Generic Name and Formulations:
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.
Ultragenyx Pharmaceutical Inc.
Indications for CRYSVITA:
Treatment of X-linked hypophosphatemia in patients aged ≥1 year.
Discontinue oral phosphate and active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. ≥18yrs: 1mg/kg every 4 weeks; max 90mg. Assess fasting serum phosphorus every 4 weeks, measured 2 weeks post-dose, for the first 3 months, 2 weeks after a dose adjustment, then thereafter as needed. Interrupt or reduce dose based on serum phosphorus level; do not adjust sooner than every 4 weeks (see full labeling).
<1yr: not established. Discontinue oral phosphate and active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. 1–<18yrs: initially 0.8mg/kg every 2 weeks; max 90mg. Assess fasting serum phosphorus every 4 weeks for the first 3 months, 4 weeks after a dose adjustment, then thereafter as needed. Adjust dose based on serum phosphorus level, but not sooner than every 4 weeks (see full labeling).
Concomitant oral phosphate and active vitamin D analogs. Serum phosphorus within or above normal range for age: do not initiate. Severe renal impairment or ESRD.
Prior to initiation, confirm fasting serum phosphorus concentration below reference range for age. Discontinue if serious hypersensitivity or severe inj site reactions occur. Elderly. Pregnancy. Nursing mothers.
Fibroblast growth factor 23 (FGF23) blocking antibody.
Headache, inj site reaction, vomiting, pyrexia, extremity pain, vitamin D decreased, back pain, tooth infection, restless leg syndrome, dizziness, constipation, blood phosphorus increased; hypersensitivity, hyperphosphatemia, nephrocalcinosis.
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