Bleeding disorders:
Indications for: THROMBIN-JMI
Aid to hemostasis for oozing blood and minor bleeding from accessible capillaries and small venules. Adjunct for surgical hemostasis with absorbable gelatin sponge.
Clinical Trials:
In a double-blinded, controlled trial, patients were randomly assigned to receive Thrombin-JMI (n=206) or recombinant human thrombin (n=205) as adjuncts to hemostasis in liver resection, spine, peripheral arterial bypass, and dialysis access surgeries; 401 patients completed the trial.
The reported adverse reactions in both treatment groups were: cardiac events (18%), hypersensitivity (17%), other infections (15%), bleeding (11%), postoperative wound infection (10%) and thromboembolic events (5%).
Among 200 patients who were evaluated for the presence of antibodies to Thrombin-JMI, 10 patient (5%) were positive at baseline and 43 (21.5%) after treatment. The seroconversion rate in the Thrombin-JMI group was 18.4%.
In another prospective, double-blinded, controlled trial patients were randomly assigned to receive Thrombin-JMI (n=152) or human thrombin (n=153) applied topically to the target bleeding site with a gelatin sponge.
Sixteen out of 126 (12.7%) patients in the Thrombin-JMI arm demonstrated seroconversion for at least 1 of the 4 antibodies assayed. Serious adverse reactions (pyrexia and post-procedural hematoma) were reported in 2 patients in the Thrombin-JMI group.
The effect of repeat exposure was evaluated in a prospective, double-blinded, controlled trial that included 72 patients with diabetic foot ulcers, using a gel prepared with Thrombin-JMI and autologous platelet rich plasma that was applied weekly for 12 weeks. No serious adverse reactions related to the gel treatment were reported.
In an open-label, observational study (MOSAIC), the effect of possible exposure to Thrombin-JMI on activated partial thromboplastin time (aPTT) at 48 hours post-surgery in patients with likelihood of prior exposure to Thrombin-JMI within the past 4 years was assessed.
The impact of exposure to Thrombin-JMI in 78 patients who were positive for anti-bovine thrombin (aBT) antibodies prior to surgery was compared with 140 patients who did not have any aBT antibodies and were not exposed to Thrombin-JMI.
The study did not meet the primary endpoint, a mean change from baseline in aPTT at 48 hours post-surgery. The study was not powered to detect coagulopathy related to an immune response after bovine thrombin use.
Adult Dosage:
For topical use only. See full labeling. Profuse bleeding (eg, abraided surfaces of liver or spleen): 1000 IU/mL. General use (eg. plastic surgery, dental extractions, skin grafting): 100 IU/mL. May dilute to prepare intermediate strengths, if needed. Oozing surfaces: may use dry form.
Children Dosage:
Not established.
THROMBIN-JMI Contraindications:
Direct injection into the circulatory system. Re-exposure if there are known or suspected antibodies to bovine thrombin and/or factor V. Treatment of severe or brisk arterial bleeding.
Boxed Warning:
Severe bleeding and thrombosis complications.
THROMBIN-JMI Warnings/Precautions:
Not for injection. Allergic reactions: have supportive measures available. Thrombosis. Antibody formation may interfere with hemostasis. Monitor for abnormal coagulation lab values, bleeding, thrombosis. Pregnancy. Nursing mothers.
THROMBIN-JMI Classification:
Topical hemostatic.
Adverse Reactions:
Hypersensitivity reactions, bleeding, anemia, post-op wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, thrombocytopenia.
How Supplied:
Vials—1 (w. diluent); Pump Spray Kit (20000 IU)—1 (w. diluent); Syringe Spray Kit (5000 IU, 20000 IU)—1 (w. diluent); Epistaxis Kit (5000 IU)—1 (w. diluent); Gelfoam-JMI Kit (gelatin sponge or powder)—1
