DENOSUMAB INJ,SOLN
Clinical Criteria Summary
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Exclusion Criteria
- Hypocalcemia or pre-existing disturbance of mineral metabolism not effectively corrected or treated
- Documentation of need for invasive dental procedure (e.g., tooth extraction, dental implant, dental infection treatment) or recent unhealed procedure
- Acute dental issue identified by history or clinician mouth examination
- Receiving denosumab (XGEVA)
- Pregnancy or lactating
- Exception: Patients with secondary or tertiary hyperparathyroidism due to chronic kidney disease and low bone mineral density who are nonsurgical candidates
- Inclusion Criteria (All must be met)
- Diagnosis of osteoporosis or at risk for glucocorticoid-induced osteoporosis
- Prescriber is a VA/VA Community Care endocrinologist, rheumatologist, nephrologist, geriatrician, or locally designated expert
- Patient’s total daily dietary and supplemental calcium intake is 1000 to 1200 mg/day
- 25-hydroxyvitamin D concentration >30 ng/mL or > 20 ng/ml with appropriate intake (e.g., cholecalciferol >800 international units per day)
- Prescriber has documented discussion of severe hypocalcemia risk and need for close monitoring if eGFR < 30ml/min
- For patients with eGFR < 35 ml/min, risks and benefits of indefinite denosumab discussed due to inability to transition to bisphosphonates
- Requirement to transition to another antiresorptive agent upon discontinuation to prevent rebound fractures
- Additional Criteria (One of the following must be met)
- Allergy, contraindication, unsatisfactory response, or intolerable adverse events with bisphosphonate therapy
- Osteoporotic fracture and T-score at hip or spine < -2.5
- Very high fracture probability by Fracture Risk Assessment Tool (FRAX) (e.g., major osteoporosis fracture >30%, hip fracture >4.5%)
- T-score < -3.0
- More than 2 osteoporotic fractures
- Continued bone mineral density loss or sustained osteoporotic fracture while on other approved osteoporosis therapy
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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