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CRYSVITA
Bone disorders
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Drug Name:

CRYSVITA Rx

Generic Name and Formulations:
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.

Company:
Ultragenyx Pharmaceutical Inc.

Therapeutic Use:

RECENT UPDATES

Monograph added.

Indications for CRYSVITA:

Treatment of X-linked hypophosphatemia in patients aged ≥1 year.

Adult:

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).

Children:

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).

Contraindications:

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.

Warnings/Precautions:

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.

Pharmacological Class:

Fibroblast growth factor 23 (FGF23) blocking antibody.

Adverse Reactions:

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.

Generic Availability:

NO

How Supplied:

Single-dose vial—1

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