Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Nulojix

NULOJIX 250 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 12–13

HOS-213633 · Präparat HOS-155150

12 Within the belatacept clinical program, there were 2 patients diagnosed with PML. One fatal case of PML was reported in a renal transplant recipient treated with belatacept MI regimen, an IL-2 receptor antagonist, MMF, and corticosteroids for 2 years in a Phase 3 trial. The other case of PML was reported in a liver transplant recipient in a Phase 2 trial who received 6 months of treatment with an augmented belatacept MI regimen, MMF at doses higher than the recommended dose and corticosteroids (see section 4.4).

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