ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Burosumab: Drug information

Burosumab: Drug information
(For additional information see "Burosumab: Patient drug information" and see "Burosumab: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Crysvita
Brand Names: Canada
  • Crysvita
Pharmacologic Category
  • Anti-FGF23 Monoclonal Antibody;
  • Antineoplastic Agent, Monoclonal Antibody;
  • Monoclonal Antibody
Dosing: Adult

Note: Prior to initiating burosumab, oral phosphate and/or active vitamin D analogs (eg, calcitriol, paricalcitol, doxercalciferol, calcifediol) should be discontinued for at least 1 week; do not administer active vitamin D analogs during burosumab treatment. Confirm baseline fasting serum phosphorus level is below the reference range for patient age before initiating burosumab. Monitor serum 25-hydroxy vitamin D levels; if necessary, supplement with cholecalciferol or ergocalciferol to maintain levels in the normal range for age.

Hypophosphatemia, X-linked

Hypophosphatemia, X-linked: SUBQ: Initial: 1 mg/kg every 4 weeks; calculated dose should be rounded to the nearest 10 mg; maximum dose: 90 mg.

Dosage adjustment based on serum phosphorus: Evaluate fasting serum phosphorus 2 weeks after treatment initiation and continue every 4 weeks for the first 12 weeks of therapy. Adjust dose accordingly based on fasting serum phosphorus level; see Reference Range for phosphorus age-based normal limits. Do not adjust dose more frequently than every 4 weeks.

If low serum phosphorus: There are no dosage adjustments provided in the manufacturer's labeling.

If normal serum phosphorus: Continue same dose.

If high serum phosphorus:

If fasting serum phosphorus above the normal age-based range, withhold next dose and reassess in 4 weeks; once serum phosphorus falls below the age-based normal range, may reinitiate burosumab at approximately one-half the initial starting dose up to a maximum dose of 40 mg every 4 weeks:

Burosumab Reinitiation Dosing

Previous dose (mg/dose) every 4 weeks

Reinitiation dosea (mg/dose) every 4 weeks

aRecheck fasting serum phosphorus 2 weeks after dose adjustment; based on results, determine if additional dosing adjustment necessary.

40

20

50

20

60

30

70

30

≥80

40

Osteomalacia, tumor-induced

Osteomalacia, tumor-induced: SUBQ: Initial: 0.5 mg/kg once every 4 weeks; round dose to the nearest 10 mg; maximum dose: 2 mg/kg (not to exceed 180 mg) every 2 weeks.

Dosage adjustment based on serum phosphorus: Evaluate fasting serum phosphorus monthly, measured 2 weeks postdose, for the first 3 months of treatment and as clinically necessary thereafter. Adjust dose accordingly based on fasting serum phosphorus level; see "Reference Range" for phosphorus age-based normal limits. Reassess fasting serum phosphorus level 2 weeks after dose adjustment; do not adjust dose more frequently than every 4 weeks.

If serum phosphorus is normal: Continue the same burosumab dose.

If serum phosphorus is above the normal range: Withhold the next burosumab dose and reassess serum phosphorus in 4 weeks; the serum phosphorus level must be below the reference range to reinitiate burosumab. Reinitiate at approximately one-half of the initial starting dose (up to a maximum of 180 mg every 2 weeks). Reassess serum phosphorus 2 weeks after the dose adjustment. If the level remains below the reference range, the dose can be adjusted upward (see table: "Burosumab Dose Increase Levels for Tumor-Induced Osteomalacia").

If serum phosphorus is below the normal range: Titrate burosumab dose as follows:

Burosumab Dose Increase Levels For Tumor-Induced Osteomalaciaa,b

Starting dose

First dose increasec

Second dose increasec

Third dose increasec

Fourth dose increase

Fifth dose increase (maximum dose)

aRound dose to the nearest 10 mg.

bDo not adjust burosumab dose more frequently than every 4 weeks.

cIf serum phosphorus is less than the lower limit of the normal range, may consider dividing total dose administered every 4 weeks and administering every 2 weeks.

dIf the calculated dose is >180 mg every 4 weeks, change to a divided dose administered every 2 weeks.

