Burosumab is a prescription medicine indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Burosumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older. The treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For subcutaneous use only. Prior to starting CRYSVITA, discontinue oral phosphate and/or active vitamin D analogs for one week. Pediatric XLH (6 months and older): For patients who weigh less than 10 kg, starting dose regimen is 1 mg/kg of body weight rounded to the nearest 1 mg, administered every two weeks. For patients who weigh 10 kg and greater, starting dose regimen is 0.8 mg/kg of body weight rounded to the nearest 10 mg, administered every two weeks. The minimum starting dose is 10 mg up to a maximum dose of 90 mg. Dose may be increased up to approximately 2 mg/kg (maximum 90 mg), administered every two weeks to achieve normal serum phosphorus. Adult XLH: Starting dose is 1 mg/kg body weight rounded to the nearest 10 mg up to a maximum dose of 90 mg administered every four weeks.
Source: US FDA prescribing information
CRYSVITA is contraindicated: In concomitant use with oral phosphate and/or active vitamin D analogs (e.g. calcitriol, paricalcitol, doxercalciferol, calcifediol) due to the risk of hyperphosphatemia. When serum phosphorus is within or above the normal range for age. In patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism. With oral phosphate and/or active vitamin D analogs. In patients with severe renal impairment or end stage renal disease.
Source: US FDA prescribing information
Hypersensitivity: Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment. 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. Hypercalcemia: Increases in serum calcium have been reported. Monitor serum calcium and parathyroid hormone levels in patients at high risk for hypercalcemia before and during treatment. Injection Site Reactions: Administration of CRYSVITA may result in local injection site reactions. Discontinue CRYSVITA if severe injection site reactions occur and administer appropriate medical treatment.
Source: US FDA prescribing information
The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Hyperphosphatemia and Risk of Nephrocalcinosis Hypercalcemia Most common adverse reactions (≥25% in the CRYSVITA group and > Active Control) in pediatric XLH patients are: pyrexia, injection site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries. Most common adverse reactions (>5% and in at least 2 patients more than placebo) in adult XLH patients are: back pain, headache, tooth infection, restless legs syndrome, vitamin D decreased, dizziness, constipation, muscle spasms, blood phosphorus increased. Most common adverse reactions (>10%) in TIO patients are: tooth abscess, muscle spasms, dizziness, constipation, injection site reaction, rash, and headache.
Source: US FDA prescribing information
Oral Phosphate and Active Vitamin D Analogs Concomitant use of CRYSVITA with oral phosphate and/or active vitamin D analogs will increase phosphate concentrations greater than expected with CRYSVITA alone. This increase may result in hyperphosphatemia which can induce nephrocalcinosis. Concomitant use of CRYSVITA with oral phosphate and/or active vitamin D analogs is contraindicated.
Source: US FDA prescribing information
CRYSVITA vials must be stored in the original carton until the time of use under refrigerated conditions at 36°F to 46°F (2°C to 8°C). Do not freeze or shake CRYSVITA. Keep CRYSVITA vial in the original carton to protect from light until time of use.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Burosumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Crysvita 10 mg/1 mL injectionSubcutaneous Cold chain | Kyowa Kirin | US FDA | Available on request |
| Crysvita 20 mg/1 mL injectionSubcutaneous Cold chain | Kyowa Kirin | US FDA | Available on request |
| Crysvita 30 mg/1 mL injectionSubcutaneous Cold chain | Kyowa Kirin | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 3 presentations of Burosumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Burosumab, including Crysvita.
Yes. The US FDA first approved Burosumab on 17 April 2018, according to Drugs@FDA.
Yes. Burosumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Burosumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Burosumab is classified under ATC code M05BX05 (Burosumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.