Human fibrinogen

If allergic or anaphylactic-type reactions occur, the injection/infusion should be stopped immediately. In case of anaphylactic shock, standard medical treatment for shock should be implemented.

There is a risk of thrombosis when patients with congenital deficiency are treated with human fibrinogen concentrate, particularly with high dose or repeated dosing. Patients given human fibrinogen concentrate should be observed closely for signs or symptoms of thrombosis.

In patients with a history of coronary heart disease or myocardial infarction, in patients with liver disease, in peri- or post-operative patients, in neonates, or in patients at risk of thromboembolic events or disseminated intravascular coagulation, the potential benefit of treatment with human plasma fibrinogen concentrate should be weighed against the risk of thromboembolic complications. Caution and close monitoring should also be performed.

Animal reproduction studies have not been conducted with human fibrinogen. Since the active substance is of human origin, it is catabolised in the same manner as the patient’s own protein. These physiological constituents of the human blood are not expected to induce adverse effects on reproduction or on the foetus.

The safety of human fibrinogen for use in human pregnancy has not been established in controlled clinical trials.

Clinical experience with fibrinogen concentrate in the treatment of obstetric complications suggests that no harmful effects on the course of the pregnancy or health of the foetus or the neonate are to be expected.

It is unknown whether human fibrinogen is excreted in human milk. The use of human fibrinogen in lactating women has not been investigated in clinical trials.

A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from human fibrinogen therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on fertility available.

Human fibrinogen has no or negligible influence on the ability to drive and use machines.

List of adverse drug reactions (ADRs)

The table combines the adverse reactions identified from clinical trials and post-marketing experience.

Frequencies presented in the table have been based on pooled analyses across two company sponsored, placebo-controlled clinical trials performed in aortic surgery with or without other surgical procedures [BI3023-2002 (N=61) and BI3023_3002 (N=152)] according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

For spontaneous post-marketing ADRs, the reporting frequency is categorised as ‘Unknown’. In view of the fact that these trials were conducted in only the narrow population of aortic surgery, adverse drug reaction rates observed in these trials may not reflect the rates observed in clinical practice and are unknown for clinical settings outside the studied indication.

General Disorders and Administration Site Condition

Very common: Pyrexia

Immune System Disorder

Uncommon: Anaphylactic reactions (including anaphylactic shock)

Unknown: Allergic reactions (including generalised urticaria, rash, dyspnoea, tachycardia, nausea, vomiting, chills, pyrexia, chest pain, cough, blood pressure decreased)

Vascular Disorder

Common**: Thromboembolic events*

* Isolated cases have been fatal.
** Based on results of two clinical trials (aortic surgery with or without other surgical procedures), the pooled incidence rate of thromboembolic events was lower in fibrinogen treated subjects (N=8, 7.4%) compared with placebo (N=11, 10.4%).