If serum phosphorus is below lower limit of normal 2 weeks postdose adjustment

0.5 mg/kg every 4 weeks

Increase to:

1 mg/kg every 4 weeks

Or

0.5 mg/kg every 2 weeks

Increase to:

1.5 mg/kg every 4 weeksd

Or

0.75 mg/kg every 2 weeks

Increase to:

2 mg/kg every 4 weeksd

Or

1 mg/kg every 2 weeks

Increase to:

1.5 mg/kg (not to exceed 180 mg) every 2 weeks

Increase to:

2 mg/kg (not to exceed 180 mg) every 2 weeks

Dose interruption: Interrupt burosumab therapy if undergoing treatment (eg, surgical excision, radiation therapy) of the underlying tumor; reassess serum phosphorus after underlying tumor treatment is complete. If serum phosphorus remains below the lower limit of normal, reinitiate burosumab at the initiation dose and then adjust as necessary to maintain serum phosphorus within the reference range (see table: "Burosumab Dose Increase Levels for Tumor-Induced Osteomalacia").

Missed dose: If a dose is missed, administer as soon as possible. To avoid missed doses, treatments may be administered 3 days on either side of the scheduled treatment date.

Dosing: Kidney Impairment: Adult

CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling.

CrCl <30 mL/minute: Use is contraindicated.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Burosumab: Pediatric drug information")

Note: Prior to initiating burosumab, oral phosphates and/or active vitamin D analogs (eg, calcitriol) should be discontinued for at least 1 week. Confirm that baseline fasting serum phosphorus concentration is below the reference range for patient age before initiating burosumab. During burosumab therapy, patients should have 25-hydroxy vitamin D levels monitored; supplement as necessary with cholecalciferol or ergocalciferol to maintain serum 25-hydroxy vitamin D levels in the normal range for age. Dose and interval are age-dependent; use extra precaution.

Hypophosphatemia, X-linked

Hypophosphatemia, X-linked (XLH):

Initial:

Infants ≥6 months, Children, and Adolescents <18 years:

Weight <10 kg: SubQ: 1 mg/kg/dose every 2 weeks; calculated dose should be rounded to the nearest 1 mg.

Weight ≥10 kg: SubQ: 0.8 mg/kg/dose every 2 weeks; minimum dose: 10 mg/dose; calculated dose should be rounded to the nearest 10 mg; maximum dose: 90 mg/dose.

Adolescents ≥18 years: SubQ: 1 mg/kg/dose every 4 weeks; calculated dose should be rounded to the nearest 10 mg; maximum dose: 90 mg/dose.

Monitoring of therapy: Evaluate fasting serum phosphorus every 4 weeks for first 12 weeks of therapy and as appropriate thereafter (eg, after dosing adjustments). Adjust dose accordingly based on fasting serum phosphorus level; see "Reference Range" for phosphorus age-based normal limits.

Dosing adjustment based on serum phosphorus:

If low serum phosphorus:

Infants ≥6 months, Children, and Adolescents <18 years: SubQ:

Weight <10 kg: If serum phosphorus below the reference range for age, increase dose to 1.5 mg/kg/dose every 2 weeks, rounded to the nearest 1 mg. Recheck fasting serum phosphorus 4 weeks after dose adjustment; burosumab should not be adjusted more frequently than every 4 weeks. If needed, dose may be further increased to the maximum dose of 2 mg/kg/dose.

Weight ≥10 kg: If serum phosphorus below the reference range for age, increase dose stepwise based on the following table. Recheck fasting serum phosphorus 4 weeks after dose adjustment; burosumab should not be adjusted more frequently than every 4 weeks. Maximum dose: 2 mg/kg/dose, not to exceed 90 mg/dose.

Weight-Band Dosing for Weight ≥10 kg, Age <18 Years: Fixed DosingA IncreasesB for XLH

Weight-band (kg)

Initial dose (mg/dose) every 2 weeks

1st dose increase to mg/dose every 2 weeks

2nd dose increase to mg/dose every 2 weeks

A Presented doses already rounded

B In trials, dose titration for every-2-week dosing was 0.2 mg/kg or 0.3 mg/kg (Carpenter 2018).

10 to <15

10

15

20

15 to <19

10

20

30

19 to <32

20

30

40

32 to <44

30

40

60

44 to <57

40

60

80

57 to <69

50

70

90

69 to <81

60

90

90

81 to <94

70

90

90

94 to <106

80

90

90

≥106

90

90

90

Adolescents ≥18 years: There are no dosage adjustments provided in the manufacturer's labeling for low serum phosphorus.

