Administer once every two weeks by subcutaneous injection¹

Dosing in patients 6 months to 1 year and adolescents (aged 13 to 17) was derived using modelling and simulation of adult and pediatric (aged 1 to 12 years) PK and PD data.

CRYSVITA is administered by subcutaneous injection and should be administered by a health professional.

For patients aged 6 months to <1 year (with body weight ≥6 kg):

RECOMMENDED STARTING DOSE:
0.8 mg/kg of body weight
Round down to the nearest 1 mg Minimum recommended initial dose: 5 mg

For patients aged 1 to 18 years:

RECOMMENDED STARTING DOSE:
0.8 mg/kg of body weight
Round to the nearest 10 mg Minimum recommended starting dose: 10 mg, up to a maximum dose of 90 mg

Check patient weight periodically to ensure proper total dose for patient weight is being administered.

Monitoring for dose adjustments:

Measure fasting serum phosphorus every 4 weeks for the first 3 months of treatment, and thereafter as appropriate.

Dose calculator for pediatric patients with XLH

Use the dosing calculator to determine your pediatric patients’ dose and the vials needed.

Select patient age

6 months to <1 year

1 to 18 years

Enter patient weight (kg)

Dose:

X mg every 2 weeks

Vials needed (mg/mL):

Dose adjustments for pediatric patients with XLH

If serum phosphorus is within the lower limit of the reference range for age:

Continue treatment with the same dose.

If serum phosphorus is below the reference range for age:

Increase dose stepwise in intervals of 0.4 mg/kg.

Maximum in patients aged 6 months to <1 year: 1.2 mg/kg

The calculated dose should be rounded to the nearest 1 mg.

Maximum in patients aged 6 months to <1 year: 1.2 mg/kg

Maximum in patients aged 1 to 18 years: 2 mg/kg

The calculated dose should be rounded to the nearest 10 mg with a maximum dose of 90 mg.

Reassess fasting serum phosphorus level 4 weeks after dose adjustment. Do not adjust CRYSVITA dose more frequently than every 4 weeks.

If serum phosphorus is above the reference range for age:

Withhold the next dose and reassess the serum phosphorus level in 4 weeks. The patient must have serum phosphorus below the reference range for age to reinitiate CRYSVITA.

Once serum phosphorus is below the reference range for age, restart CRYSVITA at half the dose level previously administered.

Gradually increase the dose according to the instructions above if the level is below the reference range for age upon reassessment 4 weeks later.

See CRYSVITA Product Monograph for complete dosing and administration instructions.

Administration of CRYSVITA

CRYSVITA is administered by subcutaneous injection and should be administered by a health professional based on the patient’s age and body weight.¹

If a given dose requires multiple vials of CRYSVITA, contents from two vials can be combined for injection (the maximum volume per injection is 1.5 mL).¹

If multiple injections are required, administer at different injection sites.

CRYSVITA comes in 3 strengths¹

Not actual size.

Injection sites should be rotated with each injection administered at a different anatomic location than the previous injection. Injection sites include:¹

Upper arms
Upper thighs
Buttocks
Any quadrant of the abdomen

Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

See CRYSVITA Product Monograph for complete dosing and administration instructions.

PD=pharmacodynamic; PK=pharmacokinetic.

Reference: 1. CRYSVITA (burosumab injection) Product Monograph. Kyowa Kirin Inc. March 15, 2023.

Administer once every two weeks by subcutaneous injection1

Administer once every two weeks by subcutaneous injection¹