What is CRYSVITA used for?

1 INDICATIONS AND USAGE 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. ( 1.1 ) 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. ( 1.2 ) 1.1 X-linked

How does CRYSVITA work?

11 DESCRIPTION Burosumab-twza is a human immunoglobulin G subclass 1 (IgG1), anti-human fibroblast growth factor 23 (FGF23) antibody produced by recombinant DNA technology using Chinese hamster ovary cells.

What pharmaceutical form is CRYSVITA available in?

CRYSVITA: Roztwór do wstrzykiwań 10 mg (podskórnie)

Is CRYSVITA OTC or prescription only?

CRYSVITA requires a doctor's prescription.

What are the side effects of CRYSVITA?

6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hyperphosphatemia and Risk of Nephrocalcinosis [see Warnings and Precautions (5.2) ] Hypercalcemia [see Warnings and Precautions (5.3) Injection Site Reactions [see Warnings and Precautions (5.4) ] Most common adverse reactions (≥25% in the CRYSVITA group and > Active Control) in pediatric XLH patients are: pyrexia, injection site reaction,

Who should NOT take CRYSVITA?

4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ] . When serum phosphorus is within or above the normal range for age [see Warnings and Precautions (5.2) ] . In patients with severe renal impairment or end stage renal disease because these conditi

Does CRYSVITA interact with other medications?

7 DRUG INTERACTIONS 7.1 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.

Can CRYSVITA be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on CRYSVITA use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In utero, burosumab-twza exposure in cynomolgus monkeys did not result in teratogenic effects. Adverse effects such as late fetal loss and preterm birth were observed in pregnant cynomolgus monkeys, however, these effects are unlikely to indicate clinical risk because they occurred at a drug ex

What precautions should be taken with CRYSVITA?

Each vial is for single use only. Do not shake the vial before use. Burosumab should be administered using aseptic technique and sterile disposable syringes and injection needles. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures CRYSVITA?

Kyowa Kirin Holdings B.V. (Niemcy)

What ATC class does CRYSVITA belong to?

CRYSVITA: ATC M05BX05. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

CRYSVITA

10 mg, Roztwór do wstrzykiwań

INN: Burosumabum

Data updated: 2026-04-13

Available in:

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Form

Roztwór do wstrzykiwań

Dosage

10 mg

Route

podskórnie

Storage

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).‍‍‍‍‍‍‍‍‍‍‍‍‍ Keep CRYSVITA vial in the original carton to protect from light until time of use. Do not freeze or shake CRYSVITA. Do not use CRYSVITA beyond the expiration date stamped on the carton. CRYSVITA vials are single-dose only. Discard any unused product.

User Reviews

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