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Crysvita is a brand name for Burosumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: CRYSVITA is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. CRYSVITA is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by a physician experienced in the management of patients with metabolic bone diseases. g. calcitriol) must be discontinued 1 week prior to initiation of treatment. 1), patients’ requirements for replacement or supplementation with inactive vitamin D should be assessed.
Vitamin D replacement or supplementation with inactive forms may be started or continued as per local guidelines under monitoring of serum calcium and phosphate. 3). 4). 8 mg/kg of body weight given every two weeks. Doses should be rounded to the nearest 10 mg.
The maximum dose is 90 mg. Fasting serum phosphate should be monitored as appropriate during treatment with burosumab, including after any dose adjustment, to ensure that it remains within the reference range for age. Blood samples for measurement of serum phosphate must always be obtained approximately 2 weeks post dose.
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. If fasting serum phosphate is within the reference range for age, the same dose should be maintained.
If fasting serum phosphate is not within the reference range, dose adjustment (dose increase/dose decrease) may be required (see below). Fasting serum phosphate should be re-measured 4 weeks after any dose adjustment. If fasting serum phosphate is within reference range at remeasurement, the new dose should be maintained, otherwise further dose adjustment should be considered.
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. Dose decrease If fasting serum phosphate is above the reference range for age, the next dose should be withheld and the fasting serum phosphate reassessed within 2 weeks.
The patient must have fasting serum phosphate below the reference range for age to restart burosumab at half of the previous dose, rounding the amount as described above. If the level remains below the reference range after the first re-initiation dose, the dose can be increased as described under “Dose increase” (above).
Dose Conversion at age 18 years Children and adolescents aged 1 to 17 years should be treated using the dosing guidance outlined above. At 18 years of age the patient should convert to the adult dose and dosing regimen as outlined below.
Summary of the safety profile The most common (> 10%) adverse drug reactions reported in paediatric patients with XLH during clinical trials based on completed long term studies up to a maximum exposure to burosumab of 214 weeks (with variable period of exposure across the safety population) were: cough (55%), injection site reactions (54%), pyrexia (50%), headache (48%), vomiting (46%), pain in extremity (42%), tooth 10 abscess (40%), vitamin D decreased (28%), diarrhoea (27%), nausea (21%), rash (20%), constipation (12%), and dental caries (11%).
4 and ‘Description of selected adverse reactions’ below). Tabulated lists of adverse reactions The frequencies of adverse reactions are listed in Table 1 (XLH, paediatric patients), and Table 2 (XLH and TIO adult patients). The adverse reactions are presented by system organ class and frequency categories, defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1000); very rare (< 1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4)12 1 Tooth infection includes: tooth abscess, tooth infection and toothache 2Hyperparathyroidism includes: Hyperparathyroidism, Hyperparathyroidism secondary and Hyperparathyroidism tertiary 3Hypercalcaemia includes: Hypercalcaemia and Blood calcium increased 4Seen in clinical trials with TIO, confirmed by post-marketing experience 5Seen in clinical trials with XLH, confirmed by post-marketing experience 6Hypercalciuria includes: Hypercalciuria and Urine calcium increased 7Headache includes: headache and head discomfort 8Rash includes: rash, rash papular and rash erythematous 9Injection site reaction includes: Injection site reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site pain, Injection site rash, Injection site bruising, Injection site discolouration, Injection site discomfort, Injection site haematoma, Injection site haemorrhage, Injection site induration, Injection site macule, Injection site urticaria, Injection site hypersensitivity and Injection site inflammation 10Vitamin D […]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded within the patient’s records. 2). g. by renal ultrasonography, is recommended at the start of treatment and every 6 months for the first 12 months of treatment, and annually thereafter.
Monitoring of plasma alkaline phosphatase, calcium, parathyroid hormone (PTH) and creatinine is recommended every 6 months (every 3 months for children 1-2 years) or as indicated. Monitoring of urine calcium and phosphate is suggested every 3 months.
Hyperphosphataemia Levels of fasting serum phosphate should be monitored due to the risk of hyperphosphatemia. To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted 8 in the lower end of the normal reference range for age.
2). Periodic measurement of post prandial serum phosphate is advised. To prevent hyperphosphataemia, treatment with burosumab should be interrupted in patients with tumour-induced osteomalacia who undergo treatment of the underlying tumour.
2). Hypercalcaemia and hyperparathyroidism Increases in serum calcium or parathyroid hormone have been reported in patients treated with burosumab. Factors such as hyperparathyroidism, prolonged immobilisation, dehydration, hypervitaminosis D or renal impairment may increase the risk of hypercalcaemia.
In particular, severe hypercalcaemia has been reported in subjects with tertiary hyperparathyroidism. 2). In patients with moderate to severe hypercalcaemia (>3 mmol/l), burosumab should not be administered until hypercalcaemia is adequately treated.
Injection site reactions Administration of burosumab may result in local injection site reactions. 8) and appropriate medical therapy administered. Hypersensitivity Therapeutic proteins, such as burosumab, may be associated with hypersensitivity reactions.
1. 5). 4). Patients with severe renal impairment or end stage renal disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 mg/kg of body weight, rounded to the nearest 10 mg up to a maximum dose of 90 mg, given every 4 weeks. 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 be measured 2 weeks after the previous dose of burosumab. If serum phosphate is within the normal range, the same dose should be continued. Dose decrease If serum phosphate is above the upper limit of normal range, the next dose should be withheld and the serum phosphate level reassessed within 2 weeks.
The patient must have serum phosphate below the normal range before restarting burosumab. Once serum phosphate is below the normal range, treatment may be restarted at half the initial starting dose up to a maximum dose of 40 mg every 4 weeks.
Serum phosphate should be reassessed 2 weeks after any change in dose. 0 mg/kg, rounded to the nearest 10 mg (to a maximum (total) administration dose of 90 mg), administered every 4 weeks. Serum phosphate levels should be reassessed 2 weeks after dose adjustment.
4 mg/kg of body weight, given every 2 weeks. Doses should be rounded to the nearest 10 mg. The maximum dose is 90 mg. Dose increase If serum phosphate is below the reference range for age, the dose may be increased in a stepwise manner.
0 mg/kg), rounding the amount as described above, up to a maximum dose of 90 mg, given every 2 weeks. Fasting serum phosphate should be measured 4 weeks after dose adjustment. Burosumab should not be adjusted more frequently than every 4 weeks.
3 mg/kg of body weight, given every 2 weeks. Doses should be rounded to the nearest 10 mg. The maximum dose is 180 mg. Dose increase If serum phosphate is below the reference range for age, the dose may be increased in a stepwise manner.
Doses should be increased by […]
8). Burosumab must be discontinued if serious hypersensitivity reactions occur and appropriate medical treatment should be initiated. 91 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
5 mg/ml. Polysorbates may cause allergic reactions. 91 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. 5 mg/ml. Polysorbates may cause allergic reactions. 91 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.
5 mg/ml. Polysorbates may cause allergic reactions. 91 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product. 5 mg/ml. Polysorbates may cause allergic reactions.