Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tyverb

Tyverb 250 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9–10

HOS-208948 · Präparat HOS-154213

9  Immune system disorders Rare Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia Psychiatric disorders Very common Insomnia* Nervous system disorders Very common Headache† Common Headache* Cardiac disorders Common Decreased left ventricular ejection fraction (see section 4.2 - dose reduction – cardiac events and section 4.4). Not known Ventricular arrhythmias/Torsades de Pointes, electrocardiogram QT prolonged** Vascular disorders Very common Hot flush† Respiratory, thoracic and mediastinal disorders Very common Epistaxis†, cough†, dyspnoea†. Uncommon Interstitial lung disease/pneumonitis. Not known Pulmonary arterial hypertension**. Gastrointestinal disorders Very common Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction – other toxicities and section 4.4), nausea, vomiting, dyspepsia*, stomatitis*, constipation*, abdominal pain*. Common Constipation† Hepatobiliary disorders Common Hyperbilirubinaemia, hepatotoxicity (see section 4.4). Skin and subcutaneous tissue disorders Very common Rash (including dermatitis acneiform) (see section 4.2 - dose delay and dose reduction – other toxicities), dry skin*†, palmar-plantar erythrodysaesthesia*, alopecia†, pruritus†. Common Nail disorders including paronychia, skin fissures. Not known Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*†, back pain*†, arthralgia†. General disorders and administration site conditions Very common Fatigue, mucosal inflammation*, asthenia†. * These adverse reactions were observed when lapatinib was administered in combination with capecitabine. † These adverse reactions were observed when lapatinib was administered in combination with letrozole. ** Adverse reactions from spontaneous reports and literature

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