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Crysvita

Crysvita

burosumab

Manufacturer:

Kyowa Kirin

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Burosumab
Indications/Uses
X-linked hypophosphataemia in adults; childn & adolescents 1-17 yr w/ radiographic evidence of bone disease.
Dosage/Direction for Use
SC Adult Recommended starting dose: 1 mg/kg, rounded to the nearest 10 mg up to 90 mg given every 4 wk. Childn & adolescent 1-17 yr Recommended starting dose: 0.8 mg/kg, rounded to the nearest 10 mg given every 2 wk. Max dose: 90 mg.
Contraindications
Hypersensitivity. Fasting serum phosphate above the normal range for age due to the risk of hyperphosphatemia. Concurrent w/ oral phosphate, active vit D analogues. Severe renal impairment or ESRD.
Special Precautions
Discontinue use at least 1 wk prior to treatment in patients treated w/ oral phosphate & active vit D analogues; if serious hypersensitivity reactions occur. Interrupt administration if patient experiences severe inj site reactions. Monitor for signs & symptoms of nephrocalcinosis, by renal ultrasonography at start of treatment & every 6 mth for 1st 12 mth of treatment, & annually thereafter. Monitor plasma alkaline phosphatase, Ca, parathyroid hormone & creatinine every 6 mth (every 3 mth for childn 1-2 yr); urine Ca & phosphate every 3 mth; levels of fasting serum phosphate. Periodic measurement of post-prandial serum phosphate & parathyroid hormone. May affect ability to drive & use machines. Not to be given in patients w/ severe renal disease or ESRD. Not recommended in women of childbearing potential not using contraception & during pregnancy. Lactation. Childn <1 yr. Elderly >65 yr.
Adverse Reactions
Tooth infection/abscess; headache, dizziness; decreased vit D; constipation. Adult: Restless legs syndrome; back pain, muscle spasms. Increased blood P. Ped patient: Cough; vomiting, nausea, diarrhoea, dental caries; rash; myalgia, pain in extremity; inj site reaction, pyrexia.
Drug Interactions
Increased risk of hyperphosphatemia & hypercalcaemia w/ oral phosphate & active vit D analogues. Potentially exacerbate hypocalcaemia in combination w/ calcimimetic medicinal products.
MIMS Class
Other Drugs Acting on Musculo-Skeletal System
ATC Classification
M05BX05 - burosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Crysvita soln for inj 10 mg/mL
Packing/Price
1's
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