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Ado-Trastuzumab-Emtansin
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Eintrag öffnenKadcyla · 4.1 Therapeutic indications · 1
Eintrag öffnenKadcyla · 4.3 Contraindications · 1
Eintrag öffnenKadcyla · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenKadcyla · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenKadcyla · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenKadcyla · 4.5 · In vitro metabolism studies in human liver microsomes suggest that DM1, a component of trastuzumab emtansine,
Eintrag öffnenKadcyla · 4.5 · No formal interaction studies have been performed.
Eintrag öffnenKadcyla · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenKadcyla · 4.8 Undesirable effects · 1
Eintrag öffnenKadcyla · 4.8 · 11 Table 3 Tabulated list of ADRs in patients treated with trastuzumab emtansine in clinical studies System Or
Eintrag öffnenKadcyla · 4.8 · 12 Description of selected adverse reactions
Eintrag öffnenKadcyla · 4.8 · 13 Infusion-related reactions Infusion-related reactions are characterised by one or more of the following sym
Eintrag öffnenKadcyla · 4.8 · 14 Haematologic Decreased platelet count 85 14 3 Decreased haemoglobin 63 5 1 Decreased neutrophils 41 4 <1 Po
Eintrag öffnenKadcyla · 4.8 · Extravasation Reactions secondary to extravasation have been observed in clinical studies with trastuzumab emt
Eintrag öffnenKadcyla · 4.8 · Gastrointestinal disorders Very common Stomatitis, Diarrhoea, Vomiting, Nausea, Constipation, Dry mouth, Abdom
Eintrag öffnenKadcyla · 4.8 · Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical studies with trastuzumab em
Eintrag öffnenKadcyla · 4.8 · Hypersensitivity reactions Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with tras
Eintrag öffnenKadcyla · 4.8 · Immunogenicity As with all therapeutic proteins, there is the potential for an immune response to trastuzumab
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