ଡାରୋଲୁଟାମାଇଡ

ଡାରୋଲୁଟାମାଇଡ
Clinical data
Trade names	Nubeqa
Synonyms	Darramamide, ODM-201, BAY-1841788
AHFS/Drugs.com	monograph
MedlinePlus	a619045
data	EU EMA: yes; US DailyMed: Darolutamide;
Pregnancy; category	AU: X (High risk) ; US: N (Not classified yet) ; ;
Routes of; administration	By mouth
Legal status
Legal status	AU: S4 (Prescription only) ; US: ℞-only ; EU: Rx-only ;
Pharmacokinetic data
Bioavailability	≤30%
Protein binding	Darolutamide: 92%; Ketodarolutamide: 99.8%
Metabolism	Dehydrogenation (CYP3A4), glucuronidation (UGT1A9, UGT1A1)
Metabolites	Ketodarolutamide
Elimination half-life	16–20 hours
Excretion	Urine: 63.4%; Feces: 32.4%
Identifiers
	IUPAC name N-((S)-1-(3-(3-Chloro-4-cyanophenyl)-1H-pyrazol-1-yl)propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide;
ECHA InfoCard	100.264.885
Chemical and physical data
Formula	C19H19ClN6O2
Molar mass	୩୯୮.୮୫ g·mol−1
3D model (JSmol)	Interactive image;
	SMILES C[C@@H](Cn1ccc(n1)c2ccc(c(c2)Cl)C#N)NC(=O)c3cc([nH]n3)C(C)O;
	InChI InChI=1S/C19H19ClN6O2/c1-11(22-19(28)18-8-17(12(2)27)23-24-18)10-26-6-5-16(25-26)13-3-4-14(9-21)15(20)7-13/h3-8,11-12,27H,10H2,1-2H3,(H,22,28)(H,23,24)/t11-,12?/m0/s1; Key:BLIJXOOIHRSQRB-PXYINDEMSA-N;
(verify)

ଡାରୋଲୁଟାମାଇଡ (ଇଂରାଜୀ ଭାଷାରେ Darolutamide), ନ୍ୟୁବେକା ଏହାର ଏକ ବିକ୍ରୟ ନାମ, ହେଉଛି ପ୍ରୋସ୍ଟେଟ କର୍କଟ ରୋଗର ଚିକିତ୍ସା ପାଇଁ ବ୍ୟବହୃତ ଏକ ଔଷଧ ।^[୪] ^[୩] ନିର୍ଦ୍ଦିଷ୍ଟ ଭାବରେ ଏହା ଅସ୍ତ୍ରୋପଚାର କିମ୍ବା ମେଡିକାଲ ଜନଦନାଶନ (ଖାସୁ) ସହିତ ଅଣ-ମେଟାଷ୍ଟାଟିକ୍ କାଷ୍ଟ୍ରେସନ୍-ପ୍ରତିରୋଧକ ପ୍ରୋଷ୍ଟେଟ୍ କର୍କଟ (nmCRPC) ପାଇଁ ବ୍ୟବହୃତ ହୁଏ ।^[୪] ଏହି ଔଷଧ ଖାଦ୍ୟ ସହିତ ଦିନ‌କୁ ଦୁଇଥର ପାଟିରେ ଦିଆଯାଏ ।^[୪]

ସାଧାରଣ ପାର୍ଶ୍ୱ ପ୍ରତିକ୍ରିୟାରେ କ୍ଳାନ୍ତି, ବାହୁ ଏବଂ ଗୋଡରେ ଯନ୍ତ୍ରଣା, ଏବଂ ରାସ ହୋଇପାରେ ।^[୪] ଅନ୍ୟ ପାର୍ଶ୍ୱ ପ୍ରତିକ୍ରିୟାରେ ଅନୁର୍ବରତା ଏବଂ ସ୍ୱଳ୍ପ ଶ୍ୱେତ ରକ୍ତ କଣିକା ହୋଇପାରେ ।^[୬] ଗର୍ଭାବସ୍ଥାରେ ପୁରୁଷ କିମ୍ବା ମହିଳାଙ୍କଦ୍ୱାରା ଏହା ବ୍ୟବହାର କଲେ ଶିଶୁର କ୍ଷତି ହୋଇପାରେ ।^[୪] ଏହା ଏକ ନନ୍-ସ୍ଟିରଏଡାଲ୍ ଆଣ୍ଟିଆଣ୍ଡ୍ରୋଜେନ୍ (NSAA); ଆଣ୍ଡ୍ରୋଜେନ ସ‌ହିତ ଆଣ୍ଡ୍ରୋଜେନ୍ ରିସେପ୍ଟର ବାନ୍ଧିବାରେ ପ୍ରତିରୋଧ କରି ଏହା କାର୍ଯ୍ୟକ୍ଷମ ହୁଏ ।^[୬]