If normal serum phosphorus (ie, above the lower limit of reference range for age) and <5 mg/dL: Infants ≥6 months, Children, and Adolescents: Continue current dose; continue to monitor serum phosphorus as appropriate.

If high serum phosphorus:

Infants ≥6 months, Children, and Adolescents <18 years: If serum phosphorus >5 mg/dL: Hold next dose; reassess fasting serum phosphorus in 4 weeks and every 4 weeks thereafter; once serum phosphorus below reference range for age, may reinitiate burosumab at a reduced dose (see the following weight-directed re-initiation recommendations).

Re-initiation dosing: SubQ:

Patient weight <10 kg: Restart at 0.5 mg/kg/dose every 2 weeks; round dose to the nearest 1 mg. Recheck fasting serum phosphorus in 4 weeks and follow dosing adjustment recommendations based on result.

Patient weight ≥10 kg: See the following table. Recheck fasting serum phosphorus in 4 weeks and follow dosing adjustment recommendations based on result.

Re-Initiation Dosing for Weight ≥10 kg, Age <18 Years: Fixed Dosing for XLH

Previous dose (mg/dose) every 2 weeks

Re-initiation dose (mg/dose) every 2 weeks

10

5

15

10

20

10

30

10

40

20

50

20

60

30

70

30

80

40

90

40

Adolescents ≥18 years: If serum phosphorus above normal range: Hold next dose; reassess fasting serum phosphorus every 4 weeks; once serum phosphorus falls below the normal range, may reinitiate burosumab at a reduced dose (approximately half the initial starting dose; see the following table [maximum dose: 40 mg/dose]). Recheck fasting serum phosphorus 2 weeks after dose adjustment; based on results, determine if additional dosing adjustment necessary.

Re-Initiation Dosing: Age ≥18 Years for XLH

Previous dose (mg/dose) every 4 weeks

Re-initiation dose (mg/dose) every 4 weeks

40

20

50

20

60

30

70

30

≥80

40

Osteomalacia, tumor-induced

Osteomalacia, tumor-induced (TIO):

Initial:

Children ≥2 years and Adolescents <18 years: SubQ: 0.4 mg/kg/dose every 2 weeks; calculated dose should be rounded to the nearest 10 mg; maximum dose: 180 mg/dose.

Adolescents ≥18 years: SubQ: 0.5 mg/kg/dose every 4 weeks; calculated dose should be rounded to the nearest 10 mg; maximum dose: 180 mg/dose.

Monitoring of therapy: During the first 12 weeks of therapy, evaluate fasting serum phosphorus 2 weeks postdose and monthly thereafter or more frequently as appropriate (eg, after dosing adjustments). Adjust dose accordingly based on fasting serum phosphorus level; see "Reference Range" for phosphorus age-based normal limits. Do not adjust more frequently than every 4 weeks.

Dosing adjustment based on serum phosphorus:

If low serum phosphorus:

Children ≥2 years and Adolescents <18 years: SubQ: If serum phosphorus below the reference range for age, increase dose stepwise based on the following table. Recheck fasting serum phosphorus 4 weeks after dose adjustment; burosumab should not be adjusted more frequently than every 4 weeks. The following table addresses dose titration only up to 1.5 mg/kg/dose; further increases up to 2 mg/kg/dose may be used; maximum dose: 2 mg/kg/dose, not to exceed 180 mg/dose.

Weight-Band Dosing for Age <18 Years: Fixed DosingA Increases for TIO

Weight-band (kg)

Initial dose (mg/dose) every 2 weeks

1st dose increase to mg/dose every 2 weeks

2nd dose increase to mg/dose every 2 weeks

3rd dose increase to mg/dose every 2 weeks

ATable only includes dose titration only up to 1.5 mg/kg/dose; further increases up to 2 mg/kg/dose may be used.

10 to <15

5

10

15

20

15 to <19

5

10

20

25

19 to <32

10

20

25

30

32 to <44

10

30

40

50

44 to <57

20

40

50

70

57 to <69

20

50

70

90

69 to <81

30

60

80

100

81 to <94

30

70

100

120

94 to <106

40

80

110

140

≥106

40

90

130

160

Adolescents ≥18 years: SubQ: If serum phosphorus below the reference range for age, may increase monthly dose stepwise (see following table) or administer same dose divided every 2 weeks. Burosumab dose should not be adjusted more frequently than every 4 weeks. Maximum dose: 2 mg/kg/dose, not to exceed 180 mg/dose. Recheck fasting serum phosphorus 2 weeks after dose adjustment; burosumab should not be adjusted more frequently than every 4 weeks.

