ବୁରୋସୁମାବ

ବୁରୋସୁମାବ
Monoclonal antibody
Type	Whole antibody
Source	Human
Target	FGF 23
Clinical data
Pronunciation	bur OH sue mab
Trade names	Crysvita
Synonyms	KRN-23, KRN23, burosumab-twza
AHFS/Drugs.com	monograph
MedlinePlus	a618034
data	EU EMA: yes; US DailyMed: Burosumab;
Pregnancy; category	AU: B3 ; ;
Routes of; administration	Subcutaneous
Legal status
Legal status	AU: S4 (Prescription only) ; UK: POM (Prescription only) ; US: ℞-only ; EU: Rx-only ; ℞ (Prescription only);
Pharmacokinetic data
Elimination half-life	16.4 days
Chemical and physical data
Formula	C6388H9904N1700O2006S46
Molar mass	୧,୪୪,୦୯୦.୧୫ g·mol−1

ବୁରୋସୁମାବ, ବେପାର ନାମ କ୍ରିସୋଭିଟା, ଏକ ଔଷଧ ଯାହା ଏକ୍ସ-ଲିଙ୍କ ହାଇପୋଫସଫାଟେମିଆ ଓ ଅର୍ବୁଦ-ପ୍ରେରିତ ଓଷ୍ଟିଓମାଲାସିଆ ରୋଗର ଚିକିତ୍ସାରେ ଦିଆଯାଏ । ^[୮] ଏହା ୫ ମାସରୁ ଅଧିକ ବୟସ୍କମାନଙ୍କରେ ବ୍ୟବହୃତ ହୋଇପାରେ ।^[୫] ଏହା ଚର୍ମ ତଳେ ଇଞ୍ଜେକସନ ଆକାରରେ ଦିଆଯାଏ ।^[୯]

ସାଧାରଣ ପାର୍ଶ୍ୱ ପ୍ରତିକ୍ରିୟାରେ ଜ୍ୱର, ଇଞ୍ଜେକ୍ସନ୍ ସ୍ଥାନରେ ଯନ୍ତ୍ରଣା, କାଶ, ମୁଣ୍ଡବିନ୍ଧା, ଅସ୍ଥିର ଗୋଡ଼ ସିଣ୍ଡ୍ରୋମ, କାଭିଟି ଏବଂ ଦାନ୍ତର ଆବସେସ୍ ଅନ୍ତର୍ଭୁକ୍ତ ।^[୧୦] ଅନ୍ୟାନ୍ୟ ପାର୍ଶ୍ୱ ପ୍ରତିକ୍ରିୟାରେ ଆଲର୍ଜି ପ୍ରତିକ୍ରିୟା, ଉଚ୍ଚ ଫସଫେଟ୍ ଏବଂ ନେଫ୍ରୋକାଲସିନୋସିସ୍ ଅନ୍ତର୍ଭୁକ୍ତ ହୋଇପାରେ ।^[୧୦] ଗର୍ଭାବସ୍ଥାରେ ସୁରକ୍ଷା ଅସ୍ପଷ୍ଟ ଅଟେ ।^[୧୦] ଏହା ଏକ ମୋନୋକ୍ଲୋନାଲ ଆଣ୍ଟିବଡି ଯାହା ପ୍ରୋଟିନ୍ ଏଫଜିଏଫ୨୩କୁ ବାନ୍ଧେ ଓ ଅବରୋଧ କରେ ଏବଂ ବୃକ୍‌କ‌କୁ ଫସଫେଟର ପୁନଃ ଅବଶୋଷଣ କରିବାକୁ ଅନୁମତି ଦିଏ ।^[୧୧]

ଏହା ୨୦୧୮ ମସିହାରେ ଆମେରିକା ଏବଂ ୟୁରୋପରେ ଡାକ୍ତରୀ ବ୍ୟବହାର ପାଇଁ ଅନୁମୋଦନ କରାଯାଇଥିଲା । ^[୮] ^[୧୨] ଯୁକ୍ତରାଷ୍ଟ୍ରରେ ଏହାର ୩୦ ମିଗ୍ରାର ମୂଲ୍ୟ ୨୦୨୨ରେ ୧୨୨୦୦ ଦଲାର ଥିଲା ।^[୧୩]

