Octaplex Adverse Reactions

Summary of Safety Profile: Replacement therapy may lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response.
Allergic or anaphylactic-type reactions may rarely occur (≥1/10,000 to <1/1,000), including severe anaphylactic reactions.
Increase in body temperature has been observed very rarely (<1/10,000).
There is a risk of thromboembolic episodes following the administration of human prothrombin complex (see Precautions).
Tabulated List of Adverse Reactions of Octaplex: The table presented as follows is according to the MedDRA system organ classification (SOC and Preferred Term Level). Frequencies have been based on clinical trial data, 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) or not known (cannot be estimated from the available data). (See Table 4.)

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The following adverse reactions have been reported during post-marketing use of Octaplex. Because post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions. (See Table 5.)

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Octaplex contains heparin. Therefore, a sudden, allergy induced reduction of the blood platelet count below 100,000/μl or 50% of the starting count may be rarely observed (thrombocytopenia type II). In patients not previously hypersensitive to heparin, this decrease in thrombocytes may occur 6-14 days after the start of treatment. In patients with previous heparin hypersensitivity, this reduction may happen within a few hours. The treatment with Octaplex must be stopped immediately in patients showing this allergic reaction. These patients must not receive heparin containing medicinal products in the future.
For safety with respect to transmissible agents, see Precautions.
Paediatric population: No data are available regarding the use of Octaplex in paediatric population.
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.