Burosumab-Twza Injection (Crysvita)

Crysvita (burosumab‑twza) is covered only for the FDA‑approved indication X‑linked hypophosphatemia (XLH) and is not authorized for non‑FDA/off‑label uses. Initial approval (12 months) requires prescription by or consultation with an endocrinologist/nephrologist, baseline serum phosphorus below the age‑normal plus either a low TmP/GFR or a documented PHEX mutation obtained prior to any XLH treatment, dosing limits (≤90 mg SC; adults no more often than every 4 weeks, pediatrics no more often than every 2 weeks), and reauthorization (12 months) requires documentation of clinical benefit (e.g., increased phosphorus, radiographic improvement, or fewer/newly healed fractures).

"Crysvita is indicated for the treatment of X-linked hypophosphatemia (XLH)."

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