Zoledronic Acid (Reclast) Injection

Zoledronic acid (Reclast) IV is covered only for FDA‑approved indications—treatment/prevention of postmenopausal osteoporosis, treatment of osteoporosis in men, glucocorticoid‑induced osteoporosis, and Paget's disease—and no off‑label compendial uses are covered. Approval requires safety labs (serum calcium > lab LLN, CrCl ≥35 mL/min, no acute renal impairment), indication‑specific risk thresholds (BMD T‑scores, FRAX or fragility fracture criteria), documentation of prior inadequate response/contraindication/intolerance to oral bisphosphonates unless a fragility fracture is present, specified dosing/frequency limits (eg, 5 mg IV yearly for osteoporosis treatment, 5 mg every 2 years for prevention, single 5 mg for initial Paget's), and authorization is limited to 12 months with retreatment for Paget’s only for relapse or failure to normalize alkaline phosphatase.

"Treatment of osteoporosis in postmenopausal women (FDA-approved)."