Experience regarding the use of susoctocog alfa during pregnancy is not available. Therefore, susoctocog alfa should be used during pregnancy only if clearly indicated.
Experience regarding the use of susoctocog alfa during breast-feeding is not available. Therefore, susoctocog alfa should be used during lactation only if clearly indicated.
Animal reproduction studies have not been conducted with susoctocog alfa.
Susoctocog 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, 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).
Patients with acquired haemophilia may develop inhibitory antibodies to porcine Factor VIII.
The list presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). In the clinical trial of susoctocog alfa 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).
Common: Positive test for inhibitory antibodies against porcine Factor VIII
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