Prolia Administration Route
Prolia (denosumab) is administered subcutaneously (SUBQ), not intramuscularly (IM).
Administration Details
The FDA-approved dosing is 60 mg administered as a single subcutaneous injection once every 6 months. 1
Approved Injection Sites
The recommended subcutaneous injection sites include 1:
- Upper arm
- Upper thigh
- Abdomen
Critical Administration Instructions
- Do NOT administer into muscle or blood vessel - this is explicitly contraindicated in the FDA labeling 1
- The injection must be administered by a healthcare professional 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 to 30 minutes 1
- Do not warm Prolia in any other way 1
Clinical Trial Evidence Confirming Subcutaneous Route
Multiple large-scale clinical trials consistently used the subcutaneous route 2:
- ABCSG-18 trial: Patients received subcutaneous denosumab 60 mg every 6 months 2
- D-CARE trial: Denosumab 120 mg was administered subcutaneously 2
- FREEDOM trial: The pivotal trial establishing denosumab efficacy used subcutaneous administration 3
Comparison with Other Bone-Modifying Agents
For context, other bone-modifying agents have different routes 2:
- Calcitonin-salmon (Miacalcin): Can be given SC or IM every other day 2
- Teriparatide (Forteo): 20 mcg SC per day 2
- Zoledronic acid (Reclast): IV administration 2
The subcutaneous route for Prolia is non-negotiable and supported by all regulatory approvals, clinical guidelines, and research evidence.