HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all of the information needed to use RECOTHROM safely and effectively. See full prescribing information for RECOTHROM.

RECOTHROM Thrombin, topical (Recombinant)

Powder for solution - For Topical Use Only

Initial U.S. Approval: 2008

—————————————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 (such as suture, ligature, or cautery) is ineffective or impractical (1).
RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP (1).

————————————DOSAGE AND ADMINISTRATION————————————

  • For topical use only. DO NOT INJECT (2).
  • Reconstitute RECOTHROM powder with sterile 0.9% sodium chloride, USP, yielding a solution containing
    1000 units1/mL (2.1).
  • 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 (2.2).

———————————DOSAGE FORMS AND STRENGTHS———————————

RECOTHROM is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin powder for solution. When reconstituted as directed with the provided steril 0.9% sodium chloride, USP, the final solution contains 1000 units/mL of RECOTHROM (3).

——————————————CONTRAINDICATIONS——————————————

  • Do not inject directly into the circulatory system (4).
  • Do not use for the treatment of massive or brisk arterial bleeding (4).
  • Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins (4).

————————————WARNINGS AND PRECAUTIONS————————————

  • Potential risk of thrombosis if absorbed systemically (5).
  • In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction (5).

——————————————ADVERSE REACTIONS——————————————

  • The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events reported in clinical trials of RECOTHROM were incision site pain, procedural pain, and nausea (6.1).
  • The incidence of antibody formation to RECOTHROM in completed clinical trials is 0.9%, (n=5/552). None of the antibodies detected in RECOTHROM treated patients neutralized native human thrombin (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact ZymoGenetics, Inc. at 1-888-784-7662, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

————————————USE IN SPECIFIC POPULATIONS————————————

Pregnancy: No human or animal data. Use only if clearly needed (8.1).


1 Units used herein represent international units of potency determined using a reference standard that has been calibrated against the World Health Organization Second International Standard for Thrombin.

Revised: 12/ 2009