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 across a broad range of surgical procedures2,3

Real-world experience

RECOTHROM has been used in over 5 million patients, including 400,000+ pediatric patients, in the United States and Canada since 2008.4,5

A wide range of application methods2

RECOTHROM reduces the need to keep multiple products on formulary

RECOTHROM can be:

Applying RECOTHROM® Thrombin topical (Recombinant) with absorbable gelatin sponge Absorbable gelatin sponge
Applying RECOTHROM® Thrombin topical (Recombinant) with absorbable gelatin sponge powder Mixed with absorbable gelatin sponge powder
Applying RECOTHROM® Thrombin topical (Recombinant) with spray pump Spray pump
Applying RECOTHROM® Thrombin topical (Recombinant) with syringe-tip sprayer Syringe-tip sprayer

For topical use only. DO NOT INJECT directly into the circulatory system.

The recombinant difference

Recombinant manufacturing allows for the consistent production of therapeutic proteins as alternatives to products derived from human or animal plasma.6

The process used to manufacture RECOTHROM does not employ additives of human or animal origin.2

In clinical trials, RECOTHROM has been used in patients with or without preexisting bovine or recombinant human thrombin antibodies.7,8

RECOTHROM manufacturing process9

RECOTHROM® Thrombin topical (Recombinant) manufacturing process

CHO, Chinese hamster ovary.

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. 4. US Department of Health and Human Services. Memorandum, FDA; Subject: Pediatric Safety and Utilization Review for the Pediatric Advisory Committee (PAC) Meeting — STN 125248. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM461217.pdf. Accessed March 28, 2016. 5. Data on file. Mallinckrodt Hospital Products, Inc. 6. de Mora F, Torres R. Biotechnology-derived medicines: what are they? A pharmacological and a historical perspective. J Gen Med. 2010;7(2):145-157. 7. 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. 8. Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA. A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009;209(1):68-74. 9. Bishop PD, Lewis KB, Schultz J, Walker KM. Comparison of recombinant human thrombin and plasma-derived human α-thrombin. Semin Thromb Hemost. 2006;32(suppl 1):86-97.