← Search & browse all drugs

burosumab

M05BX05

Forms & Strengths

Injection: 10 mg/mL, 20 mg/mL, 30 mg/mL in single-dose vials

Adult Dosing

X-linked hypophosphatemia (XLH): 1 mg/kg subcutaneously every 4 weeks (maximum initial dose 90 mg)

Pediatric Dosing

XLH (Patients 6 months to 17 years): 0.8 mg/kg subcutaneously every 2 weeks (rounded to nearest 10 mg, max 90 mg)
Tumor-induced osteomalacia (TIO) (Patients 2 years and older): 0.5 mg/kg subcutaneously every 4 weeks, titrated up to 2 mg/kg based on serum phosphorus

Indications

Treatment of X-linked hypophosphatemia in adult and pediatric patients 6 months of age and older
Treatment of tumor-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be surgically resected or localized in patients 2 years of age and older

Mechanism of Action

Recombinant fully human monoclonal IgG1 antibody that binds to and inhibits fibroblast growth factor 23 (FGF23)
Reduces FGF23-mediated suppression of tubular phosphate reabsorption and 1,25-dihydroxyvitamin D production, increasing serum phosphorus and active vitamin D levels

Contraindications

Concomitant oral phosphate replacements or active vitamin D analogs
Baseline serum phosphorus above the normal range for age
Severe hypersensitivity to burosumab or any of its excipients

Adverse Reactions

Injection site reactions
Hypersensitivity
Headache
Nasopharyngitis
Nausea
Restless legs syndrome
Vitamin D deficiency
Hyperphosphatemia

Drug Interactions

Oral phosphate and active vitamin D analogs: Contraindicated due to risk of hyperphosphatemia and hypercalciuria
Thiazide diuretics: May increase the risk of hypercalcemia

Curated Content: Needs Vetting Before Put to Clinical Use