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Crysvita Generic Name & Formulations
Legal Class
Rx
General Description
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Fibroblast growth factor 23 (FGF23) blocking antibody.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Crysvita Indications
Indications
Treatment of X-linked hypophosphatemia (XLH) in patients aged ≥6 months. Treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in patients aged ≥2 years.
Crysvita Dosage and Administration
Adult
Discontinue oral phosphate and/or active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. ≥18yrs: XLH: 1mg/kg every 4 weeks; max 90mg. TIO: initially 0.5mg/kg every 4 weeks; max 2mg/kg up to 180mg every 2 weeks. Assess fasting serum phosphorus every 4 weeks, measured 2 weeks post-dose, for the first 3 months, 2 weeks after a dose adjustment, then thereafter as needed. Dose adjustment: see full labeling.
Children
Discontinue oral phosphate and/or active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 1mg (<10kg) or 10mg (≥10kg); max 1.5mL per inj site. XLH: <6mos: not established. 6mos–<18yrs (<10kg): initially 1mg/kg every 2 weeks; (≥10kg): initially 0.8mg/kg every 2 weeks, max 90mg. TIO: <2yrs: not established. 2yrs–<18yrs: initially 0.4mg/kg every 2 weeks; max 2mg/kg up to 180mg. Assess fasting serum phosphorus every 4 weeks (TIO: also measured 2 weeks post-dose), for the first 3 months, 4 weeks after a dose adjustment, then thereafter as needed. Dose adjustment: see full labeling.
Crysvita Contraindications
Contraindications
Concomitant oral phosphate and/or active vitamin D analogs (eg, calcitriol, paricalcitol, doxercalciferol, calcifediol). Serum phosphorus within or above normal range for age. Severe renal impairment or ESRD.
Crysvita Boxed Warnings
Not Applicable
Crysvita Warnings/Precautions
Warnings/Precautions
Prior to initiation, confirm fasting serum phosphorus concentration below reference range for age. Monitor 25-hydroxy vitamin D levels; supplement with cholecalciferol or ergocalciferol to maintain normal range for age. Discontinue if serious hypersensitivity or severe inj site reactions occur. Elderly. Pregnancy. Nursing mothers.
Crysvita Pharmacokinetics
See Literature
Crysvita Interactions
Interactions
Risk of hyperphosphatemia when concomitant with oral phosphate and/or active vitamin D analogs.
Crysvita Adverse Reactions
Adverse Reactions
Back pain, headache, tooth infection, restless leg syndrome, vitamin D decreased, dizziness, constipation, muscle spasms, blood phosphorus increased, tooth abscess, inj site reaction, rash; hypersensitivity, hyperphosphatemia, nephrocalcinosis. In children: pyrexia, inj site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries.
Crysvita Clinical Trials
See Literature
Crysvita Note
Not Applicable
Crysvita Patient Counseling
See Literature
Crysvita Generic Name & Formulations
Legal Class
Rx
General Description
Burosumab-twza 10mg/mL, 20mg/mL, 30mg/mL; soln for SC inj; preservative-free.
Pharmacological Class
Fibroblast growth factor 23 (FGF23) blocking antibody.
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Crysvita Indications
Indications
Treatment of X-linked hypophosphatemia (XLH) in patients aged ≥6 months. Treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in patients aged ≥2 years.
Crysvita Dosage and Administration
Adult
Discontinue oral phosphate and/or active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 10mg; max 1.5mL per inj site. ≥18yrs: XLH: 1mg/kg every 4 weeks; max 90mg. TIO: initially 0.5mg/kg every 4 weeks; max 2mg/kg up to 180mg every 2 weeks. Assess fasting serum phosphorus every 4 weeks, measured 2 weeks post-dose, for the first 3 months, 2 weeks after a dose adjustment, then thereafter as needed. Dose adjustment: see full labeling.
Children
Discontinue oral phosphate and/or active vitamin D analogs 1 week prior to treatment start. Give as SC inj (eg, upper arms, upper thighs, buttocks, abdomen quadrant); rotate sites. Round to nearest 1mg (<10kg) or 10mg (≥10kg); max 1.5mL per inj site. XLH: <6mos: not established. 6mos–<18yrs (<10kg): initially 1mg/kg every 2 weeks; (≥10kg): initially 0.8mg/kg every 2 weeks, max 90mg. TIO: <2yrs: not established. 2yrs–<18yrs: initially 0.4mg/kg every 2 weeks; max 2mg/kg up to 180mg. Assess fasting serum phosphorus every 4 weeks (TIO: also measured 2 weeks post-dose), for the first 3 months, 4 weeks after a dose adjustment, then thereafter as needed. Dose adjustment: see full labeling.
Crysvita Contraindications
Contraindications
Concomitant oral phosphate and/or active vitamin D analogs (eg, calcitriol, paricalcitol, doxercalciferol, calcifediol). Serum phosphorus within or above normal range for age. Severe renal impairment or ESRD.
Crysvita Boxed Warnings
Not Applicable
Crysvita Warnings/Precautions
Warnings/Precautions
Prior to initiation, confirm fasting serum phosphorus concentration below reference range for age. Monitor 25-hydroxy vitamin D levels; supplement with cholecalciferol or ergocalciferol to maintain normal range for age. Discontinue if serious hypersensitivity or severe inj site reactions occur. Elderly. Pregnancy. Nursing mothers.
Crysvita Pharmacokinetics
See Literature
Crysvita Interactions
Interactions
Risk of hyperphosphatemia when concomitant with oral phosphate and/or active vitamin D analogs.
Crysvita Adverse Reactions
Adverse Reactions
Back pain, headache, tooth infection, restless leg syndrome, vitamin D decreased, dizziness, constipation, muscle spasms, blood phosphorus increased, tooth abscess, inj site reaction, rash; hypersensitivity, hyperphosphatemia, nephrocalcinosis. In children: pyrexia, inj site reaction, cough, vomiting, pain in extremity, headache, tooth abscess, dental caries.
Crysvita Clinical Trials
See Literature
Crysvita Note
Not Applicable
Crysvita Patient Counseling
See Literature