Weight-Based Dosing IncreasesA, B for Age ≥18 years for TIO

Initial dose

1st dose increase

2nd dose increase

3rd dose increase

4th dose increase

5th dose increase

ARound dose to the nearest 10 mg.

BIf the calculated dose is >180 mg every 4 weeks, change to a divided dose administered every 2 weeks. Maximum single dose: 180 mg/dose.

0.5 mg/kg every 4 weeks

1 mg/kg/dose every 4 weeks

OR

0.5 mg/kg/dose every 2 weeks

1.5 mg/kg/dose every 4 weeks

OR

0.75 mg/kg/dose every 2 weeks

2 mg/kg/dose every 4 weeks

OR

1 mg/kg every 2 weeks

1.5 mg/kg/dose every 2 weeks

2 mg/kg/dose every 2 weeks

If normal serum phosphorus:

Children ≥2 years and Adolescents: SubQ: If serum phosphorus within reference range for age, continue current dose; continue to monitor serum phosphorus as appropriate.

If high serum phosphorus:

Children ≥2 years and Adolescents: SubQ: If serum phosphorus above normal reference range for age: hold next dose; reassess fasting serum phosphorus every 4 weeks; once serum phosphorus falls below the reference range for age, may reinitiate burosumab at a reduced dose of approximately half the initial starting dose for age and weight; maximum dose: 180 mg/dose every 2 weeks. Recheck fasting serum phosphorus 4 weeks (if <18 years of age) and 2 weeks (if ≥18 years of age) after dose adjustment; based on results, determine if additional dosing adjustment necessary.

Dose interruption: Children ≥2 years and Adolescents: If underlying tumor is treated (eg, surgical excision or radiation therapy); hold burosumab doses during treatment; after treatment completed, reassess serum phosphorus; if is below the lower limit of normal for age restart burosumab at the original initiation dose for the patient.

Dosing: Kidney Impairment: Pediatric

Infants ≥6 months, Children, and Adolescents:

Mild to moderate impairment: There are no dosing adjustments provided in the manufacturer's labeling (has not been studied); use with caution. Increased serum phosphorus may occur with renal impairment; in addition, burosumab may also cause hyperphosphatemia with risk of nephrocalcinosis; serum phosphorus levels should be monitored very closely.

Severe renal impairment or end-stage renal disease: Use is contraindicated.

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling (has not been studied); use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Dermatologic: Eczema (adults: 11%), skin rash (10% to 27%)

Endocrine & metabolic: Vitamin D deficiency (children: 24% to 37%; adults: 7% to 12%)

Gastrointestinal: Constipation (9% to 17%), dental caries (children: 31%), diarrhea (children: 24%), toothache (children: 23%), tooth infection (adults: 13%), vomiting (children: 41% to 48%)

Immunologic: Antibody development (14% to 19%)

Infection: Tooth abscess (15% to 34%)

Local: Injection site reaction (children: 52% to 67%; adults: 15%)

Nervous system: Dizziness (10% to 15%), headache (children: 34% to 73%; adults: 11% to 13%), restless leg syndrome (adults: 7% to 12%)

Neuromuscular & skeletal: Back pain (adults: 15%), limb pain (children: 38% to 46%), muscle spasm (adults: 7% to 19%), myalgia (children: 17%)

Respiratory: Cough (children: 52%)

Miscellaneous: Fever (children: 44% to 55%)

1% to 10%:

Dermatologic: Rash at injection site (children: 10%), urticaria at injection site (children: 7%)

Endocrine & metabolic: Hyperphosphatemia (adults: ≤7%)

Gastrointestinal: Nausea (children: 10%)

Hypersensitivity: Hypersensitivity reaction (adults: 6% to 22%)

Contraindications

Concomitant use with 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 end-stage renal disease.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to burosumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hyperphosphatemia: Elevated serum phosphorus may increase the risk of nephrocalcinosis; dose reduction or interruption of therapy may be required. To prevent hyperphosphatemia, interrupt burosumab therapy in patients with tumor-induced osteomalacia receiving treatment for the underlying tumor. Reassess serum phosphorus after underlying tumor-related treatment has been completed; reinitiate and adjust burosumab dose as clinically necessary.

