Zoledronic Acid (Reclast®) Injection

Evicore authorizes zoledronic acid (Reclast) for FDA‑approved indications — treatment and prevention of postmenopausal osteoporosis, treatment of osteoporosis in men, treatment/prevention of glucocorticoid‑induced osteoporosis, Paget’s disease — and for compendial off‑label use in osteogenesis imperfecta, and excludes non‑FDA/non‑compendial uses. Approval requires diagnostic criteria (osteoporotic/fragility fracture or T‑score ≤ −2.5, or low bone mass with high fracture risk), usually a documented 12‑month oral bisphosphonate trial unless there is a fracture or documented intolerance/inability to take oral bisphosphonates, adherence to dosing limits (5 mg IV yearly for treatment, every 2 years for prevention, single dose for Paget’s, OI dosing up to 0.05 mg/kg no more often than q3 months), and reauthorization documentation showing stability, fewer vertebral fractures or increased BMD (plus ≥24 months since last dose for prevention).

"Treatment and prevention of osteoporosis in postmenopausal women"