FIBRINOGEN
Background and Date of Approval
The U.S. Food and Drug Administration (FDA) granted initial approval for Fibrinogen on June 7, 2017.
Uses
Fibrinogen is primarily used to treat individuals with documented fibrinogen deficiencies or dysfunctions. This therapy is crucial in various medical scenarios, including managing bleeding disorders such as congenital fibrinogen deficiencies, disseminated intravascular coagulation (DIC), and acquired hypofibrinogenemia. It is also employed during certain surgical procedures to control excessive bleeding, particularly when patients have impaired clotting function due to conditions like liver disease or major trauma. Additionally, it may be considered in specific obstetric situations, such as managing postpartum hemorrhage.
How is it administered?
Fibrinogen can be administered through several routes, including intravenous (IV), intramuscular (IM), and in some cases, intraarterial (IA). The healthcare provider determines the administration route based on the patient's needs and the urgency of treatment.
Side Effects
The side effects of Fibrinogen include allergic reactions (itching, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat), transfusion reactions (acute hemolytic reactions, febrile non-hemolytic reactions), fluid overload, thrombosis (excessive blood clot formation), risk of transfusion-transmitted infections, hypersensitivity reactions in patients with known allergies,
Warnings
Patients may experience allergic reactions, including itching, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. Transfusion-related reactions, such as acute hemolytic reactions (destruction of red blood cells), febrile non-hemolytic reactions (fever), and other adverse events, can occur during or after fibrinogen replacement. Administering large volumes of blood products can lead to fluid overload, particularly in patients with cardiac or renal conditions. There is a risk of excessive blood clot formation (thrombosis), especially in patients with underlying clotting disorders.
Precautions
After taking Fibrinogen, patients should be monitored closely for signs of allergic reactions, such as itching, hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. If any of these symptoms occur, immediate medical attention is required. Close monitoring is necessary to detect and manage transfusion reactions promptly. Patients with underlying clotting disorders should be carefully evaluated for excessive blood clot formation (thrombosis) risk.
Word of Advice
Assessment of patients should include evaluation for allergies and allergic reactions, as well as screening for underlying medical conditions including cardiovascular, liver, and kidney diseases, as these may influence fibrinogen therapy. Drug interactions must be evaluated and managed appropriately, particularly with anticoagulant and antiplatelet medications. Thrombocytopenia, renal impairment, and a history of multiple transfusions can affect treatment response and necessitate careful monitoring. Patients administered human plasma-derived fibrinogen should be counselled regarding the minimal risk of viral transmission.
References
KD Tripathi, Essentials of Medical Pharmacology, Drugs affecting coagulation, Bleeding and Thrombosis, 7th edition, 2013, 616. Grifols UK Ltd, Electronic medicines compendium (EMC), [Revised on 4th August 2023] [Accessed on 8th September 2023], https://www.medicines.org.uk/emc/files/pil.5909.pdf Octapharma USA Inc, US Food and Drug Administration, [Revised on Dec 2020] [Accessed on 8th September 2023], https://www.fda.gov/media/105864/download
Frequently Asked Questions
Is fibrinogen therapy a lifelong treatment for congenital fibrinogen deficiency?
For individuals with congenital fibrinogen deficiency, fibrinogen therapy is often required throughout their lifetime to prevent bleeding episodes. The treatment plan is tailored to the patient's specific needs.
Can fibrinogen therapy cause blood clots (thrombosis)?
While fibrinogen therapy promotes clot formation, it must be administered carefully to avoid excessive clotting (thrombosis). Patients at risk of thrombosis or with a history of clotting disorders should be closely monitored during treatment.
Is it safe to receive too much fibrinogen?
Yes, excessive fibrinogen therapy can lead to an increased risk of thrombosis (clot formation). Healthcare providers closely monitor fibrinogen levels during treatment to ensure they remain within the desired range.
Can fibrinogen be used in rare bleeding disorders other than fibrinogen deficiency?
Fibrinogen may be considered in rare bleeding disorders characterized by dysfunction in fibrinogen function or in cases of acquired fibrinogen deficiencies due to underlying medical conditions.
Is it safe to resume fibrinogen after experiencing side effects?
Whether to continue fibrinogen after experiencing side effects should be carefully evaluated by healthcare providers. In some cases, therapy may be resumed with precautions, while alternative treatments may be considered in others.