What is the proper administration and dosage of Prolia (denosumab)?

How to Use Prolia (Denosumab)

The recommended dose of Prolia (denosumab) is 60 mg administered as a single subcutaneous injection once every 6 months in the upper arm, upper thigh, or abdomen, and should be administered by a healthcare professional. 1

Pre-Administration Requirements

• Pregnancy must be ruled out prior to administration of Prolia by performing pregnancy testing in all females of reproductive potential 1
• For patients with advanced chronic kidney disease (eGFR < 30 mL/min/1.73 m²), evaluate for chronic kidney disease mineral and bone disorder with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25(OH)₂ vitamin D 1
• Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia 1
• A baseline dental examination is recommended before starting treatment to reduce the risk of osteonecrosis of the jaw 2

Administration Technique

1. Preparation:

   • Visually inspect the solution for particulate matter and discoloration 1
   • Prolia should appear as a clear, colorless to pale yellow solution 1
   • Allow Prolia to reach room temperature (up to 25°C/77°F) by standing in the original container for 15-30 minutes 1

2. Injection Procedure:

   • Remove the gray needle cap 1
   • Choose an injection site: upper arm, upper thigh, or abdomen 1
   • Insert needle and inject all liquid subcutaneously (not into muscle or blood vessel) 1
   • After injection, activate the green safety guard by sliding it over the needle until it locks securely in place 1
   • Dispose of the syringe and needle cap in a sharps container 1

Required Supplementation

• All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily during treatment 1
• Regular monitoring of serum calcium levels is necessary, especially after the first few doses 2

Missed Dose Management

• If a dose 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

Monitoring During Treatment

• Monitor serum calcium before each denosumab injection 2
• Evaluate vitamin D status intermittently during treatment 2
• Monitor oral health throughout treatment to detect early signs of osteonecrosis of the jaw 2

Common Side Effects and Management

• Most common adverse effects include arthralgia, nasopharyngitis, headache, and back pain 3, 4
• Hypocalcemia is more common with denosumab (13%) than with zoledronic acid (6%) 2, 5
• Osteonecrosis of the jaw occurs at low rates but requires monitoring 3, 2

Patient Preference Considerations

• Studies show that patients generally prefer the 6-month subcutaneous injection regimen over weekly oral tablets for osteoporosis treatment 6
• The convenience of the 6-month dosing schedule may improve adherence compared to more frequent dosing regimens 7, 8

Special Considerations

• Unlike bisphosphonates, denosumab does not require dose adjustment for renal impairment 2
• When denosumab is discontinued, there may be an increased risk of vertebral fractures, and using a bisphosphonate may reduce this risk 9
• Avoid invasive dental procedures when possible during treatment 2