Pasireotide, sold under the brand name Signifor, is an orphan drug approved in the United States[1] and the European Union[2][3] for the treatment of Cushing's disease in patients who fail or are ineligible for surgical therapy.[4][5][6] It was developed by Novartis. Pasireotide is a somatostatinanalog with a 40-fold increased affinity to somatostatin receptor 5 compared to other somatostatin analogs.
The most common side effects include hyperglycaemia (high blood sugar levels), diabetes, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), cholelithiasis (gallstones), injection site reactions, and tiredness.[2][7][8]
Pasireotide LAR (the long-acting-release formulation) was approved by the FDA for treatment of acromegaly in December 2014,[11] and had been approved for this indication by the EMA in September 2014.[2][12]
Referencesedit
^ ab"Drug Approval Package: Signifor (pasireotide) Injection NDA #200677". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 13 May 2020.
pasireotide, sold, under, brand, name, signifor, orphan, drug, approved, united, states, european, union, treatment, cushing, disease, patients, fail, ineligible, surgical, therapy, developed, novartis, somatostatin, analog, with, fold, increased, affinity, so. Pasireotide sold under the brand name Signifor is an orphan drug approved in the United States 1 and the European Union 2 3 for the treatment of Cushing s disease in patients who fail or are ineligible for surgical therapy 4 5 6 It was developed by Novartis Pasireotide is a somatostatin analog with a 40 fold increased affinity to somatostatin receptor 5 compared to other somatostatin analogs PasireotideClinical dataTrade namesSignifor Signifor LAROther namesSOM230AHFS Drugs comMonographLicense dataUS DailyMed PasireotidePregnancycategoryAU B3Routes ofadministrationSubcutaneous injection intramuscular injectionATC codeH01CB05 WHO Legal statusLegal statusUK POM Prescription only US only EU Rx only In general Prescription only IdentifiersIUPAC name 3S 6S 9S 12R 15S 18S 20R 9 4 aminobutyl 3 benzyl 12 1H indol 3 ylmethyl 2 5 8 11 14 17 hexaoxo 15 phenyl 6 4 phenylmethoxyphenyl methyl 1 4 7 10 13 16 hexazabicyclo 16 3 0 henicosan 20 yl N 2 aminoethyl carbamateCAS Number396091 73 9 YPubChem CID9941444IUPHAR BPS2018DrugBankDB06663 NChemSpider8117062 NUNII98H1T17066KEGGD10147 NChEBICHEBI 72312 NECHA InfoCard100 211 883Chemical and physical dataFormulaC 58H 66N 10O 9Molar mass1047 227 g mol 13D model JSmol Interactive imageSMILES C1 C H CN2 C H 1C O N C H C O N C H C O N C H C O N C H C O N C H C2 O CC3 CC CC C3 CC4 CC C C C4 OCC5 CC CC C5 CCCCN CC6 CNC7 CC CC C76 C8 CC CC C8 OC O NCCNInChI InChI 1S C58H66N10O9 c59 27 13 12 22 46 52 69 64 47 30 38 23 25 42 26 24 38 76 36 39 16 6 2 7 17 39 53 70 66 49 31 37 14 4 1 5 15 37 57 74 68 35 43 77 58 75 61 29 28 60 33 50 68 55 72 67 51 40 18 8 3 9 19 40 56 73 65 48 54 71 63 46 32 41 34 62 45 21 11 10 20 44 41 45 h1 11 14 21 23 26 34 43 46 51 62H 12 13 22 27 33 35 36 59 60H2 H 61 75 H 63 71 H 64 69 H 65 73 H 66 70 H 67 72 t43 46 47 48 49 50 51 m1 s1 NKey VMZMNAABQBOLAK DBILLSOUSA N N N Y what is this verify The most common side effects include hyperglycaemia high blood sugar levels diabetes diarrhoea abdominal pain stomach ache nausea feeling sick cholelithiasis gallstones injection site reactions and tiredness 2 7 8 Pasireotide was approved for Cushing s disease by the European Medicines Agency EMA in April 2012 2 9 and by the U S Food and Drug Administration FDA in December 2012 1 10 Pasireotide LAR the long acting release formulation was approved by the FDA for treatment of acromegaly in December 2014 11 and had been approved for this indication by the EMA in September 2014 2 12 References edit a b Drug Approval Package Signifor pasireotide Injection NDA 200677 U S Food and Drug Administration FDA 24 December 1999 Retrieved 13 May 2020 a b c d Signifor EPAR European Medicines Agency EMA 17 September 2018 Retrieved 13 May 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged Summary of Product Characteristics Signifor PDF European Medicines Agency Pasireotide Orphan Drug Designation and Approval U S Food and Drug Administration FDA 24 December 1999 Retrieved 13 May 2020 EU 3 09 671 European Medicines Agency 17 September 2018 Retrieved 13 May 2020 Text was copied from this source which is c European Medicines Agency Reproduction is authorized provided the source is acknowledged Mancini T Porcelli T Giustina A October 2010 Treatment of Cushing disease overview and recent findings Therapeutics and Clinical Risk Management 6 505 16 doi 10 2147 TCRM S12952 PMC 2963160 PMID 21063461 Signifor pasireotide injection DailyMed 15 January 2020 Retrieved 13 May 2020 Signifor LAR pasireotide kit DailyMed 17 December 2019 Retrieved 13 May 2020 EMEA Approval for Pasireotide FDA Approves Pasireotide for Cushing s Disease Signifor LAR pasireotide for injectable suspension U S Food and Drug Administration FDA 1 March 2016 Retrieved 13 May 2020 Tucker ME 17 December 2014 FDA Approves Pasireotide for Treating Acromegaly Medscape Retrieved 2 August 2015 Portal nbsp Medicine nbsp This hormonal preparation article is a stub You can help Wikipedia by expanding it vte Retrieved from https en wikipedia org w index php title Pasireotide amp oldid 1214237360, wikipedia, wiki, book, books, library,
