Active Ingredient: Burosumab
Burosumab is indicated for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
0.4 - 2 mg per kg of body weight
From 0.4 To 2 mg per kg of body weight once every 14 day(s)
Oral phosphate and vitamin D analogues should be discontinued 1 week prior to initiation of treatment. At initiation, fasting serum phosphate concentration should be below the reference range for age.
The recommended starting dose is 0.4 mg/kg of body weight and the normal maintenance dose is 0.8 mg/kg burosumab given every two weeks. The maximum dose is 90 mg. All doses should be rounded to the nearest 10 mg.
After initiation of treatment with burosumab, fasting serum phosphate should be measured every 2 weeks for the first month of treatment, every 4 weeks for the following 2 months and thereafter as appropriate. Fasting serum phosphate should also be measured 4 weeks after any dose adjustment. If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age.
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 2.0 mg/kg (maximum dose of 90 mg). Fasting serum phosphate should be measured 4 weeks after dose adjustment. Burosumab should not be adjusted more frequently than every 4 weeks.
If fasting serum phosphate is above the reference range for age, the next dose should be withheld and the fasting serum phosphate reassessed within 4 weeks. The patient must have fasting serum phosphate below the reference range for age to restart burosumab at approximately half of the previous dose.
If a patient misses a dose, burosumab should be resumed as soon as possible at previously prescribed dose.
Burosumab should be injected in the arm, abdomen, buttock or thigh. The maximum volume of medicinal product 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 should be split and should be administered at two different injection sites. Injections sites should be rotated and carefully monitored for signs of potential reactions.
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