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Pasireotide

Pharmaceutical drug

Pharmaceutical drug

| Drugs.com =

| elimination_half-life =

Pasireotide, sold under the brand name Signifor, is an orphan drug approved in the United States and the European Union for the treatment of Cushing's disease in patients who fail or are ineligible for surgical therapy. 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.

Pasireotide was approved for Cushing's disease by the European Medicines Agency (EMA) in April 2012 and by the U.S. Food and Drug Administration (FDA) in December 2012.

Pasireotide LAR (the long-acting-release formulation) was approved by the FDA for treatment of acromegaly in December 2014, and had been approved for this indication by the EMA in September 2014.

References

References

  1. (24 December 1999). "Drug Approval Package: Signifor (pasireotide) Injection NDA #200677".
  2. (17 September 2018). "Signifor EPAR".
  3. "Summary of Product Characteristics: Signifor". European Medicines Agency.
  4. (24 December 1999). "Pasireotide Orphan Drug Designation and Approval".
  5. (17 September 2018). "EU/3/09/671".
  6. (October 2010). "Treatment of Cushing disease: overview and recent findings". Therapeutics and Clinical Risk Management.
  7. (15 January 2020). "Signifor- pasireotide injection".
  8. (17 December 2019). "Signifor LAR- pasireotide kit".
  9. "EMEA Approval for Pasireotide".
  10. "FDA Approves Pasireotide for Cushing's Disease".
  11. (1 March 2016). "Signifor LAR (pasireotide) for injectable suspension".
  12. Tucker, Miriam E. (17 December 2014). "FDA Approves Pasireotide for Treating Acromegaly". Medscape.
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