Please refer to the Summary of Product Characteristics for full details before prescribing.
CRYSVITA is dosed every 2 weeks in paediatric patients1
CRYSVITA is indicated for the treatment of XLH with radiographic evidence of bone disease in children aged ≥1 year and adolescents with growing skeletons.1
Dosing in children and adolescents is every 2 weeks.
The recommended starting dose is 0.8 mg/kg of body weight. All doses should be rounded to the nearest 10 mg. The maximum dose is 90 mg.
After initiating CRYSVITA, measure fasting serum phosphate:
- every 2 weeks for the first month of treatment
- every 4 weeks for the following 2 months
- thereafter as appropriate.
If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
It is recommended that fasting serum phosphate is targeted to the lower end of the normal reference range for age.
Oral phosphate and active vitamin D analogues (e.g. calcitriol) should be discontinued 1 week prior to initiation of treatment. Vitamin D replacement or supplementation (with inactive forms) may be started or continued as per local guidelines under monitoring of serum calcium and phosphate.
Calculation for starting dose
If fasting serum phosphate is below the reference range for age, the dose may be increased stepwise by 0.4 mg/ kg up to a maximum dose of 2 mg/kg (maximum dose of 90 mg).
Reassess fasting serum phosphate level 4 weeks after each dose adjustment.
If fasting serum phosphate is above the reference range for age, withhold the next dose and reassess fasting serum phosphate within 4 weeks.
Fasting serum phosphate must be below the reference range for age to restart CRYSVITA at approximately half of the previous dose, rounding the amount as described above.
Reassess fasting serum phosphate 4 weeks after dose adjustment.
Do not adjust CRYSVITA
more frequently than every 4 weeks
Missed or late dosing
To avoid missed doses, treatments may be administered 3 days either side of the scheduled treatment date. If a patient misses a dose, resume CRYSVITA as soon as possible at the prescribed dose.
CRYSVITA should be administered subcutaneously by a healthcare professional1
Inject in the arm, abdomen, buttock or thigh.
The maximum volume of CRYSVITA per injection site is 1.5 mL. If more than 1.5 ml is required on a given dosing day, the total volume of medicinal product must be split and administered at two or more different injection sites.
Injection sites should be rotated and carefully monitored for signs of potential reactions.
Recommended monitoring schedule for CRYSVITA patients1
|Fasting serum phosphate†|
|Month 1: Every 2 weeks|
|Month 2-3: Every 4 weeks|
|Thereafter: As appropriate|
|Following dose adjustment: 4 weeks after|
|Year 1: At start of treatment and every 6 months|
|Plasma ALP, calcium, PTH and creatinine|
|In children aged 1–2 years: Every 3 months, or as indicated|
|In children >2 years: Every 6 months, or as indicated|
|Urine calcium and phosphate||Every 3 months|
†It is recommended that fasting serum phosphate is targeted at the lower end of the normal reference for age.
Warnings and precautions
- CRYSVITA must not be given to patients with severe or end stage renal disease
- Safety and efficacy of CRYSVITA in children aged less than one year have not been established
- Co-administration of calcimimetic medicinal products* could potentially exacerbate hypocalcaemia
- CRYSVITA is not recommended during pregnancy and in women of childbearing potential not using contraception
- It is unknown whether CRYSVITA or it’s metabolites are excreted in human milk and a risk to newborns or infants cannot be ruled out. A discussion between the prescribing healthcare professional and patient should take place to make a decision whether to continue breastfeeding
*Agents that mimic the effect of calcium on tissues by activating the calcium receptor.
Store CRYSVITA away from light and in refrigerated conditions2
CRYSVITA is supplied as a clear to slightly opalescent, colourless to pale brownish-yellowish solution. The product is available as one single-dose vial per pack in the following strengths: 10, 20, and 30 mg/mL.
Store under refrigerated conditions at 2°C to 8°C in the original package to protect from light until use.
Do not freeze or shake before use. CRYSVITA should not be used after the expiry date which is stated on the package and label. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.