BUROSUMAB

Other

Brand names: CRYSVITA

Subcutaneous

Mechanism of Action

12.1 Mechanism of Action X-linked hypophosphatemia is caused by excess fibroblast growth factor 23 (FGF23) which suppresses renal tubular phosphate reabsorption and the renal production of 1,25 dihydroxy vitamin D. Burosumab-twza binds to and inhibits the biological activity of FGF23 restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol
• paricalcitol
• doxercalciferol

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypersensitivity : Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment
1 ) Hyperphosphatemia and Risk of Nephrocalcinosis : For patients already taking CRYSVITA, dose interruption and/or dose reduction may be required based on a patient's serum phosphorus levels
Monitor serum calcium and parathyroid hormone levels in patients at high risk for hypercalcemia before and during treatment
Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment [see Adverse Reactions (6

Known Side Effects

6 documented side effects by frequency

Joint Pain

1-10%

Limb Pain

1-10%

Headache

1-10%

Injection Site Pain

0.1-1%

Fatigue

0.1-1%

Back Pain

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Subcutaneous