Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Pomalidomide Teva

Pomalidomide Teva 1 mg hard capsules Pomalidomide Teva 2 mg hard capsules Pomalidomide Teva 3 mg hard capsules Pomalidomide Teva 4 mg hard capsules · Abschnitt 4.8 · PDF-Seite 16–19

HOS-152591 · Präparat HOS-100789

16 Combination of Pomalidomide/ Pomalidomide/ treatment bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Herpes zoster - - Common Uncommon Hepatitis B - - Not known* Not known* reactivation Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma Common Uncommon - - Basal cell - - Uncommon Uncommon carcinoma of the skin Squamous cell - - Uncommon Uncommon carcinoma of the skin Blood and lymphatic system disorders Neutropenia Very common Very common Very common Very common Thrombocytopenia Very common Very common Very common Very common Leucopenia Very common Common Very common Common Anaemia Very common Very common Very common Very common Febrile neutropenia Common Common Common Common Lymphopenia Common Common - - Pancytopenia - - Common* Common* Immune system disorders Angioedema - - Common* Uncommon* Urticaria - - Common* Uncommon* Anaphylactic reaction Not known* Not known* - - Solid organ Not known* - - - transplant rejection Endocrine disorders Hypothyroidism Uncommon* - - -- Metabolism and nutrition disorders Hypokalaemia Very common Common - - Hyperglycaemia Very common Common - - Hypomagnesaemia Common Com - - mon Hypocalcaemia Common Common - - Hypophosphataemia Common Common - - Hyperkalaemia Common Common Common Common Hypercalcaemia Common Common - - Hyponatraemia - - Common Common Decreased appetite - - Very common Uncommon Hyperuricaemia - - Common* Common* Tumour lysis - - Uncommon* Uncommon* 17 Combination of Pomalidomide/ Pomalidomide/ treatment bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs syndrome Psychiatric disorders Insomnia Very common Common - - Depression Common Common - - Confusional state - - Common Common Nervous system disorders Peripheral sensory Very common Common Common Uncommon neuropathy Dizziness Very common Uncommon Common Uncommon Tremor Very common Uncommon Common Uncommon Syncope Common Common - - Peripheral Common Common - - sensorimotor neuropathy Paraesthesia Common - - - Dysgeusia Common - - - Depressed - - Common Common level of consciousn ess Intracranial - - Common* Uncommon* haemorrhage Cerebrovascular - - Uncommon* Uncommon* accident Eye disorders Cataract Common Common - - Ear and labyrinth disorders Vertigo - - Common Common Cardiac disorders Atrial fibrillation Very common Common Common* Common* Cardiac failure - - Common* Common* Myocardial infarction - - Common* Uncommon* Vascular disorders Deep vein thrombosis Common Uncommon Common Uncommon Hypotension Common Common - - Hypertension Common Common - - Respiratory, thoracic and mediastinal disorders Dyspnoea Very common Common Very common Common Cough Very common - Very common Uncommon Pulmonary embolism Common Common Common Uncommon Epistaxis - - Common* Uncommon* 18 Combination of Pomalidomide/ Pomalidomide/ treatment bortezomib/dexamethasone dexamethasone System Organ Class All ADRs Grade 3−4 All ADRs Grade 3−4 /Preferred term ADRs ADRs Interstitial lung disease - - Common* Uncommon* Gastrointestinal disorders Diarrhoea Very common Common Very common Common Vomiting Very common Common Common Common Nausea Very common Uncommon Very common Uncommon Constipation Very common Common Very common Common Abdominal pain Very common Common - - Abdominal pain upper Common Uncommon - - Stomatitis Common Uncommon - - Dry mouth Common - - - Abdominal distension Common Uncommon - - Gastrointestinal - - Common Uncommon haemorrhage Hepatobiliary disorders Hyperbilirubinaemia - - Uncommon Uncommon Hepatitis - - Uncommon* - Skin and subcutaneous tissue disorders Rash Very common Common Common Common Pruritus - - Common - Drug Reaction with - - Not known* Not known* Eosinophilia and Systemic Symptoms Toxic Epidermal - - Not known* Not known* Necrolysis Stevens-Johnson - - Not known* Not known* Syndrome Musculoskeletal and connective tissue disorders Muscular weakness Very common Com - - mon Back pain Very common Common - - Bone pain Common Uncommon Very common Common Muscle spasms Very common - Very common Uncommon Renal and urinary disorders Acute kidney injury Common Common - - Chronic kidney injury Common Common - - Urinary retention Common Common Common Uncommon Renal failure - - Common Common Reproductive system and breast disorders Pelvic pain Common Common General disorders and administration site conditions Fatigue Very common Common Very common Common

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