• Hypersensitivity: May cause hypersensitivity reactions (eg, rash, urticaria). Discontinue therapy immediately if serious hypersensitivity reactions occur.

• Injection site reactions: Local injection site reactions may occur. Most reactions are mild in severity, occur within 1 day of injection, and typically resolve within 1 to 3 days with no treatment. Discontinue use if severe injection site reactions occur.

Disease-related concerns:

• Restless leg syndrome: New onset or worsening of existing restless leg syndrome has been reported in adults.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Vitamin D: May decrease serum vitamin D. Monitor serum 25(OH)D levels; supplement with cholecalciferol or ergocalciferol to maintain age-based normal range. Do NOT administer active vitamin D analogs during burosumab treatment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous [preservative free]:

Crysvita: Burosumab-twza 10 mg/mL (1 mL); Burosumab-twza 20 mg/mL (1 mL); Burosumab-twza 30 mg/mL (1 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (Crysvita Subcutaneous)

10 mg/mL (per mL): $5,341.74

20 mg/mL (per mL): $10,683.49

30 mg/mL (per mL): $16,025.23

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Subcutaneous:

Crysvita: Burosumab-twza 10 mg/mL (1 mL); Burosumab-twza 20 mg/mL (1 mL); Burosumab-twza 30 mg/mL (1 mL) [contains polysorbate 80]

Administration: Adult

Note: The product is available in multiple concentrations; verify appropriate product selection for dose. Should be administered by a health care provider.

SUBQ: Administer SUBQ into the upper thighs, any quadrant of abdomen, buttocks, or upper arms. Contents from 2 vials may be combined; however, the maximum volume per injection site is 1.5 mL. Administer each injection at a different anatomic location than a previous injection. Avoid areas where the skin is tender, bruised, red, hard, or not intact, or where there are scars or moles.

Administration: Pediatric

Note: The product is available in multiple concentrations; verify appropriate product selection for dose. Should be administered by a health care provider. Doses may be administered 3 days on either side of a scheduled treatment date to avoid missed dosing. If missed dose falls outside of 3-day window, administer as soon as possible at prescribed dose.

Parenteral: SubQ: Administer undiluted SubQ in upper arms, upper thighs, buttocks, or any quadrant of the abdomen; rotate injection sites with each injection. Avoid injection sites where skin is tender, bruised, red, hard, not intact, or areas with moles or scars. The maximum SubQ volume per injection site is 1.5 mL; larger dose volumes need to be split between 2 injection sites. Inspect vial prior to use; do not use if solution is discolored, cloudy, or contains particulate matter.

Use: Labeled Indications

Osteomalacia, tumor-induced: Treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in pediatric patients ≥2 years of age and adults.

X-linked hypophosphatemia: Treatment of X-linked hypophosphatemia in pediatric patients ≥6 months of age and adults.

Medication Safety Issues
Sound-alike/look-alike issues:

Burosumab may be confused with belimumab, denosumab.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its lists of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Phosphate Supplements: May enhance the adverse/toxic effect of Burosumab. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of Burosumab. Risk X: Avoid combination

Pregnancy Considerations

Burosumab is a human IgG monoclonal antibody and may be transferred across the placenta. Maternal serum phosphorus concentrations should be monitored.

Health care providers are encouraged to report exposures of burosumab during pregnancy to the manufacturer Adverse Event reporting line (888-756-8657).

Breastfeeding Considerations

It is not known if burosumab is present in breast milk. However, burosumab is an IgG monoclonal antibody and maternal IgG immunoglobulins are excreted in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Signs/symptoms of hypersensitivity or injection-site reaction; serum 25-hydroxyvitamin D (25(OH)D) levels.

Serum phosphorus:

Children and adolescents: Evaluate fasting serum phosphorus every 4 weeks for first 12 weeks of therapy and as appropriate thereafter (eg, after dosing adjustments).

Adults: Evaluate fasting serum phosphorus every 4 weeks, measured 2 weeks postdose, for the first 12 weeks of treatment, after any underlying tumor-related treatment (in tumor-induced osteomalacia), and as appropriate thereafter (eg, after dosing adjustments).