ଆଧାର

↑ ^୧.୦ ^୧.୧ "Crysvita". Therapeutic Goods Administration (TGA). 17 September 2021. Archived from the original on 17 September 2021. Retrieved 17 September 2021.
↑ "Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial". Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.
↑ "Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial" (PDF). Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.
↑ "Crysvita 10 mg solution for injection - Summary of Product Characteristics (SmPC)". (emc). 20 April 2020. Archived from the original on 21 June 2020. Retrieved 19 June 2020.
↑ ^୫.୦ ^୫.୧ "Crysvita- burosumab injection". DailyMed. Archived from the original on 17 September 2021. Retrieved 17 September 2021.
↑ "Drug Approval Package: Crysvita (burosumab-twza)". U.S. Food and Drug Administration (FDA). 15 May 2018. Archived from the original on 28 February 2020. Retrieved 28 February 2020.
↑ Zhang X, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Ito T, et al. (February 2016). "Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia". Journal of Clinical Pharmacology. 56 (2): 176–85. doi:10.1002/jcph.570. PMC 5042055. PMID 26073451.
↑ ^୮.୦ ^୮.୧ "Crysvita- burosumab injection". DailyMed. Archived from the original on 17 September 2021. Retrieved 17 September 2021.
↑ "Burosumab". SPS - Specialist Pharmacy Service. 30 November 2016. Archived from the original on 22 June 2020. Retrieved 12 January 2022.
↑ ^୧୦.୦ ^୧୦.୧ ^୧୦.୨ ଆଧାର ଭୁଲ: ଅଚଳ <ref> ଚିହ୍ନ; PI2022 ନାମରେ ଥିବା ଆଧାର ଭିତରେ କିଛି ଲେଖା ନାହିଁ ।
↑ "Crysvita EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 25 July 2021. Retrieved 1 March 2020.
↑ "Crysvita Prices, Coupons & Patient Assistance Programs". Drugs.com (in ଇଂରାଜୀ). Archived from the original on 14 April 2021. Retrieved 12 January 2022.
↑ "Crysvita EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 25 July 2021. Retrieved 1 March 2020.

[autogen1-1] ୧.୦ ^୧.୧ "Crysvita". Therapeutic Goods Administration (TGA). 17 September 2021. Archived from the original on 17 September 2021. Retrieved 17 September 2021.

[2] "Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial". Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.

[3] "Crysvita burosumab 10 mg/mL solution for injection in a 5 mL vial" (PDF). Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.

[4] "Crysvita 10 mg solution for injection - Summary of Product Characteristics (SmPC)". (emc). 20 April 2020. Archived from the original on 21 June 2020. Retrieved 19 June 2020.

[autogen2-5] ୫.୦ ^୫.୧ "Crysvita- burosumab injection". DailyMed. Archived from the original on 17 September 2021. Retrieved 17 September 2021.

[6] "Drug Approval Package: Crysvita (burosumab-twza)". U.S. Food and Drug Administration (FDA). 15 May 2018. Archived from the original on 28 February 2020. Retrieved 28 February 2020.

[7] Zhang X, Imel EA, Ruppe MD, Weber TJ, Klausner MA, Ito T, et al. (February 2016). "Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia". Journal of Clinical Pharmacology. 56 (2): 176–85. doi:10.1002/jcph.570. PMC 5042055. PMID 26073451.

[autogen3-8] ୮.୦ ^୮.୧ "Crysvita- burosumab injection". DailyMed. Archived from the original on 17 September 2021. Retrieved 17 September 2021.

[SP2022-9] "Burosumab". SPS - Specialist Pharmacy Service. 30 November 2016. Archived from the original on 22 June 2020. Retrieved 12 January 2022.

[PI2022-10] ୧୦.୦ ^୧୦.୧ ^୧୦.୨ ଆଧାର ଭୁଲ: ଅଚଳ <ref> ଚିହ୍ନ; PI2022 ନାମରେ ଥିବା ଆଧାର ଭିତରେ କିଛି ଲେଖା ନାହିଁ ।

[EPAR20223-11] "Crysvita EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 25 July 2021. Retrieved 1 March 2020.

[12] "Crysvita Prices, Coupons & Patient Assistance Programs". Drugs.com (in ଇଂରାଜୀ). Archived from the original on 14 April 2021. Retrieved 12 January 2022.

[EPAR2022-13] "Crysvita EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 25 July 2021. Retrieved 1 March 2020.

[୧]

[୨]

[୩]

[୪]

[୫]

[୬]

[୭]

[୮]

[୯]

[୧୦]

[୧୧]

[୧୨]

[୧୩]