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Human medicines European public assessment report (EPAR): Jivi, damoctocog alfa pegol, Hemophilia A, Date of authorisation: 22/11/2018, Revision: 5, Status: Authorised

The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache. Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing. In some cases these reactions can become severe.

Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.

Jivi must not be used in patients with allergy to mouse or hamster proteins. For the full list of side effects and restrictions, see the package leaflet.

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