DENOSUMAB-BMWO INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Hypocalcemia (corrected calcium at or below lower limit of normal) that has not been effectively corrected
- Documentation of the need for an invasive dental procedure (e.g., tooth extraction, dental implant, and/or dental infection treatment) or recent procedure that has not fully healed
- Acute dental issue identified by history or clinician mouth examination
- Receiving denosumab (PROLIA), zoledronic acid, or pamidronate
- Pregnancy
Inclusion Criteria (Cancer-Related Indications)
- Prevention of skeletal-related events in patients with multiple myeloma refractory or intolerant to zoledronic acid (or if zoledronic acid contraindicated based on renal function)
- Prevention of skeletal-related events in patients with bone metastases from solid tumors refractory or intolerant to zoledronic acid (or if zoledronic acid contraindicated based on renal function)
- Treatment of unresectable giant cell tumor of the bone
- Treatment of hypercalcemia of malignancy refractory to zoledronic acid therapy (or if zoledronic acid contraindicated based on renal function)
Additional Inclusion Criteria
- Prescriber must be a VA/VA Community Care hematologist, oncologist, urologist, hospitalist, or endocrinologist
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 5 months after stopping treatment
Dosing & Safety Considerations
- Dose: 120 mg subcutaneous every 4 weeks (do not confuse with denosumab Prolia)
- Patients with an eGFR <30 ml/minute are at increased risk of hypocalcemia