Thrombin,Topical (Recombinant)

Abstract

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to your Pharmacy & Therapeutics Committee. Subscribers also receive monthly 1-page summary monographs on the agents that are useful for agendas and pharmacy/nursing inservices. A comprehensive target drug utilization evaluation (DUE) is also provided each month. With a subscription, the monographs are sent to you in print and are also available online. Monographs can be customized to meet the needs of your facility. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X.

Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800-322-4349. The July 2008 monograph topics are on subcutaneous methylnaltrexone bromide, certolizumab pegol, regadenoson injection, olopatadine hydrochloride nasal spray, and triamcinolone acetonide injectable suspension. The DUE is on subcutaneous methylnaltrexone bromide.

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References

Recothrom [package insert]. Seattle, WA: ZymoGenetics Inc; 2008.

Evithrom [package insert]. Somerville, NJ: J&J Wound Management; 2007.

Thrombin-JMI [package insert]. Bristol, VA: Jones Pharma Incorporated; 2007.

Bishop

, Lawson

Recombinant biologics for treatment of bleeding disorders. Nat Rev Drug Discov. 2004; 3(8): 684–694.

Bishop

Protein characterization of recombinant human thrombin and demonstration of efficacy in models of surgical bleeding [abstract]. Blood. 2003; 102(11, pt 2): 89B.

Chapman

W.C.

, Singla

, Genyk

A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007; 205(2): 256–265.

Chapman

W.C.

, Lockstadt

, Singla

, Kafie

F.E.

, Lawson

J.H.

Phase 2, randomized, double-blind, placebo-controlled, multicenter clinical evaluation of recombinant human thrombin in multiple surgical indications. J Thromb Haemost. 2006; 4(9): 2083–2085.

Bishop

P.D.

, Lewis

K.B.

, Schultz

, Walker

K.M.

Comparison of recombinant human thrombin and plasma-derived human alpha-thrombin. Semin Thromb Hemost. 2006; 32(Suppl 1): 86–97.

Rene

, Stamm

M.R.

, Greeff

, Walker

K.M.

, Raymond

, West

R.R.

Recombinant human thrombin does not contain detectable factor V impurities [abstract]. Pharmacotherapy. 2004; 24: 1438.

10.

Visich

J.E.

, Byrnes-Blake

K.A.

, Lewis

K.B.

, Meengs

, Rogge

M.C.

Bioavailability and relative tissue distribution of [125I]-recombinant human thrombin following intravenous or subcutaneous administration to non-human primates. J Thromb Haemost. 2006; 4(9): 1962–1968.

11.

Heffernan

J.K.

, Ponce

R.A.

, Zuckerman

L.A.

Preclinical safety of recombinant human thrombin. Regul Toxicol Pharmacol. 2007; 47(1): 48–58.

12.

Sarfati

M.R.

, DiLorenzo

D.J.

, Kraiss

L.W.

, Galt

Severe coagulopathy following intraoperative use of topical thrombin. Ann Vasc Surg. 2004; 18(3): 349–351.

13.

Schoenecker

J.G.

, Hauck

R.K.

, Mercer

M.C.

, Parker

, Lawson

J.H.

Exposure to topical bovine thrombin during surgery elicits a response against the xenogeneic carbohydrate galactose alpha1-3galactose. J Clin Immunol. 2000; 20(6): 434–444.

14.

Neschis

D.G.

, Heyman

M.R.

, Cheanvechai

, Benjamin

M.E.

, Flinn

W.R.

Coagulopathy as a result of factor V inhibitor after exposure to bovine thrombin. J Vasc Surg. 2002; 35(2): 400–402.

15.

Poynton

A.R.

, Nelson

M.C.

, McCance

S.E.

, Levine

R.L.

, O'Leary

P.F.

Bovine thrombin induces an acquired coagulopathy in sensitized patients undergoing revision spinal surgery: a report of two cases. Spine. 2003; 28(12): E221–E223.

16.

Lawson

J.H.

, Lynn

K.A.

, Vanmatre

R.M.

Antihuman factor V antibodies after use of relatively pure bovine thrombin. Ann Thorac Surg. 2005; 79(3): 1037–1038.

17.

Ortel

T.L.

, Mercer

M.C.

, Thames

E.H.

, Moore

K.D.

, Lawson

J.H.

Immunologic impact and clinical outcomes after surgical exposure to bovine thrombin. Ann Surg. 2001; 233(1): 88–96.

18.

Lawson

J.H.

The clinical use and immunologic impact of thrombin in surgery. Semin Thromb Hemost. 2006; 32(Suppl 1): 98–110.

19.

Heffernan

J.K.

, Wills

, Ponce

R.A.

Nonclinical safety and immunogenicity evaluation of repeated subcutaneous administration of rhThrombin [abstract]. Pharmacotherapy. 2004; 24: 1466.

20.

Malarkey

M.A.

, Epstein

J.S.

Food and Drug Administration/Center for Biologics Evaluation and Research Recthrom product approval information letter. Food and Drug Administration Web site. www.fda.gov/cber/approvltr/recothrom011708L.htm. Published January 17, 2008. Accessed March 11, 2008.