Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity
Allergic type hypersensitivity reactions are possible with IDELVION. The product contains traces of hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
In case of shock, standard medical treatment for shock should be implemented.

Inhibitors
After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing. Formation of inhibitor to factor IX has been reported during factor replacement therapy with IDELVION in the treatment of haemophilia B.

There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.

Because of the risk of allergic reactions with factor IX products, the initial administration of factor IX should, according to the treating physician’s judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.

Thromboembolism
Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC. In each of these situations, the benefit of treatment with IDELVION should be weighed against the risk of these complications.

Cardiovascular events
In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.

Catheter-related complications
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.

Elderly
Clinical studies of IDELVION did not include subjects aged 65 and over. It is not known whether they respond differently from younger subjects.

Immune tolerance induction
The safety and efficacy of using IDELVION for immune tolerance induction has not been established.

Sodium content
This medicinal product contains up to 8.6 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult.


Paediatric population
The listed warnings and precautions apply both to adults and children.

Effects on Driving

4.7   Effects on ability to drive and use machines

IDELVION has no influence on the ability to drive and use machines.