Significantly lower rate of specific anti-product antibody formation in the Phase 3 study1

Percentage of patients with antibody development
  • At baseline 1.5% of patients (n=3/198) in the RECOTHROM group had positive anti-product antibody titers compared with 5% of patients in the bovine thrombin group (n=10/200)
    • Of these patients, 0 of 3 in the RECOTHROM group and 8 of 10 in the bovine thrombin group, increased antibody titer ≥ 1.0 unit (≥ 10 fold) after study treatment
  • After surgery, a significantly higher percentage of patients (21.5%) developed antibodies to bovine thrombin product
    compared to RECOTHROM (1.5%)
  • The study was not powered to detect differences in clinical outcomes based on the development of antibodies
  • The overall incidence of adverse events was similar between treatment groups
  • Limited data are currently available on repeat exposure to RECOTHROM

Patients with antibodies to bovine thrombin should not be reexposed2. No commercially available test exists to detect bovine thrombin antibody development.

Pooled immunogenicity observations from completed RECOTHROM clinical trials3

In completed clinical studies, 5 of 552 (0.9%) patients exposed to RECOTHROM with both baseline and post-treatment antibody specimens available, developed specific anti-RECOTHROM product antibodies. None of these antibodies were found to neutralize native human thrombin.

REFERENCES:

  1. 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;205:256-265.
  2. Thrombin-JMI® (package insert). King Pharmaceuticals.
  3. Ballard JL, Weaver FA, Singla NK, et al. Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin. J Am Coll Surg. 2010;210:199-204.

Adverse event data from Phase 3 study comparing RECOTHROM to bovine thrombin1

  • Overall incidence of adverse events was similar between treatment groups
  • The most commonly reported adverse events observed for RECOTHROM and bovine thrombin, respectively, were:
    Incision site pain (63%, 63%), procedural pain (29%, 34%), and nausea (28%, 35%)
    • Serious adverse events were reported by 18% of patients treated with RECOTHROM and 22% of patients treated with bovine thrombin

Pooled adverse event observations from completed RECOTHROM clinical trials2

  • The most common adverse events were incision site pain (51%), procedural pain (30%), and nausea (28%).
  • The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in these trials was atrial fibrillation.
  • Adverse events reported in clinical trials of RECOTHROM were consistent with those commonly observed in surgical patients.

Important Safety Considerations

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

Potential risk of thrombosis if absorbed systemically.

Do not use for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.

REFERENCES:

  1. 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;205:256-265.
  2. Ballard JL, Weaver FA, Singla NK, et al. Safety and immunogenicity observations pooled from eight clinical trials of recombinant human thrombin. J Am Coll Surg. 2010;210:199-204.