Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vectibix

Vectibix 20 mg/mL concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 8–9

HOS-117403 · Präparat HOS-094601

8  Adverse reactions MedDRA Very common Common Uncommon system organ (≥ 1/10) (≥ 1/100 to < 1/10) (≥ 1/1 000 to class < 1/100) Gastrointestinal Diarrhoea1 Rectal haemorrhage Chapped lips disorders Nausea Dry mouth Dry lips Vomiting Dyspepsia Abdominal pain Aphthous ulcer Stomatitis Cheilitis Constipation Gastro-oesophageal reflux disease Skin and Dermatitis acneiform Skin ulcer Toxic epidermal subcutaneous Rash Skin exfoliation necrolysis1,4 tissue disorders1 Erythema Exfoliative rash Stevens-Johnson Pruritus Dermatitis syndrome1,4 Dry skin Rash papular Skin necrosis1,4 Skin fissures Rash pruritic Angioedema1 Acne Rash erythematous Hirsutism Alopecia Rash generalised Ingrowing nail Rash macular Onycholysis Rash maculo-papular Skin lesion Skin toxicity Scab Hypertrichosis Onychoclasis Nail disorder Hyperhidrosis Palmar-plantar erythrodysaesthesia syndrome Musculoskeletal Back pain Pain in extremity and connective tissue disorders General Fatigue Chest pain disorders and Pyrexia Pain administration Asthenia Chills site conditions Mucosal inflammation Oedema peripheral Investigations Weight decreased Blood magnesium decreased Injury, Infusion-related poisoning and reaction1 procedural complications 1 See section “Description of selected adverse reactions” below 2 See section 4.4 Infusion-related reactions 3 See section 4.4 Pulmonary complications 4 Skin necrosis, Stevens-Johnson syndrome, toxic epidermal necrolysis and ulcerative keratitis are panitumumab ADRs that were reported in the post-marketing setting. For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting. The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2 224 (or 0.13%).

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