Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tysabri

Tysabri 150 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 34

HOS-113998 · Präparat HOS-094001

In 2-year controlled clinical trials in MS patients, treatment with natalizumab was associated with increases in circulating lymphocytes, monocytes, eosinophils, basophils and nucleated red blood cells. Elevations in neutrophils were not seen. Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges with intravenous infusion administration. During treatment with this medicinal product, small reductions in haemoglobin (mean decrease 0.6 g/dL), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/L) were seen. All changes in haematological variables returned to pre-treatment values, usually within 16 weeks of last dose of the medicinal product and the changes were not associated with clinical symptoms. In post-marketing experience, there have also been reports of eosinophilia (eosinophil count > 1 500/mm3) without clinical symptoms. In such cases where therapy was discontinued the elevated eosinophil levels resolved.

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