Thrombin-jmi

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Thrombin-jmi Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Thrombin [bovine origin] 5000 IU, 20000 IU; per vial; pwd for topical use after reconstitution; preservative-free.

    Pharmacological Class

    Topical hemostatic.

    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

    Storage

    Store at 2°C-25°C (36°F-77°F).

    Manufacturer

    Pfizer Inc.

    Thrombin-jmi Indications

    Indications

    Aid to hemostasis for oozing blood and minor bleeding from accessible capillaries and small venules. Adjunct for surgical hemostasis with absorbable gelatin sponge.

    Thrombin-jmi Dosage and Administration

    Adult

    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.

    Adult

    For topical use on the surface of bleeding tissue only. Can be used in a dry form on oozing surfaces.

    Concentrations of 1000 International Units per mL may be required where bleeding is profuse (eg, abraded surfaces of liver or spleen).

    Solutions containing approximately 100 International Units per mL are frequently used for plastic surgery, dental extractions, skin grafting, etc.

    Topical application

    • The recipient surface should be sponged (not wiped) free of blood before applying Thrombin-JMI. 
    • A spray may be used or the surface may be flooded using a sterile syringe and small gauge needle. 
    • The most effective hemostasis results occur when Thrombin-JMI mixes freely with the blood as soon as it reaches the surface.
    • Sponging of the treated surfaces should be avoided to assure that the clot remains securely in place.

    Use in conjunction with Absorbable Gelatin Sponge

    • See labeling for sponge prior to use.
    • Immerse sponge strips of the desired size in Thrombin-JMI solution; remove trapped air by kneading the strips vigorously with moistened, gloved fingers.
    • Apply saturated sponge to bleeding area; hold in place with a pledget of cotton or small gauze sponge until hemostasis occurs.

    Use in conjunction with GEL-FLOW NT

    • Thrombin-JMI may be used with GEL-FLOW NT according to the directions for use in the GEL-FLOW NT package insert.

    Children

    Not established.

    Thrombin-jmi Contraindications

    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.

    Thrombin-jmi Boxed Warnings

    Boxed Warning

    Severe bleeding and thrombosis complications.

    Boxed Warning

    Severe bleeding and thrombosis complications

    • Thrombin-JMI can cause fatal bleeding or thrombosis.
    • Thrombosis may result from the development of antibodies against bovine thrombin.
    • Bleeding may result from the development of antibodies against factor V; these may cross-react with human factor V and lead to its deficiency.
    • Do not re-expose patients if there are known or suspected antibodies to bovine thrombin and/or factor V (see Contraindications).
    • Monitor for abnormal coagulation lab values, bleeding, or thrombosis.

    Thrombin-jmi Warnings/Precautions

    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.

    Pregnancy Considerations

    It is unknown whether Thrombin-JMI can cause fetal harm or whether it can affect reproduction capacity. Only administer to pregnant women if clearly needed.

    Nursing Mother Considerations

    Use caution when administering to nursing women as it is unknown whether the drug is excreted in human milk.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    Clinical studies did not include a sufficient number of patients aged 65 and older to determine difference in response; use caution with dose selection.

    Thrombin-jmi Pharmacokinetics

    See Literature

    Thrombin-jmi Interactions

    Not Applicable

    Thrombin-jmi Adverse Reactions

    Adverse Reactions

    Hypersensitivity reactions, bleeding, anemia, post-op wound infection, thromboembolic events, hypotension, pyrexia, tachycardia, thrombocytopenia.

    Thrombin-jmi Clinical Trials

    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.

    Thrombin-jmi Note

    Not Applicable

    Thrombin-jmi Patient Counseling

    Patient Counseling

    Thrombin-JMI may cause the formation of clots in blood vessels if absorbed systemically; report tenderness or swelling, chest pain, shortness of breath, or difficulty speaking or swallowing.

    • Latest News Your top articles for Wednesday

    • Haymarket Medical NetworkTop Picks

    • Loading...

      Continuing Medical Education (CME/CE) Courses

      Show More