![TachoSil THROMBIN HUMAN and FIBRINOGEN 2 [USP'U]/1; 5.5 mg Patch, 1 patch — NDC 83078-0704-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0c324332-290f-413f-820c-8c9a971a2766&name=sample.jpg)
TachoSil THROMBIN HUMAN and FIBRINOGEN 2 [USP'U]/1; 5.5 mg Patch, 1 patch
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Blood Coagulation Factor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| TachoSil 2 [USP'U]/1; 5.5 mg 83078-0701-01 | Corza | 1 patch | — | — | FDA listed | — |
| TachoSil 2 [USP'U]/1; 5.5 mgthis 83078-0704-01 | Corza | 1 patch | — | — | FDA listed | — |
| TachoSil 2 [USP'U]/1; 5.5 mg 83078-0702-02 | Corza | 2 patches | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Apr 5, 2022 |
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🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83078-0704-01 You're viewing this | 1 POUCH in 1 CARTON (83078-704-01) / 1 BLISTER PACK in 1 POUCH (83078-704-00) / 1 PATCH in 1 BLISTER PACK (83078-704-99) | 2023-04-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. Not for use in children under one month of age.
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. ( 1 ) Limitations for Use Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. ( 1 ) Not for use in children under one month of age.
( 8.4 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 )
2.1Preparation 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. The patch can be cut to the correct size and shape if desired (Fig. 1D) .
If more than one patch is used, overlap patches by at least 1 cm. Prior to application, cleanse the area to be treated to remove disinfectants and other fluids. The fibrinogen and thrombin proteins can be denatured by alcohol, iodine or heavy metal ions.
If any of these substances have been used to clean the wound area, thoroughly irrigate the area before the application of TachoSil. Apply TachoSil directly to the bleeding area either wet or dry. If applied wet, pre-moisten TachoSil in 0.9% saline solution and then apply immediately.
In the case of a wet tissue surface (e.g., oozing bleeding) TachoSil may be applied without pre-moistening. Figure 1: Pictures illustrating steps for preparation for application of TachoSil A B C D 21a 21b 21c 21d
2.2Method of Application To ensure TachoSil adheres effectively, follow the recommended handling, preparation, and application procedures. Incorrect handling may result in non-adherence and reduced efficacy of TachoSil. Cleanse surgical instruments, gloves and adjacent tissues with saline solution to reduce the adherence to the TachoSil patch.
The white, inactive side of TachoSil may also adhere to surgical instruments (e.g., forceps), gloves or adjacent tissues covered with blood due to the affinity of collagen to blood. It is important to note that failure to adequately clean adjacent tissues may cause adhesions [see Warnings and Precautions (5.4) ] . Apply the yellow, active side of the patch to the bleeding area (Fig.
2A) and hold in place with gentle pressure applied through moistened gloves or a moist pad for at least three minutes (Fig. 2B) . To avoid pulling the patch loose, first place a clean surgical instrument at one end of the patch before relieving the pressure (Fig.
2C) . Gentle irrigation may also aid in removing the pre-moistened pad or gloved hand without removing TachoSil from the bleeding area. Leave TachoSil in place once it adheres to organ tissue.
Only remove unattached TachoSil patches (or part of) and replace with new patches. TachoSil cannot be resterilized once removed from inner pouch. Discard unused, opened packages of TachoSil at the end of the procedure.
Figure 2: Pictures illustrating steps for method of application of TachoSil A B C Record patient name and TachoSil batch number every time that…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. The active side of the patch is yellow in color due to the presence of a colorant riboflavin (E101); and the non-active side is off-white in color. Strength: Each absorbable TachoSil patch contains: Per square inch: Human fibrinogen 23.2 – 47.7 mg (35.5 mg) Human thrombin 8.4 –
17.4Units (12.9 U) Per square centimeter: Human fibrinogen 3.6 – 7.4 mg (5.5 mg) Human thrombin 1.3 –
2.7Units (2.0 U) TachoSil is a topical fibrin sealant patch consisting of human fibrinogen and human thrombin coated onto an equine collagen sponge. Each absorbable patch contains, per square inch (inch 2 ): human fibrinogen 23.2 to 47.7 mg (35.5 mg); human thrombin 8.4 to
17.4Units (12.9 U) per cm 2 : human fibrinogen 3.6 to 7.4 mg (5.5 mg); human thrombin 1.3 to
2.7Units (2.0 U). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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. This can result in life-threatening thromboembolic events [see Warnings and Precautions (5.1) ] . • Individuals known to have anaphylactic or severe systemic reaction to human blood products or horse proteins [see Warnings and Precautions (5.2) ] .
