Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Jivi

Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection Jivi 4000 IU powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 10

HOS-134333 · Präparat HOS-097550

Anti-PEG antibodies Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observed in 2 patients. In one patient > 12 years of age, the immune response was accompanied by a clinical hypersensitivity reaction after 4 injections of Jivi. Antibodies to PEG disappeared after discontinuation of Jivi. One child ˃ 7 years, developed high titre neutralising anti-PEG IgM antibodies within the first 4 exposure days associated with loss of drug effect. Antibodies disappeared after discontinuation and patient safely re-started treatment with Jivi 2 months later. Transient low titre anti-PEG antibodies of the IgM isotype were observed in some patients within the first 4 ED resulting in minor reduction of recovery.

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