Chemical formula: C₂₁H₄₀N₄O₁₀ Molecular mass: 508.274 g/mol
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.
Rurioctocog alfa pegol has no 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 rurioctocog alfa pegol. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.
The safety of rurioctocog alfa pegol was evaluated in 243 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of rurioctocog alfa pegol in 3 completed multi-center, prospective, open label clinical studies and 2 ongoing clinical studies. The median number of exposure days to rurioctocog alfa pegol per subject was 103.5 (min-max: 1-278).
The list presented below is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
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 rurioctocog alfa pegol:
Uncommon (PTPs)*: Factor VIII inhibition
Uncommon: Hypersensitivity
Common: Headache
Uncommon: Flushing
Common: Diarrhoea, Nausea
Common: Rash
The observed event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year-old patient who had developed a previous rash while on rurioctocog alfa pegol.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. The safety of rurioctocog alfa pegol was evaluated in 38 subjects <6 years and 34 subjects 6 to <12 years of age having accumulated a total of 2880 EDs and 2975 EDs respectively. The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
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