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Columvi
Eintrag öffnenColumvi · 4.1 Therapeutic indications · 1
Eintrag öffnenColumvi · 4.3 Contraindications · 1
Eintrag öffnenColumvi · 4.3 · For specific contraindications on obinutuzumab, please refer to the obinutuzumab prescribing information.
Eintrag öffnenColumvi · 4.3 · Hypersensitivity to the active substance, to obinutuzumab, or to any of the excipients listed in section 6.1.
Eintrag öffnenColumvi · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenColumvi · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenColumvi · 4.5 · No interaction studies have been performed. No interactions with Columvi are expected via the cytochrome P450
Eintrag öffnenColumvi · 4.5 · The initial release of cytokines associated with the start of Columvi treatment could suppress CYP450 enzymes.
Eintrag öffnenColumvi · 4.5 · The pharmacokinetics (PK) of glofitamab are not affected by co-administration with gemcitabine or oxaliplatin.
Eintrag öffnenColumvi · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenColumvi · 4.8 Undesirable effects · 1
Eintrag öffnenColumvi · 4.8 · 15 Adverse reactions occurring in relapsed or refractory DLBCL patients treated with Columvi in combination wi
Eintrag öffnenColumvi · 4.8 · 16 System organ class Adverse reaction All grades Grade 34
Eintrag öffnenColumvi · 4.8 · 17 Table 7. Adverse reactions reported in patients with relapsed or refractory DLBCL treated with Columvi in c
Eintrag öffnenColumvi · 4.8 · 18 System organ class Adverse reaction All grades Grade 34
Eintrag öffnenColumvi · 4.8 · 19 were no fatal cases of CRS. CRS resolved in all patients except one. One patient discontinued treatment due
Eintrag öffnenColumvi · 4.8 · 20 18.4 hours (range: 8.3 to 137.0 hours). CRS was reported in 6.7% of patients at Cycle 3 and in 11.0% of pat
Eintrag öffnenColumvi · 4.8 · 21 Colitis Colitis (Grade 4) was reported in 1 patient (0.7%) who received Columvi monotherapy, with time to o
Eintrag öffnenColumvi · 4.8 · Adverse reactions occurring in relapsed or refractory DLBCL patients treated with Columvi monotherapy (n=145)
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