The safety profile of CRYSVITA was demonstrated in 94 children with XLH aged 1 to 12 years exposed for a mean duration of 98 weeks1
Adverse events reported in ≥10% of CRYSVITA-treated pediatric patients with higher frequency than the conventional therapy group in the Phase 3, active-controlled clinical trial1
| Adverse event |
CRYSVITA (n=29) n (%) |
Conventional therapy (n=32) n (%) |
|---|---|---|
| Pyrexia | 16 (55) | 6 (19) |
| Injection site reaction† | 15 (52) | 0 (0) |
| Cough‡ | 15 (52) | 6 (19) |
| Vomiting | 12 (41) | 8 (25) |
| Pain in extremity | 11 (38) | 10 (31) |
| Headache | 10 (34) | 6 (19) |
| Tooth abscess§ | 10 (34) | 4 (13) |
| Dental caries | 9 (31) | 2 (6) |
| Diarrhea | 7 (24) | 2 (6) |
| Vitamin D decreased¶ | 7 (24) | 1 (3) |
| Constipation | 5 (17) | 0 (0) |
| Rash†† | 4 (14) | 2 (6) |
| Nausea | 3 (10) | 1 (3) |
Adapted from the Product Monograph.1
Rates of serious treatment-emergent adverse events were comparable in both groups. Serious treatment-emergent adverse events of craniosynostosis, viral infection, and migraine were reported by 3 patients (10%) in the CRYSVITA group.1
No pediatric patients discontinued CRYSVITA due to adverse events.1
† Injection 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 hypersensitivity, injection site inflammation, injection site papule, injection site erosion, injection site discoloration, injection site discomfort, injection site hematoma, injection site hemorrhage, injection site induration, injection site macule, and injection site urticaria.
‡ Cough includes: cough and productive cough.
§ Tooth abscess includes: tooth abscess, tooth infection, toothache.
¶ Vitamin D decreased includes: vitamin D deficiency, blood 25-hydroxycholecalciferol decreased, and vitamin D decreased.
†† Rash includes: rash, rash pruritic, rash maculopapular, rash erythematous, rash generalized, and rash pustular.
Reference: 1. CRYSVITA (burosumab injection) Product Monograph. Kyowa Kirin Inc. March 15, 2023.
