UK Prescribing Information

▼ CRYSVITA® (Burosumab)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

Presentation: Each vial contains 10/20/30 mg burosumab in 1 mL solution for injection. Contains 45.91 mg/mL sorbitol. Indication: Treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. Dosage and Administration: At initiation, fasting serum phosphate concentration should be below the reference range for age. For subcutaneous use. Treatment should be initiated by a Physician experienced in the management of patients with metabolic bone diseases. Discontinue oral phosphate and active vitamin D analogues 1 week prior to initiation of treatment. Recommended starting dose in children and adolescents aged 1 to 17 years is 0.8 mg/kg of bodyweight every 2 weeks. Maximum dose 90 mg. Round dose to the nearest 10 mg. Dose conversion at age 18 years: At 18 years of age, the patient should convert to the adult dose and dosing regimen. Recommended starting dose in adults is 1.0 mg/kg of bodyweight every 4 weeks. Maximum dose 90 mg. Round dose to the nearest 10 mg. Inject in arm, abdomen, buttock or thigh, 1.5 ml max. volume per site. If >1.5 mL is required, split total volume over two sites. Rotate sites and monitor for signs of reactions. Dose Adjustments: Measure fasting serum phosphate and adjust dose accordingly (not more frequently than every 4 weeks) (see SmPC). Special Populations: Safety/efficacy not established in renal impairment and age <1 year. Limited data are available in patients over 65 years of age. Contraindications: Hypersensitivity to ingredients (Refer to SmPC). Concurrent administration with oral phosphate, active vitamin D analogues. Fasting serum phosphate above normal range for age. Severe renal impairment or end stage renal disease. Warnings and Precautions: Ectopic mineralisation: stop oral phosphate and active vitamin D analogues at least 1 week prior to treatment. Monitor for signs and symptoms of nephrocalcinosis at the start of treatment and every 6 months for the first year and annually thereafter. Monitor plasma alkaline phosphatases (ALP), calcium, parathyroid hormone (PTH) and creatinine every 6 months (3 months for children 1- 2 years). Monitor urine calcium and phosphate every 3 months. Hyperphosphataemia: monitor fasting serum phosphate. Dose interruption and/or reduction may be required. Measure post-prandial serum phosphate and PTH periodically. Injection site reactions: Administration should be interrupted in any patient experiencing severe injection site reactions. Hypersensitivity: discontinue CRYSVITA® if serious reactions occur. Drug Interactions: Concurrent oral phosphate and active vitamin D analogues contraindicated (increased risk of hyperphosphataemia and hypercalcaemia). Caution when combining with calcimimetic medicinal products (potential to exacerbate hypocalcaemia). Pregnancy and Lactation: CRYSVITA is not recommended during pregnancy and in women of childbearing potential not using contraception. There are no or limited amount of data in pregnant women. Studies in animals have shown reproductive toxicity. It is unknown whether burosumab/ metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. Undesirable effects (Refer to SmPC for full summary of safety profile): Mild or moderate hypersensitivity reactions (including: injection site rash, rash, urticaria, swelling face, dermatitis) were reported in 18% of paediatric patients and 6% of adult patients. The most common adverse drug effects in paediatric patients were: injection site reactions (56%), cough (56%), headache (50%), pyrexia (43%), pain in extremity (40%), vomiting (39%), tooth abscess (35%), vitamin D decrease (32%), diarrhoea (25%), rash (24%), nausea (15%), constipation (11%), dental caries (11%) and myalgia (11%). The most common adverse drug reactions in adult patients were: back pain (23%), headache (21%), tooth infection (19%), vitamin D decrease (15%), restless legs syndrome (13%), muscle spasms (12%), and dizziness (11%). Date of Preparation of Prescribing Information: September 2020. Legal Category: POM. Marketing Authorisation numbers and list price: 1 x CRYSVITA 10mg; EU/1/17/1262/001, £2,992. 1 x CRYSVITA 20 mg; EU/1/17/1262/002, £5,984. 1 x CRYSVITA 30 mg; EU/1/17/1262/003, £8,976. Marketing Authorisation holder: Kyowa Kirin Holdings B.V., Bloemlaan 2, 2132NP Hoofddorp, The Netherlands, +31 (0) 237200822.

CRYSVITA has a conditional Marketing Authorisation in Europe. A conditional authorisation in Europe is granted when a medical product meets an important medical need and when the availability and benefit to health outweighs the risk in additional data being required. The European regulatory agency will review new information on CRYSVITA annually and the Summary of Product Characteristics will be updated accordingly.