When to Prescribe Prolia (Denosumab)
Prolia (denosumab) is indicated for patients with osteoporosis at high risk for fracture, patients with cancer-related bone metastases, and those experiencing cancer treatment-induced bone loss. The decision to prescribe Prolia should be based on specific clinical scenarios where its benefits outweigh potential risks.
Indications for Prolia in Osteoporosis
Postmenopausal Women with Osteoporosis
- For postmenopausal women with osteoporosis at high risk for fracture 1
- When patients cannot use or have failed other osteoporosis medications 1
- For patients with T-scores ≤ -2.5 SD who need significant BMD improvement 2
Men with Osteoporosis
- To increase bone mass in men with osteoporosis at high risk for fracture 1
- When other therapies have failed or are contraindicated 1
Glucocorticoid-Induced Osteoporosis
- For men and women at high risk for fracture who will be taking corticosteroid medicines for at least 6 months 1
Cancer-Related Indications
Cancer Treatment-Induced Bone Loss
- For women receiving adjuvant aromatase inhibitor therapy for breast cancer who are at high risk for fracture 1
- For men receiving androgen deprivation therapy for nonmetastatic prostate cancer who are at high risk for fracture 1
Bone Metastases
- For breast cancer patients with bone metastases, whether symptomatic or not 3
- For patients with castration-resistant prostate cancer (CRPC) and bone metastases 3
- For patients with advanced lung cancer, renal cancer, and other solid tumors with clinically significant bone metastases and life expectancy of at least 3 months 3
- For multiple myeloma patients at diagnosis 3
- Preferred in multiple myeloma patients with renal impairment (creatinine clearance <60 ml/min) 3
Special Considerations for Prescribing
Dosing Schedule
- Administer 60 mg subcutaneously every 6 months 1
- For cancer patients with bone metastases, administer every 4 weeks; extending intervals beyond this frequency is not recommended 3
Pre-Treatment Requirements
- Rule out pregnancy before administration 1
- Complete dental evaluation and necessary invasive dental treatments before initiating therapy 3, 1
- Correct vitamin D deficiency and ensure adequate calcium intake 3, 1
- For patients with advanced chronic kidney disease, evaluate for chronic kidney disease-mineral bone disorder with intact parathyroid hormone, serum calcium, and vitamin D levels 1
Monitoring
- Monitor serum calcium levels, especially in patients with renal impairment 1
- Regular dental examinations to minimize risk of osteonecrosis of the jaw 1
- Monitor for signs of infection, including cellulitis 1
Contraindications and Cautions
Contraindicated in:
Use with caution in:
Transitioning Between Therapies
- When discontinuing denosumab after more than 6 months, consider bisphosphonate treatment (e.g., zoledronic acid) to suppress rebound osteolysis 3
- Patients should not receive both Prolia and Xgeva (higher-dose denosumab used for prevention of skeletal-related events in patients with bone metastases) 1
Duration of Treatment
- For osteoporosis: typically recommended for up to 5 years, with consideration of benefits versus risks for longer treatment 4
- For cancer-related bone metastases: continue throughout the course of disease 3
- For multiple myeloma: may be interrupted after 2 years in patients in remission 3
Important Safety Considerations
- Risk of osteonecrosis of the jaw increases with long-term use (>5 years) 4
- Multiple vertebral fractures may occur following discontinuation; patients should be transitioned to another antiresorptive agent if Prolia is discontinued 1
- Severe hypocalcemia can occur, especially in patients with advanced kidney disease 1
- Dermatologic reactions including rash and eczema have been reported 1
By following these guidelines, clinicians can appropriately prescribe Prolia to patients who will benefit most while minimizing potential risks.