Abbreviated Prescribing Information
CRYSVITA Abbreviated Product Information
CRYSVITA® (burosumab). Based on Singapore Package Insert. Kyowa Kirin Asia Pacific Pte Ltd; 2021
INDICATIONS AND USAGE
CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.
DOSAGE AND ADMINISTRATION
CRYSVITA is administered by subcutaneous injection and should be administered by a healthcare provider. Discontinue oral phosphate and active vitamin D analogs 1 week prior to initiation of treatment. Fasting serum phosphorus concentration should be below the reference range for age prior to initiation of treatment. For pediatric patients (1 to less than 18 years of age), the recommended 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. After initiation of treatment with CRYSVITA, measure fasting serum phosphorus every 4 weeks for the first 3 months of treatment, and thereafter as appropriate. For adult patients (18 years of age and older), the recommended 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.
CONTRAINDICATIONS
Do not use CRYSVITA with oral phosphate and active vitamin D analogs. Do not initiate CRYSVITA treatment if serum phosphorus is within or above the normal range for age. CRYSVITA is contraindicated in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.
WARNINGS AND PRECAUTIONS
Hypersensitivity: hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment. Hyperphosphatemia and Risk of Nephrocalcinosis: increases in serum phosphorus to above the upper limit of normal may be associated with an increased 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. 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.
ADVERSE REACTIONS
Adverse reactions (>10%) reported in pediatric patients during clinical trials were: injection site reactions, cough, headache, pyrexia, pain in extremity, vomiting, tooth abscess, vitamin D decreased, diarrhoea, rash, nausea, constipation, dental caries, dizziness and myalgia. Adverse reactions (>5%) reported in adult patients during clinical trials were: back pain, headache, tooth infection, restless legs syndrome, vitamin D decrease and dizziness, constipation and blood phosphorus increased.
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