Do not apply TachoSil intravascularly. Intravascular application of TachoSil may result in life-threatening thromboembolic events. ( 4 ) Do not use TachoSil in individuals with known hypersensitivity to human blood products or horse proteins.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • 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 )
5.1Thrombosis Thrombosis can occur if TachoSil is applied intravascularly. Ensure that TachoSil is applied to the surface of cardiac, vascular, or hepatic tissue only.
5.2Hypersensitivity Reactions Hypersensitivity or allergic/anaphylactoid reactions may occur with TachoSil. Symptoms associated with allergic anaphylactic reactions include: flush, urticaria, pruritus, nausea, drop in blood pressure, tachycardia or bradycardia, dyspnea, severe hypotension and anaphylactic shock. These reactions may occur in patients receiving TachoSil for the first time or may increase with repetitive applications of TachoSil.
5.3Infection Avoid application to contaminated or infected areas of the body, or in the presence of active infection.
5.4Adhesions TachoSil contains collagen, which may adhere to bleeding surfaces. To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil [see Dosage and Administration (2.2 )] . Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
5.5Compression When placing TachoSil into cavities or closed spaces, avoid packing because this may cause compression of underlying tissue.
5.6Non-Adherence or Dislodged Material Non-adherence has occurred after TachoSil application [see Postmarketing Experience (6.2) ]. Follow proper handling, preparation, and application procedures to reduce the risk of non-adherence of TachoSil [see Dosage and Administration (2.2) ]. Theoretically, excess patch material can become dislodged and migrate to other areas of the body.
Use only minimum amount of TachoSil patches necessary to achieve hemostasis. Remove unattached pieces of TachoSil; if medically necessary [see Dosage and Administration (2.2) ] .
5.7Transmissible Infectious Agents Because the biological components of this product are made from human blood, it may carry a risk of transmitting infectious agents (e.g., viruses), and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent and the Creutzfeldt-Jakob disease (CJD) agent. The risk that TachoSil will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain virus infections, and by inactivating and removing, certain viruses [see Description (11) ] .
Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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. Most Frequent Adverse Reactions (Cardiovascular Trial) Adverse Reaction TachoSil Comparator Comparator: Hemostatic fleece material without additional active coagulation stimulating compounds. N = 62 As treated population (safety data set). n (%) N = 57 n (%) Atrial fibrillation 18 (29%) 14 (25%) Pleural effusion 14 (23%) 11 (19%) Pyrexia 4 (6%) 3 (5%) Hepatic Surgery In the hepatic surgery trial, the most frequently reported adverse reactions were nausea and anemia (see Table 3).
Ninety-four percent (94%) of patients treated with TachoSil and 94% of comparator treated patients experienced one or more clinically relevant adverse reactions. Table 3. Most Frequent Adverse Reactions (Hepatic Resection Trial) Adverse Reaction TachoSil Comparator Comparator: Hemostatic fleece material without additional active coagulation stimulating compounds.
N = 114 As treated population (safety data set). n (%) N = 109 n (%) Nausea 34 (30%) 29 (27%) Anemia 26 (23%) 23 (21%) Post-operative bile leakage was observed in 8 (7%) of patients after treatment with TachoSil and 13 (12%) after treatment with comparator. Immunogenicity Antibodies against components of fibrin sealant/hemostatic products may occur. However in a clinical trial with human fibrinogen/human thrombin sponge (patch) in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with human fibrinogen/human thrombin sponge (patch) developed antibodies to equine collagen.
The equine collagen antibodies that developed in some patients after human fibrinogen/human thrombin sponge (patch) use were not reactive with human collagen. One patient developed antibodies to human fibrinogen. There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
There is very limited clinical data available regarding re-exposure of the human fibrinogen/human thrombin sponge (patch). Two subjects have been re-exposed in a clinical trial and have not reported any immune-mediated adverse events, however, their antibody status to collagen or fibrinogen is unknown. Pediatric Clinical Trial Experience In pediatric patients, the most frequently reported adverse reactions were diarrhea, hypertension and increased transaminases (see Table 4).
