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Bavencio
Eintrag öffnenBavencio · 4.1 Therapeutic indications · 1
Eintrag öffnenBavencio · 4.3 Contraindications · 1
Eintrag öffnenBavencio · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenBavencio · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenBavencio · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenBavencio · 4.5 · Avelumab is primarily metabolised through catabolic pathways, therefore, it is not expected that avelumab will
Eintrag öffnenBavencio · 4.5 · No interaction studies have been conducted with avelumab.
Eintrag öffnenBavencio · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenBavencio · 4.8 Undesirable effects · 1
Eintrag öffnenBavencio · 4.8 · 10 The most common Grade ≥ 3 adverse reactions were anaemia (5.6%), hypertension (3.9%), hyponatraemia (3.6%),
Eintrag öffnenBavencio · 4.8 · 11 Frequency Adverse reactions Gastrointestinal disorders Very common Nausea, diarrhoea, constipation, vomitin
Eintrag öffnenBavencio · 4.8 · 12 In this patient population, the most common adverse reactions were diarrhoea (62.8%), hypertension (49.3%),
Eintrag öffnenBavencio · 4.8 · 13 Frequency Adverse reactions Hepatobiliary disorders Common Hepatic function abnormal* Uncommon Hepatitis*,
Eintrag öffnenBavencio · 4.8 · 14 In patients treated with avelumab in combination with axitinib, 0.6% (3/489) of patients developed immune-m
Eintrag öffnenBavencio · 4.8 · 15 The median time to onset of immune-mediated colitis was 5.1 months (range: 2.3 weeks to 14 months). The med
Eintrag öffnenBavencio · 4.8 · 16 In patients treated with avelumab in combination with axitinib, 1.8% (9/489) of patients developed immune-m
Eintrag öffnenBavencio · 4.8 · 17 Immune-mediated nephritis did not lead to discontinuation of avelumab in any patient. All 2 patients with i
Eintrag öffnenBavencio · 4.8 · Adrenal insufficiency In patients treated with avelumab as monotherapy, 0.5% (11/2 082) of patients developed
Eintrag öffnenBavencio · 4.8 · Adverse reactions reported for 489 patients with advanced RCC treated in two clinical studies or reported from
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