Efanesoctocog alfa interacts in the following cases:
In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
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 only 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.
Animal reproduction studies have not been conducted with factor VIII.
Efanesoctocog alfa has no or negligible influence on the ability to drive and use machines.
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 and may in some cases progress to severe anaphylaxis (including shock).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with efanesoctocog 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.
Table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies of adverse reactions are based on Phase 3 clinical studies in 277 previously treated patients (PTPs) with severe haemophilia A, of which 161 (58.2%) were adults (18 years of age and older), 37 (13.4%) were adolescents (12 to <18 years of age), and 79 (28.5%) were children under the age of 12 years.
Adverse drug reactions (ADRs) (summarized in the table) were reported in 111 (40.1%) of the 277 subjects treated with routine prophylaxis or on-demand therapy.
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).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Adverse reactions reported for efanesoctocog alfa in clinical studies:
| MedDRA system organ class | Adverse reactions | Frequency category |
|---|---|---|
| Nervous system disorders | Headache1 | Very common |
| Gastrointestinal disorders | Vomiting | Common |
| Skin and subcutaneous tissue disorders | Eczema | Common |
| Rash2 | Common | |
| Urticaria3 | Common | |
| Musculoskeletal and connective tissue disorders | Arthralgia | Very common |
| Pain in extremity | Common | |
| Back pain | Common | |
| General disorders and administration site conditions | Pyrexia | Common |
| Injection site reaction4 | Uncommon |
1 Headache, including migraine.
2 Rash, including rash maculo papular.
3 Urticaria, including urticaria papular.
4 Injection site reaction, including injection site haematoma and injection site dermatitis.
No age-specific differences in adverse reactions were observed between paediatric and adult patients.
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