4, 7
- Denosumab has been shown to be effective in increasing bone mineral density in both treated and untreated patients 7