Chemistry:Pasireotide
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| Trade names | Signifor, Signifor LAR |
| Other names | SOM230 |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Subcutaneous injection, intramuscular injection |
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| Formula | C58H66N10O9 |
| Molar mass | 1047.227 g·mol−1 |
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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.
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
- ↑ 1.0 1.1 "Drug Approval Package: Signifor (pasireotide) Injection NDA #200677". 24 December 1999. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/200677Orig1s000TOC.cfm.
- ↑ 2.0 2.1 2.2 2.3 "Signifor EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/signifor. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Summary of Product Characteristics: Signifor". European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002052/WC500128056.pdf.
- ↑ "Pasireotide Orphan Drug Designation and Approval". 24 December 1999. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=288709.
- ↑ "EU/3/09/671". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu309671. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "Treatment of Cushing disease: overview and recent findings". Therapeutics and Clinical Risk Management 6: 505–16. October 2010. doi:10.2147/TCRM.S12952. PMID 21063461.
- ↑ "Signifor- pasireotide injection". 15 January 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=442f0d9d-5c7d-4b81-b329-d71be8cf2be2.
- ↑ "Signifor LAR- pasireotide kit". 17 December 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5504116c-d531-4d47-b160-41c6671d52aa.
- ↑ EMEA Approval for Pasireotide
- ↑ "FDA Approves Pasireotide for Cushing's Disease". http://www.medscape.com/viewarticle/776273.
- ↑ "Signifor LAR (pasireotide) for injectable suspension". 1 March 2016. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.cfm.
- ↑ Tucker, Miriam E (17 December 2014). "FDA Approves Pasireotide for Treating Acromegaly". Medscape. http://www.medscape.com/viewarticle/836728.
External links
- "Pasireotide". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/pasireotide.
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