Recothrom Thrombin, topical (Recombinant) powder for solution
For Topical Use only
These highlights do not include all of the information needed to use Recothrom safely and effectively. See full prescribing information for Recothrom.
Recothrom Indications and Usage
Recothrom is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. May be used in conjunction with an absorbable gelatin sponge, USP.
Recothrom Dosage and Administration
- For topical use only. DO NOT INJECT
- Reconstitute Recothrom powder with sterile 0.9% sodium chloride injection, USP, yielding a solution containing 1000 IU/mL.
- Apply Recothrom solution directly to bleeding site surface or in conjunction with absorbable gelatin sponge. The amount required depends upon the area of tissue to be treated.
Dosage Forms and Strengths
5000-IU vial of sterile powder for solution
Recothrom 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 known hypersensitivity to Recothrom, any components of Recothrom or hamster proteins.
Warnings and Precautions
- Potential risk of thrombosis if absorbed systemically.
- In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction.
Adverse Reactions
- Adverse events were reported with similar frequency in the two treatment groups. The most common adverse event reported was incision site complication.
- Treatment with Recothrom resulted in a statistically significantly lower incidence of specific anti-product antiboddevelopment. Three of 198 (1.5%, 95% CI; 0 to 4%) of the patients in the Recothrom arm developed specific anti-thrombin product antibodies (one patient also developed anti-CHOhost cell protein antibodies). Forty-three of 200 subjects, (22%, 95% CI; 16 to 28%) in the bovine thrombin arm developed specifiantibodies to bovine thrombin product. None of the antibodies in the Recothrom group neutralized native human thrombin. Antibodies against bovine thrombin product were not testedneutralization of native human thrombin. Development of antibodies in either group did not lead to any as excessive bleeding.
- Limited data (n=6) are available on repeat exposure to Recothrom.
To report SUSPECTED ADVERSE REACTIONS, contact ZymoGenetics, Inc. at 1-888-784-7662, or FDA at 1-800-FDA-1088 and www.fda.gov/medwatch.
Use in Specific Populations
- Pediatric use has not been evaluated in clinical studies.
- Geriatric Use: No substantive differences in safety or effectiveness were observed between subjects 65 years old and over and younger subjects.
For full prescribing information, please visit www.recothrom.com.