Ninety-four percent (94%) of patients treated with TachoSil and 100% of comparator treated patients experienced one or more clinically relev…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric 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. The data supports the use of TachoSil for hemostasis in pediatric patients undergoing cardiovascular and hepatic surgery [see Clinical Studies (14.3) ] .
8.5Geriatric Use Clinical trials to date included 326 patients older than 65 years of age receiving TachoSil. No overall differences in safety or effectiveness were observed between the elderly and younger patients, however, greater susceptibility of some older patients to adverse reactions cannot be ruled out.
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric 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. The data supports the use of TachoSil for hemostasis in pediatric patients undergoing cardiovascular and hepatic surgery [see Clinical Studies (14.3) ] .
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials to date included 326 patients older than 65 years of age receiving TachoSil. No overall differences in safety or effectiveness were observed between the elderly and younger patients, however, greater susceptibility of some older patients to adverse reactions cannot be ruled out.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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) . Upon contact with a bleeding wound surface, the active substances coated onto the equine collagen patch become dissolved and partly diffuse into the wound surface.
The subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions-conversion of fibrinogen into fibrin monomers that further polymerize to form the fibrin clot. Hemostasis is achieved when the formed fibrin clot adheres the collagen patch to the wound surface, thus providing a physical barrier to bleeding (Fig 3B) . TachoSil exhibits flexibility to accommodate for the physiological movements of tissues and organs and can withstand pressures up to 61.4 hPa (46.1 mmHg).
Figure 3: Scanning Electron Microscopy Photos of TachoSil A . The side view of the TachoSil patch shows the coating of the human plasma components anchored to the indentations of the collagen carrier. B .
The deposition of a fibrin clot formed from fibrinogen and thrombin of the coating results in hemostasis and conglutination of the TachoSil patch to the wound surface. 12a 12b
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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) . Upon contact with a bleeding wound surface, the active substances coated onto the equine collagen patch become dissolved and partly diffuse into the wound surface.
The subsequent fibrinogen-thrombin reaction initiates the last step in the cascade of biochemical reactions-conversion of fibrinogen into fibrin monomers that further polymerize to form the fibrin clot. Hemostasis is achieved when the formed fibrin clot adheres the collagen patch to the wound surface, thus providing a physical barrier to bleeding (Fig 3B) . TachoSil exhibits flexibility to accommodate for the physiological movements of tissues and organs and can withstand pressures up to 61.4 hPa (46.1 mmHg).
Figure 3: Scanning Electron Microscopy Photos of TachoSil A . The side view of the TachoSil patch shows the coating of the human plasma components anchored to the indentations of the collagen carrier. B .
The deposition of a fibrin clot formed from fibrinogen and thrombin of the coating results in hemostasis and conglutination of the TachoSil patch to the wound surface. 12a 12b
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each TachoSil patch is packaged individually in a tray with lidding. This is placed in an outer pouch with a desiccant bag and packaged into a folding carton. TachoSil is supplied in the following pack sizes: Package with 1 patch of 3.7 inch x 1.9 inch (9.5 cm x 4.8 cm) (NDC 83078-701-01) Package with 2 patches of 1.9 inch x 1.9 inch (4.8 cm x 4.8 cm) (NDC 83078-702-02) Storage Use TachoSil before expiration date indicated on the package.
Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze.
Do not use if package is opened or damaged.
📦 Storage and Handling ▾
Storage Use TachoSil before expiration date indicated on the package. Store unopened packages of TachoSil between 2ºC and 25ºC. TachoSil does not require refrigeration. Do not freeze. Do not use if package is opened or damaged.
📋 Description ▾
11 DESCRIPTION TachoSil Fibrin Sealant Patch is a sterile, bioabsorbable combination product comprised of two active substances (human plasma-derived fibrinogen and human plasma-derived thrombin) coated onto a collagen sponge of equine origin. The collagen sponge serves as a flexible and mechanically stable carrier for the active substances to facilitate application of the human fibrinogen and thrombin to the wound surface. The active side of the patch is yellow in color due to the presence of a colorant riboflavin (E101); and the non-active side is off-white in color.
