Thrombin
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
The use of topical bovine thrombin preparations has occasionally been associated with abnormalities in hemostasis ranging from asymptomatic alterations in laboratory determinations, such as prothrombin time (PT) and partial thromboplastin time (PTT), to severe bleeding or thrombosis which rarely have been fatal. These hemostatic effects appear to be related to the formation of antibodies against bovine thrombin and/or factor V which in some cases may cross react with human factor V, potentially resulting in factor V deficiency. Repeated clinical applications of topical bovine thrombin increase the likelihood that antibodies against thrombin and/or factor V may be formed.
Consultation with an expert in coagulation disorders is recommended if a patient exhibits abnormal coagulation laboratory values, abnormal bleeding, or abnormal thrombosis following the use of topical thrombin. Any interventions should consider the immunologic basis of this condition. Patients with antibodies to bovine thrombin preparations should not be re-exposed to these products.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
DOSAGE AND ADMINISTRATION Solutions of Thrombin, Topical (Bovine Origin), USP, THROMBIN-JMI ® may be reconstituted with sterile isotonic saline at a recommended concentration of 1,000 to 2,000 International Units/mL. Where bleeding is profuse, as from abraided surfaces of liver or spleen, concentrations of 1,000 International Units per mL may be required.
For general use in plastic surgery, dental extractions, skin grafting, etc. solutions containing approximately 100 International Units/mL are frequently used. Intermediate strengths to suit the needs of the case may be prepared by diluting the contents of the THROMBIN-JMI ® container with an appropriate volume of sterile isotonic saline.
If the transfer device is used for reconstitution, transfer the diluent in the following manner. Remove the plastic cap off of the diluent vial. Remove the tyvek cover from the transfer device container. Do not remove the device from the package. Seat the blue end of the device on the diluent vial, pushing down until the spike penetrates the diaphragm and the device snaps in place.
CAUTION: Solutions should be used promptly upon removal from the container. However, the solution may be refrigerated at 2°-8°C for up to 24 hours, or may be stored at room temperature for up to 8 hours after reconstitution.
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Thrombin
Contraindications
CONTRAINDICATIONS THROMBIN-JMI ® is contraindicated in persons known to be sensitive to any of its components and/or to material of bovine origin. Do not use for the treatment of massive or brisk arterial bleeding.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for thrombin. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy – Category C — Animal reproduction studies have not been conducted with THROMBIN-JMI ® . It is also not known whether THROMBIN-JMI ® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. THROMBIN-JMI ® should be given to a pregnant woman only if clearly indicated.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.