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Crysvita

Crysvita

Manufacturer:

Kyowa Kirin

Distributor:

DCH Auriga - Healthcare
Concise Prescribing Info
Contents
Burosumab
Indications/Uses
X-linked hypophosphatemia (XLH) in adult & ped patients ≥1 yr.
Dosage/Direction for Use
SC Max vol: 1.5 mL/inj. Adult ≥18 yr 1 mg/kg rounded to the nearest 10 mg up to a max dose of 90 mg, administered every 4 wk. Ped patient 1 to <18 yr, weighing <10 kg 1 mg/kg rounded to the nearest 1 mg, administered every 2 wk; weighing ≥10 kg 0.8 mg/kg rounded to the nearest 10 mg, administered every 2 wk up to a max dose of 90 mg.
Contraindications
Concomitant use w/ oral phosphate &/or active vit D analogs (eg, calcitriol, paricalcitol, doxercalciferol, calcifediol). When serum P is w/in or above the normal range for age. Patients w/ severe renal impairment or end stage renal disease.
Special Precautions
Hypersensitivity. Hyperphosphatemia associated w/ increased risk of nephrocalcinosis. Administration may result in local inj site reactions. Pregnancy & lactation. Ped <1 yr. Elderly ≥65 yr.
Adverse Reactions
Headache. Adult: Back pain, tooth infection, restless leg syndrome, decreased vit D, dizziness, constipation, muscle spasms, increased blood P. Ped: Pyrexia, inj site reaction, cough, vomiting, pain in extremity, tooth abscess, dental caries.
Drug Interactions
Increased phosphate conc w/ oral phosphate &/or active vit D analogs.
ATC Classification
M05BX05 - burosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Crysvita soln for inj 10 mg/mL
Packing/Price
1's
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