Haemocomplettan P (Human Fibrinogen)

Haemocomplettan P is indicated for the management of patients who have low fibrinogen concentrations that increase bleeding risk.

• Replacement therapy in congenital fibrinogen deficiency (afibrinogenemia, hypofibrinogenemia).
• Treatment of acquired fibrinogen deficiency during massive hemorrhage, such as trauma or surgery.
• Supportive care for bleeding associated with disseminated intravascular coagulation when fibrinogen levels are critically low.
• Peri‑operative fibrinogen supplementation in cardiac or liver transplantation procedures.
• Management of bleeding in obstetric hemorrhage when fibrinogen depletion is documented.

Adverse reactions reported with Haemocomplettan P are generally related to the infusion process or to the protein nature of the product. These events are monitored during and after administration.

Common

• Mild fever or chills during or shortly after infusion.
• Headache or dizziness.
• Nausea or vomiting.
• Transient hypotension or mild hypertension.
• Localized infusion site erythema or swelling.
• Transient tachycardia or palpitations.

Serious

• Allergic or anaphylactic reactions, including urticaria, bronchospasm, or angioedema.
• Thromboembolic events such as deep‑vein thrombosis or pulmonary embolism.
• Severe hypotension or cardiovascular collapse.
• Hemolysis or renal impairment secondary to immune complex formation.
• Disseminated intravascular coagulation exacerbation.

When using Haemocomplettan P, clinicians should consider several precautionary measures to minimize risk and ensure appropriate patient selection.

• Verify fibrinogen level and clinical indication before initiating therapy.
• Assess for a history of hypersensitivity to blood products or fibrinogen concentrates.
• Monitor vital signs and coagulation parameters during and after infusion.
• Use caution in patients with active thrombotic disease or a high risk of thrombosis.
• Adjust dosing in individuals with renal or hepatic impairment as guided by laboratory values.
• Avoid rapid infusion rates; follow recommended administration speed.
• Document product lot number and traceability for pharmacovigilance.

Haemocomplettan P may interact with other agents that affect coagulation or immune response, requiring careful management.

Avoid

• Concomitant use of pro‑thrombotic agents (e.g., activated factor VII, prothrombin complex concentrates) without clear indication.
• Simultaneous administration of other plasma‑derived fibrinogen products.

Use with caution

• Antifibrinolytic drugs such as tranexamic acid, which may increase clot stability.
• Anticoagulants (heparin, direct oral anticoagulants) that could alter the balance between bleeding and thrombosis.
• Immunosuppressive therapies that may mask allergic reactions.
• High‑dose steroids, which could affect immune response to the protein.