Reference Range

Adult patients:

Note: Reference ranges may vary depending on the laboratory.

Fasting serum phosphorus: 3 to 4.5 mg/dL (SI: 1 to 1.5 mmol/L).

Pediatric patients:

Fasting serum phosphorus: 3.1 to 6.2 mg/dL (SI: 1 to 2 mmol/L) (ASPEN [Corkins 2015]); normal ranges are higher in younger patients. In clinical trials of children 5 to 12 years, a target range of 3.5 to 4.5 mg/dL (SI: 1.1 to 1.5 mmol/L) was used (Carpenter 2018).

Fasting serum phosphorus (Kliegman 2020):

1 to 3 years: 3.8 to 6.5 mg/dL (SI: 1.2 to 2.1 mmol/L).

4 to 11 years: 3.7 to 5.6 mg/dL (SI: 1.2 to 1.8 mmol/L).

12 to 15 years: 2.9 to 5.4 mg/dL (SI: 0.9 to 1.7 mmol/L).

16 to 19 years: 2.7 to 4.7 mg/dL (SI: 0.9 to 1.5 mmol/L).

Mechanism of Action

Burosumab binds to and inhibits the activity of fibroblast growth factor 23, thereby restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 8 L

Metabolism: Degraded into small peptides and amino acids via catabolic pathways

Half-life elimination: ~19 days

Time to peak: 8 to 11 days

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Clearance and volume of distribution of burosumab increases with body weight.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Crysvita;
  • (AU) Australia: Crysvita;
  • (BE) Belgium: Crysvita;
  • (BG) Bulgaria: Crysvita;
  • (BR) Brazil: Crysvita;
  • (CO) Colombia: Crysvita;
  • (CZ) Czech Republic: Crysvita;
  • (EE) Estonia: Crysvita;
  • (ES) Spain: Crysvita;
  • (FI) Finland: Crysvita;
  • (HU) Hungary: Crysvita;
  • (IE) Ireland: Crysvita;
  • (IT) Italy: Crysvita;
  • (JP) Japan: Crysvita;
  • (KW) Kuwait: Crysvita;
  • (LV) Latvia: Crysvita;
  • (MX) Mexico: Crysvita;
  • (NL) Netherlands: Crysvita;
  • (NO) Norway: Crysvita;
  • (PL) Poland: Crysvita;
  • (PR) Puerto Rico: Crysvita;
  • (PT) Portugal: Crysvita;
  • (QA) Qatar: Crysvita;
  • (RO) Romania: Crysvita;
  • (RU) Russian Federation: Crysvita;
  • (SA) Saudi Arabia: Crysvita;
  • (SE) Sweden: Crysvita;
  • (SI) Slovenia: Crysvita;
  • (SK) Slovakia: Crysvita
  1. Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Carpenter TO, Whyte MP, Imel EA, et al. Burosumab therapy in children with X-Linked hypophosphatemia. N Engl J Med. 2018;378(21):1987-1998. [PubMed 29791829]
  3. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
  4. Corkins MR, Balint J, Bobo E, et al, eds. The A.S.P.E.N Pediatric Nutrition Support Core Curriculum. 2nd ed. Silver Spring: MD: American Society of Parenteral and Enteral Nutrition, 2015.
  5. Crysvita (burosumab-twza) [prescribing information]. Princeton, NJ: Kyowa Kirin Inc; March 2023.
  6. Crysvita (burosumab-twza) [Canadian product monograph]. Bedminster, NJ: Kyowa Kirin Inc; February 2022.
  7. Imel EA, Zhang X, Ruppe MD, et al. Prolonged correction of serum phosphorus in adults with X-linked hypophosphatemia using monthly doses of KRN23. J Clin Endocrinol Metab. 2015;100(7):2565-2573. doi:10.1210/jc.2015-1551 [PubMed 25919461]
  8. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. doi:10.1034/j.1600-0536.2002.4705104.x [PubMed 12534540]
  9. Kliegman RM and St. Geme J, eds. Nelson Textbook of Pediatrics. 21st ed. Philadelphia, PA: Saunders Elsevier; 2020.
  10. Lamb YN. Burosumab: First global approval. Drugs. 2018;78(6):707-714. [PubMed 29679282]
  11. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  12. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. doi:10.1016/s0140-6736(95)90963-x [PubMed 7746084]
Topic 117667 Version 87.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