Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Kimmtrak

KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9–10

HOS-142907 · Präparat HOS-098902

9  Nervous system disorders Very common Headache2 , dizziness, paraesthesia Common Taste disorder Cardiac disorders Very common Tachycardia2 Common Arrhythmia2, atrial fibrillation2 Uncommon Angina pectoris2, cardiac failure2 Vascular disorders Very common Hypotension2, flushing, hypertension Respiratory, thoracic and mediastinal disorders Very common Cough, dyspnoea Common Oropharyngeal pain, hypoxia2 Gastrointestinal disorders Very common Nausea2, vomiting2, diarrhoea, abdominal pain, constipation, dyspepsia Skin and subcutaneous tissue disorders Very common Rash, pruritus, dry skin, hypo/ hyperpigmentation4, erythema Common Alopecia, night sweats Musculoskeletal and connective tissue disorders Very common Arthralgia, back pain, myalgia, pain in extremity Common Muscle spasm General disorders and administration site conditions Very common Pyrexia2, fatigue3, chills2, oedema5, Influenza like illness Investigations Very common Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, lipase increased, anaemia, lymphocyte count decreased, blood phosphate decreased, blood creatinine increased Common Amylase increased, gamma glutamyltransferase increased, white blood cell count increased, blood alkaline phosphatase increased, blood glucose increased Uncommon Electrocardiogram QT prolonged 1 CRS was adjudicated using the ASTCT consensus grading of CRS criteria (Lee et.al 2019). Adjudicated CRS is provided in lieu of investigator reported CRS. 2 Some of the events may be associated with CRS or may be isolated reported events. 3 Includes fatigue and asthenia. 4 Includes achromotrichia acquired, ephelides, eyelash discolouration, eyelash hypopigmentation, hair colour changes, lentigo, pigmentation disorder, retinal depigmentation, skin depigmentation, skin discolouration, skin hyperpigmentation, skin hypopigmentation, solar lentigo, vitiligo. 5 Includes eye oedema, eye swelling, eyelid oedema, periorbital swelling, periorbital oedema, swelling of eyelid, pharyngeal oedema, lip oedema, lip swelling, face oedema, generalized oedema, localized oedema, oedema, oedema peripheral, peripheral swelling, swelling, swelling face.

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