HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CRYSVITA safely and effectively. See full prescribing information for CRYSVITA.
CRYSVITA ® (burosumab- twza ) injection, for subcutaneous use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older. (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only (2)
Pediatric XLH: Starting dose regimen is 0.8 mg/kg of body weight rounded to the nearest 10 mg, administered every two weeks. The minimum starting dose is 10 mg up to a maximum dose of 90 mg. (2.1)
Dose may be increased up to approximately 2 mg/kg (maximum 90 mg), administered every two weeks to achieve normal serum phosphorus. (2.1)
Adult XLH: Dose regimen is 1 mg/kg body weight rounded to the nearest 10 mg up to a maximum dose of 90 mg administered every four weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL, 20 mg/mL, or 30 mg/mL in a single-dose vial (3)
CONTRAINDICATIONS
Do not use CRYSVITA with oral phosphate and active vitamin D analogs. (4)
Do not initiate CRYSVITA if serum phosphorus is within or above the normal range for age. (4)
CRYSVITA is contraindicated in patients with severe renal impairment or end stage renal disease. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment. (5.1)
Hyperphosphatemia and Risk of Nephrocalcinosis: For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient’s serum phosphorus levels. (5.2)
Injection Site Reactions: Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment. (5.3, 6.1)
ADVERSE REACTIONS
Most common adverse reactions (≥25%) in pediatric XLH patients are: headache, injection site reaction, vomiting, pyrexia, pain in extremity, vitamin D decreased. (6.1)
Most common adverse reactions (≥5% and in at least 2 patients more than placebo) in adult XLH patients are: back pain, headache, tooth infection, restless leg syndrome, vitamin D decreased, dizziness, constipation, blood phosphorus increased. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Ultragenyx at 1-800-756-8657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 4/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1       INDICATIONS AND USAGE
2       DOSAGE AND ADMINISTRATION
2.1       Pediatric Patients with X-linked Hypophosphatemia (1 to less than 18 years of age)
2.2       Adult Patients with X-linked Hypophosphatemia (18 years of age and older)
2.3       Missed Dose
2.4       General Considerations for Subcutaneous Administration
3       DOSAGE FORMS AND STRENGTHS
4       CONTRAINDICATIONS
5       WARNINGS AN