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Carvykti
Eintrag öffnenCarvykti · 4.1 Therapeutic indications · 1
Eintrag öffnenCarvykti · 4.3 Contraindications · 1
Eintrag öffnenCarvykti · 4.3 · Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Contraindicatio
Eintrag öffnenCarvykti · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenCarvykti · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenCarvykti · 4.5 · Live vaccines The safety of immunisation with live viral vaccines during or following CARVYKTI treatment has n
Eintrag öffnenCarvykti · 4.5 · No pharmacokinetic or pharmacodynamic drug interaction studies have been performed with CARVYKTI.
Eintrag öffnenCarvykti · 4.5 · Some patients in the clinical trials on CARVYKTI required tocilizumab, corticosteroids and anakinra for manage
Eintrag öffnenCarvykti · 4.5 · The co-administration of agents known to inhibit T cell function has not been formally studied. The co-adminis
Eintrag öffnenCarvykti · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenCarvykti · 4.8 Undesirable effects · 1
Eintrag öffnenCarvykti · 4.8 · 14 The most common (≥5%) Grade ≥ 3 non-haematological adverse reactions were transaminase elevation (11%), pne
Eintrag öffnenCarvykti · 4.8 · 15 Personality changes8 3 1 Nervous system disorders Very common Encephalopathy9# 14 3 Immune effector cell-as
Eintrag öffnenCarvykti · 4.8 · 16 Adverse reactions are reported using MedDRA version 26.1 # Contains fatal outcome(s). * Based on grouped te
Eintrag öffnenCarvykti · 4.8 · 17 Description of selected adverse reactions
Eintrag öffnenCarvykti · 4.8 · 18 Cranial nerve palsies In the pooled studies (N=396), 27 patients experienced cranial nerve palsies. Median
Eintrag öffnenCarvykti · 4.8 · 19 treatment-emergent anti-CAR antibodies. There was no clear evidence that the observed anti-CAR antibodies i
Eintrag öffnenCarvykti · 4.8 · Cytokine release syndrome CRS was reported in 83% of patients (n=330); 79% (n=314) of patients had CRS events
Eintrag öffnenCarvykti · 4.8 · Guillain-Barré syndrome In the pooled studies (N=396), one patient was reported to have GBS after treatment wi
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