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Abatacept
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Eintrag öffnenNulojix · 4.1 Therapeutic indications · 1
Eintrag öffnenNulojix · 4.3 Contraindications · 1
Eintrag öffnenNulojix · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Eintrag öffnenNulojix · 4.3 · Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
Eintrag öffnenNulojix · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenNulojix · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenNulojix · 4.5 · Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) an
Eintrag öffnenNulojix · 4.5 · Belatacept is not expected to interrupt the enterohepatic recirculation of MPA. At a given dose of MMF, MPA ex
Eintrag öffnenNulojix · 4.5 · Immunosuppressant therapy may affect response to vaccination. Therefore, during treatment with belatacept, vac
Eintrag öffnenNulojix · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenNulojix · 4.8 Undesirable effects · 1
Eintrag öffnenNulojix · 4.8 · 10 Reproductive system and breast disorders Uncommon epididymitis, priapism, cervical dysplasia, breast mass,
Eintrag öffnenNulojix · 4.8 · 11 Table 3: Malignancies occurring by treatment group (%) Up to Year 1 Up to Year 3*,** Belatacept Belatacept
Eintrag öffnenNulojix · 4.8 · 12 Within the belatacept clinical program, there were 2 patients diagnosed with PML. One fatal case of PML was
Eintrag öffnenNulojix · 4.8 · 13 compared to placebo infusions, there were no differences in event rates (placebo infusions were administere
Eintrag öffnenNulojix · 4.8 · 8 Table 2: Adverse reactions in newly transplanted patient clinical trials Infections and infestations Very Co
Eintrag öffnenNulojix · 4.8 · 9 Eye disorders Common cataract, ocular hyperaemia, vision blurred Uncommon retinitis, conjunctivitis, eye inf
Eintrag öffnenNulojix · 4.8 · A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept. In the individual
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