Fibryga

Fibryga is a prescription human fibrinogen concentrate used for fibrinogen deficiency, a condition where the blood has low levels of fibrinogen (clotting factor I), a key protein needed for forming stable blood clots. Low levels of fibrinogen make it difficult for blood to clot.

Fibrinogen deficiency increases the risk of severe, uncontrolled bleeding that can be life-threatening, especially during major bleeding events (such as trauma, childbirth, or surgery).

Fibryga is given by IV infusion to raise fibrinogen levels and help stop bleeding.

Fibryga is FDA-approved to be used for:

• Acquired fibrinogen deficiency in bleeding patients
• Congenital fibrinogen deficiency in patients with acute bleeding episodes, including afibrinogenemia and hypofibrinogenemia.

Fibryga is not indicated for dysfibrinogenemia, which is when you have normal levels of fibrinogen, but they are dysfunctional and do not work properly.

Acquired fibrinogen deficiency (AFD)

AFD occurs when fibrinogen levels become low due to an illness or situation (such as major bleeding or transfusion, disseminated intravascular coagulation, liver-related issues, or major surgery). Low fibrinogen can make it difficult to form and maintain blood clots.

For more information, see "What is Acquired Fibrinogen Deficiency (AFD)?"

Congenital fibrinogen deficiency (Factor I deficiency)

This is a rare inherited bleeding disorder where the body makes too little fibrinogen (hypofibrinogenemia) or none at all (afibrinogenemia). Because fibrinogen is essential to form stable blood clots, people may have easy bruising, nosebleeds, heavy menstrual bleeding, bleeding after injury/surgery, or spontaneous bleeding.

Fibrinogen is a soluble plasma protein that is converted into insoluble fibrin, a key structural component of a blood clot. Fibryga works by replacing missing fibrinogen or raising low fibrinogen levels so the body can form stronger clots and achieve hemostasis (bleeding control).

Acquired fibrinogen deficiency (cardiac surgery bleeding)

In a randomized controlled study, FIBRES (NCT03037424) in adult cardiac surgery patients with clinically significant bleeding and low fibrinogen, Fibryga was non-inferior to cryoprecipitate based on the primary outcome (the total number of allogeneic blood product units transfused within 24 hours after cardiopulmonary bypass).

Congenital fibrinogen deficiency (acute bleeds)

In clinical studies of congenital fibrinogen deficiency (FORMA-02, FORMA‐04 (NCT02408484) efficacy for treating bleeding events was assessed using a 4-point hemostatic scale called the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC). In the paediatric study, FORMA‐04, Fibryga effectiveness using IDMEAC demonstrated 100% efficacious for on‐demand treatment of bleeding and surgical prophylaxis.

Fibryga is given intravenously (IV) after it is reconstituted (mixed) with sterile Water for Injection, using aseptic technique.

Key administration points from prescribing information:

• Give by slow IV infusion at room temperature.
• Flush the infusion line with normal saline before and after administration.
• After reconstitution: do not refrigerate or freeze; use immediately or within 4 hours.
• Discard any remaining solution.

• Severe allergic reactions: Hypersensitivity reactions may occur; stop infusion and get treatment if symptoms appear.
• Blood clot risk: Thrombotic events have been reported with Fibryga. The benefits of treatment should be weighed against the risk of thrombosis, and patients should be monitored for signs/symptoms of clots.
• Made from human plasma: Products made from human plasma may carry a risk of infectious agents.

You should not receive Fibryga if you have had an anaphylactic or severe reaction to Fibryga or its components, including:

• Sodium citrate dihydrate
• Glycine
• L-arginine hydrochloride

You should not use fibrinogen if you are allergic to it, or if you have ever had a severe allergic reaction.

To make sure fibrinogen is safe for you, tell your doctor if you have:

• a history of stroke or blood clot.

It is not known whether fibrinogen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby.

Fibrinogen is made from human plasma (part of the blood), which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Common Fibryga side effects

Common side effects of Fibryga when used for acquired fibrinogen deficiency are abnormal liver function, acute kidney injury, anemia, atrial fibrillation, delirium, and renal failure.

The most common side effects when Fibryga is used for congenital fibrinogen deficiency are nausea, vomiting, fever, and thrombocytosis.

Serious side effects (seek urgent medical care)

Get emergency medical help if you have signs of an allergic reaction: hives, rash, tightness in your chest, wheezing, difficulty breathing, feeling like you might pass out, swelling of your face, lips, tongue, or throat.

Fibrinogen may cause other serious side effects. Stop using fibrinogen and call your doctor at once if you have:

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance
• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs; or
• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

• Fibryga should not be administered in the same IV tubing or container as other medications.
• Avoid using Fibryga if the solution looks discolored or has particles after mixing.
• Follow your care team’s instructions about activity if you are at higher risk of blood clots (for example, after surgery), and report symptoms promptly.

Fibryga dosing is individualized and guided by fibrinogen levels and the clinical situation.

Dosing may be adjusted depending on plasma fibrinogen levels or viscoelastic testing, severity of bleeding, body weight, or the patient’s clinical condition.

The injection rate should not exceed 20 mL per minute for acquired fibrinogen deficiency, and should not exceed 5 mL per minute for congenital fibrinogen deficiency.

Monitoring of the patient’s plasma fibrinogen level or the viscoelastic properties of the fibrin-based clot is recommended during treatment.

• See detailed dosing on the Fibryga Dose Page

Other drugs may interact with fibrinogen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Do not mix or co-infuse Fibryga with other medications in the same tubing/container.

Because Fibryga affects clot formation, clinicians commonly review other medicines that affect clotting/bleeding risk (for example, anticoagulants or procoagulant agents) and monitor closely, especially in high-risk patients.

Active ingredient: Human fibrinogen

Inactive ingredients (nominal, per mL): Sodium chloride, sodium citrate dihydrate, glycine, L-arginine hydrochloride.

Contains no preservatives.

Distributed by (U.S.): Octapharma USA, Inc., Paramus, NJManufactured by: Octapharma Pharmazeutika Produktionsges.m.b.H. (Vienna, Austria) and Octapharma AB (Sweden).

• What is Acquired Fibrinogen Deficiency (AFD)?