pharmacopeia
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Mechanism of action

Sourced from openFDA

The mechanism of action of TachoSil is based on the interaction between the active biological substances (human fibrinogen and human thrombin) and the physiology of the fibrin clot formation (Fig. 3A) .

Indications

Sourced from openFDA
  • TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding.

Contraindications

Sourced from openFDA
  • Do not use TachoSil for: • Intravascular application. Bleeding from large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of TachoSil to blood flow during absorption of the product.contraindicated

Dosage & administration

Sourced from openFDA

For topical use on cardiovascular or hepatic tissue only Determine the number of patches to be applied by the size of the bleeding area. Apply the yellow, active side of the patch to the bleeding area. When applying TachoSil, do not exceed the maximum number of patches shown in Table 1 [see Warnings and Precautions (5.6) ] . Table 1. Amount of Fibrinogen and Thrombin per Total Patch Size and Maximum Number of TachoSil Patches to be Applied TachoSil Patch Size Human Fibrinogen (mg) Human Thrombin (Units) Maximum Number of Patches to be Applied 3.7 inch x 1.9 inch (9.5 cm x 4.8 cm) 337.4 123.1 10 1.9 inch x 1.9 inch (4.8 cm x 4.8 cm) 170.5 62.2 14 Apply on the surface of cardiovascular or hepatic tissue only. • Determine the number of TachoSil patches to be applied by the size of the bleeding area. ( 2 ) • Apply the yellow, active side of the patch to the bleeding surface. ( 2 ) 2.1 Preparation for Application TachoSil comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions. Discard damaged packages as resterilization is not possible. When in the operating room, the outer aluminum foil pouch may be opened in a non-sterile environment (Fig. 1A) . The inner sterile blister must be opened in a sterile environment (Fig. 1B) . Remove the TachoSil patch from the blister (Fig. 1C) , which can be used as a container for pre-moistening of the patch, if needed. Determine the size of patch(es) to be applied to the bleeding surface. Select the appropriate TachoSil patch so that it extends 1 to 2 cm beyond the margins of the wound.

Warnings & precautions

Sourced from openFDA

• Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular or hepatic tissue only. ( 5.1 ) • Can cause hypersensitivity or allergic/anaphylactoid reactions with first time or repetitive application. ( 5.2 ) • Avoid use in contaminated areas of the body or in the presence of an active infection. ( 5.3 ) • TachoSil contains collagen, which may adhere to bleeding surfaces. May carry a risk of gastrointestinal obstruction in abdominal surgery due to tissue adhesions. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the application area are adequately cleansed before administration of TachoSil. ( 5.4 ) • Avoid packing in cavities or closed spaces, because this may cause compression of underlying tissue. ( 5.5 ) • Use the least number of patches required to cover the entire bleeding area. Do not pack. Remove any unattached pieces of TachoSil. ( 5.6 ) • May carry a risk of transmitting infectious agents, such as viruses, and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent, and the Creutzfeldt-Jakob disease (CJD) agents, despite manufacturing steps designed to reduce the risk of viral transmission. ( 5.7 ) 5.1 Thrombosis Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular, or hepatic tissue only. 5.2 Hypersensitivity Reactions Hypersensitivity or allergic/anaphylactoid reactions may occur with TachoSil.

Adverse reactions

Sourced from openFDA

The adverse reactions reported in more than one percent of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection, and post-procedural bile leakage in hepatic surgery. The most common adverse reactions reported in >1% of patients during clinical trials were anemia, nausea and vomiting, fever, abdominal pain, increased white blood cell count, ascites, itching, atrial fibrillation, pleural effusion, gastrointestinal hemorrhage, wound infection, hypophosphatemia, urinary tract infection and post-procedural bile leakage in hepatic surgery. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Corza Medical GmbH at 1-800-997-1067 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cardiovascular Surgery In the cardiovascular trial, the most frequently reported adverse reactions were atrial fibrillation and pleural effusion. Seventy-four percent (74%) of patients treated with TachoSil and 75% of comparator treated patients experienced one or more clinically relevant adverse reactions (see Table 2) . Table 2.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary A review of available data suggests that major birth defects occur in 2-4% of the U.S. general population and that miscarriage occurs in 15-20% of clinically recognized pregnancies, regardless of drug exposure. Animal reproduction studies have not been conducted with TachoSil. There are no adequate and well-controlled studies in pregnant women. It is also not known whether TachoSil can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TachoSil should be administered to pregnant women only if clearly needed. 8.2 Lactation It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TachoSil is administered to nursing mothers. 8.4 Pediatric Use The use of TachoSil has been studied in patients aged one month to 16 years; use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as recommended. Use of TachoSil in the one month to 16 years age group is supported by evidence from adequate and well-controlled studies of TachoSil in adults with additional data from two clinical trials, which included 36 pediatric patients at the age of 16 years or younger.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
390 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use4512%
  2. 2Drug Ineffective348.7%
  3. 3Cerebrospinal Fluid Leakage153.8%
  4. 4Pyrexia133.3%
  5. 5Intestinal Obstruction112.8%
  6. 6Product Adhesion Issue112.8%
  7. 7Abdominal Abscess102.6%
  8. 8Post Procedural Haemorrhage92.3%
  9. 9Venous Occlusion92.3%
  10. 10Abdominal Pain82.1%
  11. 11Haematoma82.1%
  12. 12Nausea82.1%
  13. 13Pleural Effusion82.1%
  14. 14Post Procedural Complication82.1%
  15. 15Product Quality Issue82.1%

Literature

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Recent PubMed references pinned to Thrombin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 605 ClinicalTrials.gov registrations naming Thrombin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Thrombin work?
The mechanism of action of TachoSil is based on the interaction between the active biological substances (human fibrinogen and human thrombin) and the physiology of the fibrin clot formation (Fig. 3A) .
What is Thrombin used for?
According to FDA labeling, Thrombin carries indications including: TachoSil is a fibrin sealant patch indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Limitations for Use TachoSil cannot safely or effectively be used in place of sutures or other form of mechanical ligation for the treatment of major arterial or venous bleeding.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Thrombin?
Thrombin is classified as Blood coagulation factors, Local hemostatics, Blood Coagulation Factor, Unknown Cellular or Molecular Interaction, Increased Coagulation Factor Activity, Increased Coagulation Factor Concentration.
What are the brand names for Thrombin?
Thrombin is marketed under brand names including Artiss, EVARREST, Evicel, Evithrom, Raplixa, Recothrom, TachoSil, Thrombin-JMI.
What are the contraindications for Thrombin?
Thrombin labeling lists contraindications including: Do not use TachoSil for: • Intravascular application. Bleeding from large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of TachoSil to blood flow during absorption of the product.. Always consult the full prescribing information and a clinician.
Note. Data for thrombin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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