Lonoctocog alfa

In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.

Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available. Therefore, factor VIII should be used during pregnancy if clearly indicated.

Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during breast-feeding is not available. Therefore, factor VIII should be used during lactation only if clearly indicated.

Lonoctocog alfa has no 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, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with the use of factor VIII products and may in some cases progress to severe anaphylaxis (including shock).

Development of neutralizing antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with lonoctocog alfa. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.

List of adverse reactions

The list presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). The frequencies in the list below were observed in completed clinical studies in previously treated patients with severe haemophilia A.

Frequencies have been evaluated on a per patient basis 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).

Blood and lymphatic system disorders

Uncommon (PTPs)* / Very common (PUPs)*: FVIII inhibition

Immune system disorders

Common: Hypersensitivity

Nervous system disorders

Common: Dizziness, Paraesthesia

Skin and subcutaneous tissue disorders

Common: Rash

Uncommon: Erythema, Pruritus

General disorders and administration site conditions

Common: Pyrexia

Uncommon: Injection site pain, Chills, Feeling hot

* Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.

Paediatric population

No age-specific differences in adverse reactions were observed between paediatric and adult subjects.