Select therapeutic use:

Bone disorders:

Indications for CRYSVITA:

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.

Adult Dosage:

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 Dosage:

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:

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 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 Classification:

Fibroblast growth factor 23 (FGF23) blocking antibody.

CRYSVITA Interactions:

Risk of hyperphosphatemia when concomitant with oral phosphate and/or active vitamin D analogs.

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1

Inborn errors of metabolism:

Indications for CRYSVITA:

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.

Adult Dosage:

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 Dosage:

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:

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 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 Classification:

Fibroblast growth factor 23 (FGF23) blocking antibody.

CRYSVITA Interactions:

Risk of hyperphosphatemia when concomitant with oral phosphate and/or active vitamin D analogs.

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.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1