OBIZUR Powder and solvent for solution for injection Ref.[7646] Active ingredients: Susoctocog alfa

Hypersensitivity

Allergic type hypersensitivity reactions are possible with OBIZUR. The product contains trace amounts 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.

Development of inhibitory antibodies

Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR. Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR. It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay.

There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration. Therefore, OBIZUR must only be administered when considered clinically necessary. Extensive cutaneous purpura do not necessarily require treatment.

OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells. Antibodies to baby hamster kidney cell protein were not detected in subjects after exposure to OBIZUR.

High and sustained Factor VIII activity in blood may predispose to thromboembolic events. Those with pre-existing cardiovascular disease and the elderly are at particular risk.

If venous catheterisation is required, the risk of catheter-related complications such as catheter site thrombosis should be considered.

Factor VIII activity determined by the chromogenic assay is generally lower than Factor VIII activity determined by the one-stage clotting assay. Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient. The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR (see sections 4.2 and 5.2).

Name and batch number

It is strongly recommended that every time that OBIZUR is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.

Sodium content

Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.

To be taken into consideration by patients on a controlled sodium diet.

No interactions of OBIZUR with other medicinal products have been reported.

Animal reproduction studies have not been conducted with OBIZUR. Experience regarding the use of OBIZUR during pregnancy and breast-feeding is not available. Therefore, OBIZUR should be used during pregnancy and lactation only if clearly indicated.

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

Summary of the safety profile

Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) are possible and may progress to severe anaphylaxis (including shock) (see section 4.4).

Patients with acquired haemophilia may develop inhibitory antibodies to porcine Factor VIII.

Tabulated list of adverse reactions

The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). In the clinical trial of OBIZUR for acquired haemophilia, 29 adult subjects were evaluable for safety.

Frequencies have been evaluated 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), not known (cannot be estimated from the available data).

Investigations

Common: Positive test for inhibitory antibodies against porcine Factor VIII (see section 4.4)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.