Nebenwirkungen · Carvykti
CARVYKTI 3.2 × 106 – 1 × 108 cells dispersion for infusion · Abschnitt 4.8 · PDF-Seite 19
HOS-144291 · Präparat HOS-099146
Hypogammaglobulinaemia In the pooled studies (N=396), hypogammaglobulinaemia occurred in 34% of patients, with 5% of patients experiencing Grade 3 hypogammaglobulinaemia. Laboratory IgG levels fell below 500 mg/dL after infusion in 91% (360/396) of patients treated with CARVYKTI. Hypogammaglobulinaemia either as an adverse reaction or a laboratory IgG level below 500 mg/dL occurred in 92% (364/396) of patients after infusion. Fifty-eight percent of patients received IVIG post CARVYKTI for either an adverse reaction or prophylaxis. See section 4.4 for monitoring and management guidance.
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