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CRYSVITA
Overview
What is CRYSVITA?
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. Burosumab-twza is composed of two heavy chain (γ1-chain) molecules and two light chain (κ-chain) molecules. Each heavy chain has an N-linked carbohydrate moiety at asparagine 297 (Asn297). The molecular weight of burosumab-twza determined by mass spectrometry is approximately 147,000.
CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution in a single-dose vial.
Each 1 mL of solution contains 10 mg, 20 mg or 30 mg of burosumab-twza, L-histidine (1.55 mg), L-methionine (1.49 mg), polysorbate 80 (0.5 mg), D-sorbitol (45.91 mg) in Water for Injection, USP. Hydrochloric acid may be used to adjust to a pH of 6.25.
What does CRYSVITA look like?
What are the available doses of CRYSVITA?
Injection: 10 mg/mL, 20 mg/mL, or 30 mg/mL in a single-dose vial ()
What should I talk to my health care provider before I take CRYSVITA?
How should I use CRYSVITA?
CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.
CRYSVITA is administered by subcutaneous injection and should be administered by a healthcare provider.
Discontinue oral phosphate and active vitamin D analogs 1 week prior to initiation of treatment. Fasting serum phosphorus concentration should be below the reference range for age prior to initiation of treatment.
What interacts with CRYSVITA?
Sorry No Records found
What are the warnings of CRYSVITA?
Sorry No Records found
What are the precautions of CRYSVITA?
Sorry No Records found
What are the side effects of CRYSVITA?
Sorry No records found
What should I look out for while using CRYSVITA?
Do not use CRYSVITA with oral phosphate and active vitamin D analogs.
Do not initiate CRYSVITA treatment if serum phosphorus is within or above the normal range for age.
CRYSVITA is contraindicated in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.
What might happen if I take too much CRYSVITA?
There have been no reports of overdose with CRYSVITA. CRYSVITA has been administered in pediatric clinical trials without dose limiting toxicity using doses up to 2 mg/kg body weight with a maximal dose of 90 mg, administered every two weeks. In adult clinical trials, no dose limiting toxicity has been observed using doses up to 1 mg/kg or a maximal total dose of 128 mg every 4 weeks. In non-XLH rabbits and cynomolgus monkeys, ectopic mineralization in multiple tissues and organs was observed at doses of burosumab-twza that resulted in supra-physiologic serum phosphate levels. Adverse effects on bone including reductions in bone mineral density, bone mineralization and bone strength were also observed at exposure greater than human exposure [
].
In case of overdose, it is recommended that serum phosphorus levels, serum calcium levels and renal function be measured immediately and monitored periodically until resolution to normal/baseline levels. In case of hyperphosphatemia, withhold CRYSVITA and initiate appropriate medical treatment.
How should I store and handle CRYSVITA?
CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product. CRYSVITA (burosumab-twza) injection for subcutaneous administration is supplied as a sterile, preservative-free, clear to slightly opalescent and colorless to pale brown-yellow solution. The product is available as one single-dose vial per carton in the following strengths:10 mg/mL (NDC# 69794-102-01)20 mg/mL (NDC# 69794-203-01)30 mg/mL (NDC# 69794-304-01)CRYSVITAvials 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 freezeor shakeCRYSVITA.Do not use CRYSVITA beyond the expiration date stamped on the carton.CRYSVITA vials are single-dose only. Discard any unused product.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
X-linked hypophosphatemia is caused by excess fibroblast growth factor 23 (FGF23) which suppresses renal tubular phosphate reabsorption and the renal production of 1,25 dihydroxy vitamin D. Burosumab-twza binds to and inhibits the biological activity of FGF23 restoring renal phosphate reabsorption and increasing the serum concentration of 1,25 dihydroxy vitamin D.
Non-Clinical Toxicology
Do not use CRYSVITA with oral phosphate and active vitamin D analogs.Do not initiate CRYSVITA treatment if serum phosphorus is within or above the normal range for age.
CRYSVITA is contraindicated in patients with severe renal impairment or end stage renal disease because these conditions are associated with abnormal mineral metabolism.
Nephrotoxicity has been reported following concomitant administration of cephalosporins with aminoglycoside antibacterial drugs or potent diuretics such as furosemide. Renal function should be carefully monitored, especially if higher dosages of the aminoglycosides are to be administered or if therapy is prolonged, because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs. Nephrotoxicity and ototoxicity were not noted when ceftazidime was given alone in clinical trials.
Chloramphenicol has been shown to be antagonistic to beta-lactam antibacterial drugs, including ceftazidime, based on studies and time kill curves with enteric gram-negative bacilli. Due to the possibility of antagonism , particularly when bactericidal activity is desired, this drug combination should be avoided.
In common with other antibacterial drugs, ceftazidime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients with CRYSVITA. Discontinue CRYSVITA if serious hypersensitivity reactions occur and initiate appropriate medical treatment .
The following adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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