How Prolia (Denosumab) is Administered
Prolia is administered as a 60 mg subcutaneous injection once every 6 months by a healthcare professional, injected into the upper arm, upper thigh, or abdomen. 1
Pre-Treatment Requirements
Before initiating Prolia, specific assessments must be completed:
- Pregnancy testing is mandatory in all females of reproductive potential prior to each administration, as denosumab can cause fetal harm 1
- Dental examination is recommended before starting therapy to minimize the risk of osteonecrosis of the jaw 2
- In patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²) or dialysis-dependent patients, evaluate for chronic kidney disease mineral and bone disorder (CKD-MBD) by measuring intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25(OH)₂ vitamin D before treatment decisions 1
- Pre-existing hypocalcemia must be corrected before initiating Prolia, as this is a contraindication to treatment 1
Dosing Schedule and Administration Technique
- Standard dose: 60 mg every 6 months for osteoporosis indications 1, 3
- Higher dose for bone metastases: 120 mg monthly subcutaneously (different indication than osteoporosis) 4, 2
- For giant cell tumors of bone: Monthly subcutaneous injection after three loading doses at weekly intervals 4
Injection Sites
The injection can be administered in three locations 1:
- Upper arm
- Upper thigh
- Abdomen
Missed Dose Protocol
If a dose is missed, administer the injection as soon as the patient is available, then schedule subsequent injections every 6 months from the date of that last injection 1
Mandatory Supplementation
All patients must receive calcium and vitamin D supplementation throughout treatment 1:
- Calcium: 1,000 mg daily (some guidelines recommend 1,200-1,500 mg daily) 4, 2, 1
- Vitamin D: At least 400 IU daily (some guidelines recommend 400-800 IU or up to 1,000-2,000 IU daily) 4, 5, 2, 1
The FDA label specifically states that vitamin D deficiency should be corrected before starting denosumab treatment 6
Preparation Instructions
- Remove from refrigerator and allow to reach room temperature (up to 25°C/77°F) by standing in the original container for 15-30 minutes 1
- Do not warm in any other way 1
- Inspect visually for particulate matter and discoloration—the solution should be clear, colorless to pale yellow and may contain trace amounts of translucent to white proteinaceous particles 1
- Do not use if the solution is discolored, cloudy, or contains many particles or foreign particulate matter 1
Safety Guard Activation (Prefilled Syringe)
The prefilled syringe has a green safety guard that must be handled correctly 1:
- Do NOT slide the green safety guard forward over the needle before injection—it will lock in place and prevent injection 1
- After injection is complete, immediately slide the green safety guard over the needle until it locks securely in place with an audible "click" 1
- Do NOT put the gray needle cap back on the used needle 1
- Immediately dispose of the syringe and needle cap in the nearest sharps container 1
Critical Monitoring Considerations
- Serum calcium monitoring is essential, especially in patients with renal impairment, as severe hypocalcemia can occur and has resulted in hospitalization and fatal cases 1
- Patients with advanced chronic kidney disease are at markedly greater risk of severe hypocalcemia and should be supervised by a healthcare provider with expertise in CKD-MBD management 1
- Concomitant use of calcimimetic drugs may worsen hypocalcemia risk 1
Important Contraindications
Prolia is contraindicated in 1:
- Patients with hypocalcemia (must be corrected before initiating therapy)
- Pregnant women
- Patients with known hypersensitivity to denosumab
Administration by Healthcare Professional
Prolia must be administered by a healthcare professional—it is not for self-injection by patients 1. This differs from some other osteoporosis medications and ensures proper technique and immediate management of any adverse reactions.