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CRYSVITA (burosumab-twza)
- X-linked hypophosphatemic osteomalacia
10 mg/mL subcutaneous solution
- Inject 1 mg/kg by subcutaneous route every 4 weeks (round to nearest 10 mg up to max dose of 90 mg) ; maximum of 1.5 ml per injection site
20 mg/mL subcutaneous solution
- Inject 1 mg/kg by subcutaneous route every 4 weeks (round to nearest 10 mg up to max dose of 90 mg) ; maximum of 1.5 ml per injection site
30 mg/mL subcutaneous solution
- Inject 1 mg/kg by subcutaneous route every 4 weeks (round to nearest 10 mg up to max dose of 90 mg) ; maximum of 1.5 ml per injection site
X-linked hypophosphatemic osteomalacia
- Inject 1 mg/kg by subcutaneous route every 4 weeks (round to nearest 10 mg up to max dose of 90 mg) ; maximum of 1.5 ml per injection site
- None
Contraindicated
- None
Severe
Moderate
- None
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Contraindicated
- Kidney disease with likely reduction in GFR
Severe
Moderate
- None
CRYSVITA (burosumab-twza)
- X-linked hypophosphatemic osteomalacia
- Vitamin D deficiency
- Back pain
- Constipation
- Cough
- Dental caries
- Dizziness
- Fever
- Headache disorder
- Injection site sequelae
- Limb pain
- Muscle spasm
- Pain
- Restless legs syndrome
- Toothache
- Vomiting
More Frequent
Severe
Less Severe
- Dental abscess
- Hyperphosphatemia
- Hypersensitivity drug reaction
- Skin rash
- Urticaria
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Nephrocalcinosis
Less Severe
- None
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Burosumab-twza
No safety and efficacy established age < 6 months.
- 1 Day – 179 Days
- No safety and efficacy established age < 6 months.
Burosumab-twza
- Severity Level:
2
- Additional Notes: Insufficient data available
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Burosumab-twza
Insufficient data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| X-linked hypophosphatemic osteomalacia | |
| E83.31 | Familial hypophosphatemia |
| 0-9 | A-Z |
|---|---|
| E83.31 | Familial hypophosphatemia |
Formulary Reference Tool