Mallinckrodt Hemostat SolutionsMallinckrodt Hemostat Solutions

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Indications and Usage

RECOTHROM® Thrombin topical (Recombinant) is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

Proven as effective as bovine thrombin2,3

Hemostasis over time—cumulative incidence2

RECOTHROM vs bovine thrombin: Cumulative incidence of hemostasis (Chapman)

a P value was not significant at any time point.

Phase 3 study: 95% of patients receiving RECOTHROM achieved hemostasis within 10 minutes, comparable to bovine thrombin in a noninferiority study2,3

Chapman et al: In a randomized, double-blind phase 3 study, 401 patients at 34 US study sites undergoing spinal surgery, hepatic resection, peripheral arterial bypass, or arteriovenous graft for hemodialysis access received either RECOTHROM (1000 units/mL) or bovine thrombin (1000 units/mL).3

Indications and Usage

RECOTHROM® Thrombin topical (Recombinant) is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.

Important Risk Information

Contraindications

  • Do not inject directly into the circulatory system.
  • Do not use for the treatment of massive or brisk arterial bleeding.
  • Do not administer to patients with a history of hypersensitivity to RECOTHROM or any components of RECOTHROM.
  • Do not use in patients with known hypersensitivity to hamster proteins.

Warnings and Precautions

  • For topical use only. DO NOT INJECT.
  • RECOTHROM may cause thrombosis if it enters the circulatory system.
  • Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM is produced in a genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins.

Adverse Reactions

  • Thromboembolic adverse reactions were reported in 6% of surgical patients treated with RECOTHROM in all completed clinical trials.
  • Antibody formation to RECOTHROM occurred in <1% of patients. None of the antibodies detected neutralized native human thrombin.

Use In Specific Populations

  • Pregnancy Category C. RECOTHROM should be given to a pregnant woman only if clearly needed.
  • Pediatric Use: Safety and efficacy have not been established in neonates.
  • Geriatric Use: Of 644 patients in clinical studies of RECOTHROM, 36% (n=232/644) were ≥65 years old and 15% (n=95/644) were ≥75 years old. No differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the Full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products, Inc. at 1-800-778-7898 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Mallinckrodt completes acquisition of three commercial-stage, global specialty hemostasis brands from The Medicines Company [news release]. Chesterfield, UK: Mallinckrodt Pharmaceuticals; February 1, 2016. http://www.mallinckrodt.com/about/news-and-media/2134017. Accessed April 6, 2016. 2. RECOTHROM [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016. 3. Chapman WC, Singla N, Genyk Y, et al. 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.