Generic Name and Formulations:
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.
Ultragenyx Pharmaceutical Inc.
RECENT UPDATESMonograph added.
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 phosphorous 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 phosphorous level; do not adjust sooner than every 4 weeks (see full labeling).
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. <1yr: not established. 1–<18yrs: initially 0.8mg/kg every 2 weeks; max 90mg. Assess fasting serum phosphorous every 4 weeks for the first 3 months, 4 weeks after a dose adjustment, then thereafter as needed. Adjust dose based on serum phosphorous level, but not sooner than every 4 weeks (see full labeling).
Concomitant oral phosphate and active vitamin D analogs. Serum phosphorous within or above normal range for age: do not initiate. Severe renal impairment or ESRD.
Prior to initiation, confirm fasting serum phosphorous 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 phosphorous increased; hypersensitivity, hyperphosphatemia, nephrocalcinosis.
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