The safety profile of CRYSVITA was demonstrated in 175 adults with XLH exposed for a mean duration of 61 weeks1
Adverse events occurring in >5% of CRYSVITA-treated adult patients and in at least 2 patients more than with placebo from the 24-week placebo-controlled period of the Phase 3 study1
| Adverse event |
CRYSVITA (n=68) n (%) |
Placebo (n=66) n (%) |
|---|---|---|
| Back pain | 10 (15) | 6 (9) |
| Headache† | 9 (13) | 6 (9) |
| Tooth infection‡ | 9 (13) | 6 (9) |
| Restless legs syndrome | 8 (12) | 5 (8) |
| Vitamin D decreased§ | 8 (12) | 3 (5) |
| Dizziness | 7 (10) | 4 (6) |
| Constipation | 6 (9) | 0 (0) |
| Muscle spasm | 5 (7) | 2 (3) |
| Blood phosphorus increased¶ |
4 (6) | 0 (0) |
Adapted from the Product Monograph.1
† Headache includes: headache and head discomfort.
‡ Tooth infection includes: tooth abscess and tooth infection.
§ Vitamin D decreased includes: vitamin D deficiency, blood 25-hydroxycholecalciferol decreased, and vitamin D decreased.
¶ Blood phosphorus increased includes: blood phosphorus increased and hyperphosphatemia.
Reference: CRYSVITA (burosumab injection) Product Monograph. Kyowa Kirin Inc. March 15, 2023.
