VeraSeal

What it is

VeraSeal is a two-component fibrin sealant made of frozen sterile solutions of human fibrinogen and human thrombin produced from the plasma of human donors. The fibrinogen component contains 80 mg/mL and the thrombin component contains 500 IU/mL. The fibrin adhesion system initiates the last phase of physiological blood coagulation; thrombin cleaves fibrinogen into fibrin monomers and fibrinopeptides, and the fibrin monomers aggregate and form a fibrin clot.

Approved indications

VeraSeal is used as supportive treatment in adults and children where standard surgical techniques are insufficient for improvement of hemostasis and as suture support in vascular surgery. — Improvement of hemostasis in adults and children where standard surgical techniques are insufficient. — Suture support in vascular surgery in adults and children where standard surgical techniques are insufficient.

Dosing overview

The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient, governed by variables including the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications. In clinical trials, the individual dosages have typically ranged from 0.3 to 12 mL. In the paediatric clinical trial, the individual dose ranged from 0.6 to 12 mL with a median dose of 4.8 mL.

Key safety warnings

Life-threatening thromboembolic complications may occur if VeraSeal is administered intravascularly. Inadvertent intravascular injection of VeraSeal could lead to thromboembolic events and disseminated intravascular coagulation (DIC). VeraSeal is made from pooled human plasma which may contain infectious agents, such as viruses, that can cause disease. This product is prepared from large pools of human plasma and may carry a risk of transmitting infectious agents, including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob (CJD) agent. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19, which infection may be serious for pregnant women (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (for example, haemolytic anaemia). As with any protein product, allergic type hypersensitivity reactions are possible; signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. Injection into the nasal mucosa must be avoided, as severe allergic/anaphylactoid reactions have been observed and thromboembolic complications may occur in the area of the ophthalmic artery.

Contraindications

VeraSeal must not be applied intravascularly. VeraSeal must not be used in patients with hypersensitivity to the active substance or to any of the excipients. VeraSeal must not be used for the treatment of severe or brisk arterial bleeding.

Regulatory history

VeraSeal was first approved on 2 November 2021. ARTG 335950 for the 2 mL strength was registered on 2 November 2021, and ARTG registrations for the 4 mL, 6 mL and 10 mL strengths were registered on 3 November 2021, all in licence category RE (Restricted to named patient supply or supply on prescription without recourse to PBAC).