drotrecogin alpha (Xigris); recombinant protein C, activated
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Introduction
Tradename: Xigris
Withdrawn from US Market Oct 2011
Indications
- FDA approved 12/01 for sepsis*
- septic shock requiring vasopressors despite fluid resuscitation
- sepsis-induced ARDS requiring mechanical ventilation with at least two dysfunctional organs[8]
- systemic inflammatory response syndrome
* does NOT improve mortality in low-risk patients with severe sepsis; recommended only for patients with APACHE II scores > 25[5]
* not helpful in children with severe sepsis[6]
Contraindications
Adverse effects
- bleeding, increased risk of serious bleeding[7]
- death in patients with sepsis & baseline bleeding risk factors[7]
Mechanism of action
Notes
Manufacturer: Lilly
More general terms
Additional terms
References
- ↑ Journal Watch 21(8):61, 2001 Bernar et al, NEJM 344:699, 2001 Mathat, NEJM 344:759, 2001
- ↑ Prescriber's Letter 8(12):72 2001
- ↑ Prescriber's Letter 9(1):4 2002
- ↑ Journal Watch 22(23):174, 2002 Warren HS et al, N Engl J Med 347:1027, 2002 Siegel JP, N Engl J Med 347:1030, 2002 Manns BJ et al, N Engl J Med 347:993, 2002
- ↑ 5.0 5.1 Abraham E, Laterre PF, Garg R, Levy H, Talwar D, Trzaskoma BL, Francois B, Guy JS, Bruckmann M, Rea-Neto A, Rossaint R, Perrotin D, Sablotzki A, Arkins N, Utterback BG, Macias WL; Administration of Drotrecogin Alfa (Activated) in Early Stage Severe Sepsis (ADDRESS) Study Group. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med. 2005 Sep 29;353(13):1332-41. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16192478
- ↑ 6.0 6.1 Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-43. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17350452
- ↑ 7.0 7.1 7.2 FDA Medwatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#Xigris
- ↑ 8.0 8.1 Medical Knowledge Self Assessment Program (MKSAP) 15, American College of Physicians, Philadelphia 2009
- ↑ 9.0 9.1 FDA MedWatch: 10/25/2011 Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit
Marti-Carvajal A, Salanti G, Cardona AF. Human recombinant activated protein C for severe sepsis. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004388 PMID: https://www.ncbi.nlm.nih.gov/pubmed/18254048
Ranieri VM et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012 May 31; 366:2055. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22616830