Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Traceability
In order to improve traceability of biological medicinal products, the name of the administered product should be clearly recorded. It is recommended to record the batch number as well.

Hypersensitivity
Allergic type hypersensitivity reactions are possible with Refixia. 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 (rDNA) products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.

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 administrations 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.

In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing. Therefore a pre-heating step or a wash-out is recommended in order to ensure detection of low-titre inhibitors.

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 Refixia should be weighed against the risk of these complications.

Cardiovascular event
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.

Children and adolescents
The listed warnings and precautions apply both to adults and children.

Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”. In case of treatment with multiple vials, the total sodim content should be taken into consideration.

Effects on Driving

4.7   Effects on ability to drive and use machines

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