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RECOTHROM

RECOTHROM Thrombin topical (Recombinant), manufactured using a unique recombinant technology, provides hospitals and their healthcare providers an innovative solution to address less severe intraoperative bleeding across multiple specialties to support natural healing.  
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Recothrom Product

Rapid Hemostasis

95% of patients treated with RECOTHROM achieved hemostasis within 10 minutes, comparable to bovine thrombin in a noninferiority study across multiple surgical specialties .1,2

Recothrom Product

A Convenient Solution

RECOTHROM can be stored from 2-25° C, eliminating the need for refrigeration.  RECOTHROM is also stable at room temperature for 24 hours after reconstitution.  Discard reconstituted solution after 24 hours and do not freeze.

Additional Product Benefits

Low Antiproduct Antibody Formation

A phase 3 study showed that 1.5% of patients receiving RECOTHROM developed antiproduct antibodies, compared with 21.5% of patients receiving bovine thrombin.

 

This study was not designed or powered to detect an association between antibody formation and adverse clinical outcomes. The overall incidence of AEs was similar between treatment groups1.

Versatile Patient Applications


RECOTHROM is the only topical thrombin approved for use in both adult and pediatric patients 1 month of age or older.

Versatile Surgical Applications


Proven efficacy across broad surgical specialties. RECOTHROM may be applied with absorbable gelatin sponge (USP), absorbable gelatin sponge powder (USP), spray pump, or syringe-tip sprayer.

INDICATIONS AND IMPORTANT RISK INFORMATION

RECOTHROM Thrombin topical (Recombinant) Indication

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.

Please see accompanying full Prescribing Information