୨୦୧୧ ମସିହାରେ ଡାରୋଲୁଟାମାଇଡ ପ୍ୟାଟେଣ୍ଟ୍ ହୋଇଥିଲା ।^[୭] ୨୦୧୯ ମସିହାରେ ଯୁକ୍ତରାଷ୍ଟ୍ରରେ ଏବଂ ୨୦୨୦ରେ ୟୁରୋପ ଏବଂ ଅଷ୍ଟ୍ରେଲିଆରେ ଚିକିତ୍ସା କ୍ଷେତ୍ରରେ ବ୍ୟବହାର ପାଇଁ ଏହାକୁ ଅନୁମୋଦନ କରାଯାଇଥିଲା ।^[୪] ^[୩] ^[୮] ଯୁକ୍ତରାଜ୍ୟରେ ୨୦୨୧ ସୁଦ୍ଧା ୪ ସପ୍ତାହର ଔଷଧ ଖର୍ଚ୍ଚ ପ୍ରାୟ ୪୦୦୦ ପାଉଣ୍ଡ ଥିଲା ।^[୯] ଯୁକ୍ତରାଷ୍ଟ୍ରରେ ଏହି ପରିମାଣର ଖର୍ଚ୍ଚ ପ୍ରାୟ ୧୧୦୦୦ ଡଲାର ଅଟେ ।^[୧୦]

ଆଧାର

↑ "Darolutamide (Nubeqa) Use During Pregnancy". Drugs.com. 17 September 2019. Archived from the original on 3 December 2020. Retrieved 16 August 2020.
↑ "Nubeqa Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 4 March 2020. Archived from the original on 28 August 2021. Retrieved 16 August 2020.
↑ ^୩.୦ ^୩.୧ ^୩.୨ "Nubeqa EPAR". European Medicines Agency (EMA). 29 January 2020. Archived from the original on 29 October 2020. Retrieved 16 August 2020.
↑ ^୪.୦୦ ^୪.୦୧ ^୪.୦୨ ^୪.୦୩ ^୪.୦୪ ^୪.୦୫ ^୪.୦୬ ^୪.୦୭ ^୪.୦୮ ^୪.୦୯ ^୪.୧୦ ^୪.୧୧ ^୪.୧୨ ^୪.୧୩ ^୪.୧୪ "Nubeqa- darolutamide tablet, film coated". DailyMed. 31 July 2019. Archived from the original on 17 October 2020. Retrieved 22 November 2019.
↑ ^୫.୦ ^୫.୧ Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, et al. (August 2014). "Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial" (PDF). The Lancet. Oncology. 15 (9): 975–85. doi:10.1016/S1470-2045(14)70240-2. PMID 24974051. Archived (PDF) from the original on 1 December 2020. Retrieved 9 August 2021.
↑ ^୬.୦ ^୬.୧ "Darolutamide Monograph for Professionals". Drugs.com (in ଇଂରାଜୀ). Archived from the original on 23 November 2019. Retrieved 28 December 2021.
↑ "Androgen receptor modulating compounds". Archived from the original on 3 September 2019. Retrieved 28 December 2021.
↑ "AusPAR: Darolutamide". Therapeutic Goods Administration (TGA). 3 August 2020. Archived from the original on 21 September 2020. Retrieved 22 September 2020.
↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 991. ISBN 978-0857114105.
↑ "Darolutamide Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 28 December 2021.

[Drugs.com_pregnancy-1] "Darolutamide (Nubeqa) Use During Pregnancy". Drugs.com. 17 September 2019. Archived from the original on 3 December 2020. Retrieved 16 August 2020.

[Nubeqa_APMDS-2] "Nubeqa Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 4 March 2020. Archived from the original on 28 August 2021. Retrieved 16 August 2020.

[EPAR2021-3] ୩.୦ ^୩.୧ ^୩.୨ "Nubeqa EPAR". European Medicines Agency (EMA). 29 January 2020. Archived from the original on 29 October 2020. Retrieved 16 August 2020.

[PI2021-4] ୪.୦୦ ^୪.୦୧ ^୪.୦୨ ^୪.୦୩ ^୪.୦୪ ^୪.୦୫ ^୪.୦୬ ^୪.୦୭ ^୪.୦୮ ^୪.୦୯ ^୪.୧୦ ^୪.୧୧ ^୪.୧୨ ^୪.୧୩ ^୪.୧୪ "Nubeqa- darolutamide tablet, film coated". DailyMed. 31 July 2019. Archived from the original on 17 October 2020. Retrieved 22 November 2019.

[FizaziMassard2014-5] ୫.୦ ^୫.୧ Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, et al. (August 2014). "Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial" (PDF). The Lancet. Oncology. 15 (9): 975–85. doi:10.1016/S1470-2045(14)70240-2. PMID 24974051. Archived (PDF) from the original on 1 December 2020. Retrieved 9 August 2021.

[AHFS2021-6] ୬.୦ ^୬.୧ "Darolutamide Monograph for Professionals". Drugs.com (in ଇଂରାଜୀ). Archived from the original on 23 November 2019. Retrieved 28 December 2021.

[Patent2011-7] "Androgen receptor modulating compounds". Archived from the original on 3 September 2019. Retrieved 28 December 2021.

[8] "AusPAR: Darolutamide". Therapeutic Goods Administration (TGA). 3 August 2020. Archived from the original on 21 September 2020. Retrieved 22 September 2020.

[BNF81-9] BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 991. ISBN 978-0857114105.

[10] "Darolutamide Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 28 December 2021.

[୪]

[୩]

[୧]

[୨]

[୫]

[୬]

[୭]

[୮]

[୯]

[୧୦]