Haemocomplettan (Human Fibrinogen)

Haemocomplettan is indicated for the replacement of fibrinogen in several clinical situations where low fibrinogen contributes to bleeding risk.

• Congenital fibrinogen deficiency such as afibrinogenemia or hypofibrinogenemia.
• Acquired fibrinogen deficiency secondary to massive transfusion, liver disease, or disseminated intravascular coagulation.
• Bleeding associated with major trauma or surgery when plasma fibrinogen levels are below therapeutic thresholds.
• Management of hemorrhage in obstetric complications, such as postpartum hemorrhage, where fibrinogen depletion is documented.
• Adjunctive therapy during cardiac surgery or cardiopulmonary bypass to maintain hemostasis.

Adverse reactions reported with Haemocomplettan are generally related to infusion and immunologic responses.

Common

• Mild fever or chills during infusion.
• Transient headache.
• Nausea or vomiting.
• Localized erythema or swelling at the infusion site.
• Elevated blood pressure that resolves after completion.

Serious

• Allergic or anaphylactic reactions, including urticaria, bronchospasm, or hypotension.
• Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.
• Hemolysis or renal impairment.
• Transmission‑related infections (theoretical risk from plasma‑derived products).

Use of Haemocomplettan requires careful assessment of patient history and monitoring during and after administration.

• Verify fibrinogen level and indication before infusion.
• Monitor for signs of hypersensitivity throughout the infusion and for at least 30 minutes after completion.
• Assess risk factors for thrombosis, especially in patients with cardiovascular disease or prolonged immobilization.
• Use caution in patients with known plasma protein allergies or a history of severe transfusion reactions.
• Consider renal and hepatic function, as impairment may affect clearance.
• Avoid use in patients with active disseminated intravascular coagulation unless benefits outweigh risks.

Haemocomplettan may interact with other agents that affect coagulation or increase immunologic risk.

Avoid

• Concurrent administration of pro‑coagulant drugs (e.g., activated factor VII) that could potentiate thrombosis.
• Other plasma‑derived products without appropriate monitoring of fibrinogen levels.

Use with caution

• Antifibrinolytic agents such as tranexamic acid, which may increase clot stability.
• Heparin or low‑molecular‑weight heparin, requiring careful monitoring of coagulation parameters.
• Immunosuppressive therapies that could mask allergic reactions.
• High‑dose vitamin K antagonists, as rapid fibrinogen replacement may alter INR targets.