Crysvita (burosumab-twza) (Burosumab INJECTION) 10 mg/mL

Q: What is Crysvita used for?

Crysvita is used to treat X-linked Hypophosphatemia (XLH) and Tumor-induced Osteomalacia (TIO), rare disorders characterized by abnormal phosphate metabolism and bone mineralization defects. It works by targeting fibroblast growth factor 23 (FGF23), the underlying pathogenic factor in both conditions. By inhibiting FGF23, Crysvita increases serum phosphate and vitamin D levels, improving bone health and reducing rickets progression.

Q: How is Crysvita administered?

Crysvita is administered as a subcutaneous injection, typically given every 2 weeks or as directed by a healthcare provider. The dose is individualized based on serum phosphate levels and clinical response. Patients can receive injections in a clinical setting or learn to self-administer at home, providing flexibility and convenience in treatment management.

Q: What are the common side effects of Crysvita?

Common side effects include injection site reactions such as redness, swelling, or pain at the injection site, headache, and elevated serum phosphate levels. Most injection site reactions are mild and resolve without intervention. Serious adverse events may include hyperphosphatemia and hypercalcemia, requiring regular laboratory monitoring to ensure safety.

Q: Who manufactures Crysvita?

Crysvita is manufactured by Kyowa Kirin North America, a pharmaceutical company specializing in rare disease therapeutics and specialty medicines.

Q: Is Crysvita an orphan drug?

Yes, Crysvita received FDA Orphan Drug Designation for both X-linked Hypophosphatemia and Tumor-induced Osteomalacia, recognizing these as rare diseases affecting fewer than 200,000 individuals in the United States. This designation provides regulatory incentives and support for development of treatments for these uncommon but serious conditions.

Crysvita (burosumab) is an FDA-approved monoclonal antibody therapeutic indicated for X-linked Hypophosphatemia (XLH) and Tumor-induced Osteomalacia (TIO). Manufactured by Kyowa Kirin North America, it represents a breakthrough in endocrine and bone metabolism disorders, offering the first targeted mechanism to address the underlying pathophysiology of these rare phosphate-wasting conditions.

Strength

10 mg/mL

Pack Size

1 mL in 1 VIAL, SINGLE-USE (42747-102-01)

Manufacturer / TM Owner

Kyowa Kirin North America

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Indications & Clinical Uses

Crysvita is used to treat X-linked Hypophosphatemia (XLH), a rare genetic disorder characterized by renal phosphate wasting, hypophosphatemia, and impaired bone mineralization, as well as Tumor-induced Osteomalacia (TIO), a paraneoplastic syndrome causing similar metabolic abnormalities. The drug targets fibroblast growth factor 23 (FGF23), a key pathogenic factor in both conditions. By inhibiting FGF23 signaling, Crysvita increases serum phosphate levels and 1,25-dihydroxyvitamin D, thereby improving bone mineralization and reducing rickets progression in pediatric and adult patients. The patient population includes children and adults with confirmed XLH or TIO diagnoses. Crysvita is administered as a subcutaneous injection, allowing for convenient outpatient or home-based therapy, improving quality of life compared to conventional oral phosphate supplementation and active vitamin D analogs.

Side Effects

Common adverse effects include injection site reactions (erythema, induration, pain), headache, and elevated serum phosphate levels. Serious adverse events may include hyperphosphatemia with associated complications, hypercalcemia, and secondary hyperparathyroidism. Patients require regular monitoring of serum phosphate, calcium, alkaline phosphatase, parathyroid hormone (PTH), and renal function. Ophthalmologic examination is recommended to monitor for complications. Dental assessments are advised given the impact on bone mineralization. Laboratory monitoring should occur at baseline, 4 weeks post-initiation, and periodically thereafter to ensure therapeutic efficacy and prevent metabolic complications.

Precautions & Warnings

Crysvita is contraindicated in patients with severe renal impairment (eGFR <15 mL/min/1.73m²) due to increased hyperphosphatemia risk. Caution is warranted in patients with chronic kidney disease, cardiovascular disease, or history of seizures. Pregnancy Category C; use only if benefits outweigh risks. Pediatric use is supported by clinical evidence in children with XLH. Hepatic impairment does not require dose adjustment. Monitor for signs of hyperphosphatemia, hypercalcemia, and secondary hyperparathyroidism. Patients with parathyroid disorders or those on concurrent phosphate-binding agents require careful management and dose titration.

Avoid Interactions

Crysvita may interact with phosphate-binding agents, requiring dose adjustments or timing separation. Concurrent use of active vitamin D analogs or phosphate supplements may increase hyperphosphatemia risk and requires careful monitoring. No significant interactions with CYP450 enzymes reported. Patients should maintain consistent dietary phosphate and calcium intake. NSAIDs and other nephrotoxic agents warrant caution due to potential renal function impacts. Consultation with healthcare providers is essential before initiating concurrent medications affecting phosphate or calcium metabolism.

Frequently Asked Questions

Crysvita is used to treat X-linked Hypophosphatemia (XLH) and Tumor-induced Osteomalacia (TIO), rare disorders characterized by abnormal phosphate metabolism and bone mineralization defects. It works by targeting fibroblast growth factor 23 (FGF23), the underlying pathogenic factor in both conditions. By inhibiting FGF23, Crysvita increases serum phosphate and vitamin D levels, improving bone health and reducing rickets progression.

Crysvita is administered as a subcutaneous injection, typically given every 2 weeks or as directed by a healthcare provider. The dose is individualized based on serum phosphate levels and clinical response. Patients can receive injections in a clinical setting or learn to self-administer at home, providing flexibility and convenience in treatment management.

Common side effects include injection site reactions such as redness, swelling, or pain at the injection site, headache, and elevated serum phosphate levels. Most injection site reactions are mild and resolve without intervention. Serious adverse events may include hyperphosphatemia and hypercalcemia, requiring regular laboratory monitoring to ensure safety.

Crysvita is manufactured by Kyowa Kirin North America, a pharmaceutical company specializing in rare disease therapeutics and specialty medicines.

Yes, Crysvita received FDA Orphan Drug Designation for both X-linked Hypophosphatemia and Tumor-induced Osteomalacia, recognizing these as rare diseases affecting fewer than 200,000 individuals in the United States. This designation provides regulatory incentives and support for development of treatments for these uncommon but serious conditions.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated: 17 Jun 2026

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