Fibrinogen/Thrombin

Fibrinogen/thrombin is used as an adjunct to hemostasis for mild-to-moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (e.g., suture, ligature, cautery) is ineffective or impractical.

Fibrinogen/thrombin is available under the following different brand names: Raplixa.

Dosages of Fibrinogen/Thrombin:

Dosage Forms and Strengths

Topical Dry Powder

• (79mg/699 IU)/g
• Supplied in single-use glass vials: 0.5g, 1g, and 2g

Dosage Considerations – Should be Given as Follows:

Hemorrhage Control

• Topical fibrin sealant indicated as an adjunct to hemostasis for mild-to-moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (e.g., suture, ligature, cautery) is ineffective or impractical
• The required amount to stop bleeding varies and is based on the size of the bleeding area
• Not to exceed a total dose of 3 g per surgery

Direct application dose

• Dose according to the maximum surface area of the bleeding area to be treated
• 25 cm²: 0.5 g vial
• 50 cm²: 1 g vial
• 100 cm²: 2 g vial

Dose using RaplixaSpray device

• Dose according to the maximum surface area of the bleeding area to be treated
• 50 cm²: 0.5 g vial
• 100 cm²: 1 g vial
• 200 cm²: 2 g vial

Safety and efficacy not established in pediatric patients

Adverse effects reported were similar to the use of gelatin sponge alone

Common side effects of fibrinogen/thrombin include:

• Procedural pain
• Nausea
• Constipation
• Incision site pain
• Fever
• Anemia
• Vomiting
• Low blood pressure (hypotension)
• Itching
• High blood pressure (hypertension)
• Antithrombin antibodies

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fibrinogen/thrombin has no listed severe interactions with other drugs.
• Fibrinogen/thrombin has no listed serious interactions with other drugs.
• Fibrinogen/thrombin has no listed moderate interactions with other drugs.
• Fibrinogen/thrombin has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains fibrinogen/thrombin. Do not take Raplixa if you are allergic to fibrinogen/thrombin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Intravascular application
• Severe or brisk arterial bleeding
• Known anaphylactic or severe systemic reactions to human blood products

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Fibrinogen/Thrombin?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Fibrinogen/Thrombin?”

Cautions

• Life-threatening thromboembolic events may result from intravascular application
• Air or gas embolism has occurred with the use of spray devices using pressure regulators to administer fibrin sealants; this appears to be related to the use of the spray device at higher than the manufacturer recommended pressures and close to the tissue surface; minimize this risk by precisely following manufacturer’s instructions for RaplixaSpray device
• Made from human plasma; risk of transmitting infectious agents [e.g., Creutzfeldt–Jakob disease (CJD)]; manufacturing steps designed to reduce this risk are used, as is a screening of plasma donors
• Hypersensitivity reactions may occur, including hives, generalized urticaria, tightness of chest, wheezing, hypotension, and anaphylaxis; if these symptoms occur, discontinue immediately

Pregnancy and Lactation

Animal reproduction studies have not been conducted on fibrinogen/thrombin during pregnancy. It is also not known whether fibrinogen/thrombin can cause fetal harm when administered to pregnant women or if it can affect reproductive capacity. Fibrinogen/thrombin should be given to a pregnant woman only if clearly needed.

It is unknown if fibrinogen/thrombin is distributed in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when administering to breastfeeding women.