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.

Safety profile

Patients with common adverse events2

RECOTHROM vs bovine thrombin: Patients with common adverse events (Chapman)e

Phase 3 study: Overall incidence of adverse events (AEs) was similar between patients in the RECOTHROM group and those in the bovine thrombin group2

  • The most commonly reported AEs observed for RECOTHROM and bovine thrombin, respectively, were incision site complication (63%, 63%), procedural pain (29%, 34%), and nausea (28%, 35%)

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).2

Most commonly reported adverse events with RECOTHROM3

Most commonly reported adverse events with RECOTHROM (Singla 2012)

Pooled analysis of results from 10 clinical trials: AEs were mild or moderate in the majority of patients treated with RECOTHROM3

  • In the 644 patients included in this analysis, the most commonly reported AEs were incision site pain (47%), procedural pain (33%), and nausea (26%)

Singla et al: Safety observations were pooled and analyzed from 10 completed trials in which RECOTHROM was applied during a single surgical procedure directly, with an absorbable gelatin sponge, or via spray application.3

Antibody formation

Antibody formation to products2,4,a

RECOTHROM vs bovine thrombin: Antibody formation to products (Chapman)

a Antibody formation at day 29 defined as seroconversion or an increase in antibody titer ≥1.0 unit (≥10-fold) from baseline.

Phase 3 study: 1.5% of patients receiving RECOTHROM developed antiproduct antibodies, compared with 21.5% of patients receiving bovine thrombin2

  • This study was not designed or powered to detect an association between antibody formation and adverse clinical outcomes4
  • Overall incidence of AEs was similar between treatment groups2

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).2

Pooled analysis of results from 10 clinical trials: 0.8% of evaluable patients (n=5/609) developed nonpathogenic antibodies to RECOTHROM3

Singla et al: Antibody development observations were pooled and analyzed from 10 completed trials in which RECOTHROM was applied during a single surgical procedure directly, with an absorbable gelatin sponge, or via spray application. Blood samples were collected before the procedure and at day 29 for immunogenicity analyses.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. 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. 3. Singla NK, Foster KN, Alexander WA, Pribble JP. Safety and immunogenicity of recombinant human thrombin: a pooled analysis of results from 10 clinical trials. Pharmacotherapy. 2012;32(11):998-1005. 4. RECOTHROM [package insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016.