Recommended Dosing Regimen for Prolia (Denosumab) Injection
The recommended dose of Prolia (denosumab) is 60 mg administered as a single subcutaneous injection once every 6 months. 1
Administration Details
- Prolia should be administered by a healthcare professional via subcutaneous injection in the upper arm, upper thigh, or abdomen 1
- Prior to administration, Prolia may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container for 15-30 minutes 1
- Do not warm Prolia in any other way 1
- Visually inspect the solution for particulate matter and discoloration before administration - it should be clear, colorless to pale yellow 1
Important Pre-Administration Requirements
- Pregnancy testing must be performed in all females of reproductive potential prior to administration of Prolia 1
- For patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²), evaluate for chronic kidney disease mineral and bone disorder (CKD-MBD) with intact parathyroid hormone, serum calcium, and vitamin D levels 1
- All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily as supplementation 1
Clinical Efficacy
- Denosumab has demonstrated significant increases in bone mineral density (BMD) in postmenopausal women with osteoporosis 2
- In clinical studies, denosumab treatment resulted in BMD increases of 4.2% at 12 months, 7.5% at 24 months, and 8.8% at 36 months in the lumbar spine 2
- The ABCSG-18 trial showed that denosumab significantly delayed time to occurrence of clinical fractures (HR, 0.5; 95% CI, 0.39 to 0.65; P < .001) 3
Missed Doses
- If a dose of Prolia is missed, administer the injection as soon as the patient is available 1
- Thereafter, schedule injections every 6 months from the date of the last injection 1
Advantages of Denosumab
- The 6-month dosing interval may improve patient adherence compared to more frequently dosed medications 4, 5
- Denosumab does not require renal dose adjustment, which may be advantageous for patients with reduced kidney function 6
- Subcutaneous administration may be preferred by patients who have difficulty with oral medications 5, 7
Safety Considerations
- Monitor for hypocalcemia, which is a listed contraindication 3
- When denosumab is discontinued, there may be an increased risk of vertebral fractures 3
- The European Calcified Tissue Society suggests using a bisphosphonate when stopping denosumab to reduce fracture risk 3
Clinical Pearls
- Denosumab has a novel mechanism of action - it binds to receptor activator of nuclear factor κB ligand (RANKL) and inhibits bone resorption by inhibiting osteoclast formation, function, and survival 5
- The convenience of subcutaneous administration every 6 months may contribute to better compliance with treatment recommendations 2, 4
- Denosumab may be particularly useful for patients with gastrointestinal contraindications or side effects from oral bisphosphonates 7