Each square inch of the patch contains approximately 35.5 mg of human fibrinogen and 12.9 units of human thrombin. Other inactive ingredients include equine collagen, human albumin, sodium chloride, sodium citrate, and L‑arginine hydrochloride. TachoSil is sterilized by gamma irradiation after completion of inner and outer packaging, resulting in a sterile product in a sterile inner package.
Viral Clearance The active biological substances of TachoSil (human fibrinogen and human thrombin) are manufactured from pooled human plasma collected in facilities in the United States. Human plasma is tested by a Nucleic Acid Test (NAT) for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus-1 (HIV-1). NAT testing for hepatitis A virus (HAV) and parvovirus B19 is also performed.
Human plasma is also tested for the presence of hepatitis B surface antigen (HBsAg), and antibodies to hepatitis C virus (anti-HCV) and human immunodeficiency viruses types 1 and 2 (anti-HIV 1/2). The manufacturing procedure for each TachoSil component and final product include processing steps designed to reduce the risk of viral transmission. In particular, the virus clearance steps in the manufacture of human fibrinogen and thrombin include pasteurization, precipitation and adsorption.
The virus clearance step in the manufacture of the collagen sponge is the pH treatment. The virus clearance capacity of these procedures in the manufacture of fibrinogen, thrombin and collagen sponge has been validated using viruses with a wide range of physicochemical characteristics. These in vitro validation studies were conducted using samples from manufacturing intermediates spiked with virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps.
The cumulative virus reduction factors (expressed as log 10 ) are shown in Table 5 for each virus tested. Table 5. Cumulative Virus Reduction Factors for the Components of TachoSil Cumulative Reduction Factors for Virus Removal/Inactivation of Human Thrombin Virus Reduction Factors [log 10 ] Manufacturing step Enveloped Viruses Non-enveloped Viruses HIV HIV: Human Immunodeficiency Virus, HSV HSV: Herpes Simplex Virus BVDV BVDV: Bovine Viral Diarrhea Virus PRV PRV: Pseudorabies Virus CPV CPV: Canine parvovirus HAV HAV: Hepatitis A Virus Pasteurization, precipitation and adsorption steps 15.0 20.4 13.2 16.3 5.4
8.4Cumulative Reduction Factors for Virus Removal/Inactivation of Human Fibrinogen Virus Reduction Factors [log 10 ] Manufacturing step Enveloped Viruses Non-enveloped Viruses HIV PRV BVDV WNV WNV: West Nile Virus, only single manufacturing step validated CPV HAV Pasteurization, precipitation and lyophilization steps 9.6 8.8 11.2 8.3 4.9
8.6Reduction Factors for Virus Removal/Inactivation of the Collagen Sponge (equine) Virus Reduction Factors [log 10 ] Manufacturing step Enveloped Viruses Non-enveloped Viruses PRV PI-3 PI-3: Parainfluenza Virus type 3 PPV PPV: Porcine Parvovirus Reo3 Reo 3: ReoVirus type 3 pH treatment 5.7 5.9 --- --- A validation study was also conducted to evaluate the capacity for gamma irradiation to inactivate and/or remove viruses in the final TachoSil product. The virus reduction factors (expressed as log 10 ) are shown in Table 6 for each virus tested.
Table 6. Virus Reduction Factors for TachoSil Final Sterilization by Gamma…
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Because TachoSil may cause the formation of clots in blood vessels if exposed intravascularly, advise patients to consult their physician if they experience chest pain, shortness of breath or difficulty speaking or swallowing, or leg tenderness or swelling [see Warnings and Precautions (5.1) ] . Instruct patients to consult their physician if symptoms of B19 virus infection appear (fever, drowsiness and chills) followed about two weeks later by a rash and joint pain. Parvovirus B19 most seriously affects pregnant women (fetal infection); immune-compromised individuals or individuals with an increased erythropoiesis (e.g., hemolytic anemia) [see Warnings and Precautions (5.7) ] .
Advise patients that, because TachoSil is made from human blood, it may carry a risk of transmitting infectious agents (e.g., viruses), and theoretically, the Creutzfeldt-Jakob (CJD) agent [see Warnings and Precautions (5.7) ] .