Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Abraxane

Abraxane 5 mg/ml powder for dispersion for infusion. · Abschnitt 4.8 · PDF-Seite 12–13

HOS-117876 · Präparat HOS-094711

12  Monotherapy (N = 789) Combination therapy Combination therapy with gemcitabine with carboplatin (N = 421) (N = 514) Skin and subcutaneous tissue disorders Very Alopecia, rash Alopecia, rash Alopecia, rash common: Pruritus, dry skin, nail disorder, Pruritus, dry skin, nail Pruritus, nail disorder erythema, nail disorder Common: pigmentation/discolouration, skin hyperpigmentation, onycholysis, nail changes Photosensitivity reaction, urticaria, skin Skin exfoliation, pain, generalised pruritus, pruritic rash, dermatitis allergic, skin disorder, pigmentation disorder, urticaria hyperhidrosis, onychomadesis, erythematous rash, generalised rash, Uncommon: dermatitis, night sweats, maculo-papular rash, vitiligo, hypotrichosis, nail bed tenderness, nail discomfort, macular rash, papular rash, skin lesion, swollen face Stevens-Johnson syndrome1, toxic Very rare: epidermal necrolysis1 Palmar-plantar erythrodysaesthesiae Not known: syndrome1, 4, scleroderma1 Musculoskeletal and connective tissue disorders Very Arthralgia, myalgia Arthralgia, myalgia, pain Arthralgia, myalgia common: in extremity Back pain, pain in extremity, bone pain, Muscular weakness, bone Back pain, pain in Common: muscle cramps, limb pain pain extremity, musculoskeletal pain Chest wall pain, muscular weakness, neck pain, groin pain, muscle spasms, Uncommon: musculoskeletal pain, flank pain, limb discomfort, muscle weakness Renal and urinary disorders Common: Acute renal failure Haematuria, dysuria, pollakiuria, Haemolytic uraemic Uncommon: nocturia, polyuria, urinary incontinence syndrome Reproductive system and breast disorders Uncommon: Breast pain General disorders and administration site conditions Very Fatigue, asthenia, pyrexia Fatigue, asthenia, pyrexia, Fatigue, asthenia, oedema common: oedema peripheral, chills peripheral Malaise, lethargy, weakness, peripheral Infusion site reaction Pyrexia, chest pain oedema, mucosal inflammation, pain, Common: rigors, oedema, decreased performance status, chest pain, influenza-like illness, hyperpyrexia Chest discomfort, abnormal gait, Mucosal inflammation, swelling, injection site reaction infusion site Uncommon: extravasation, infusion site inflammation, infusion site rash Rare: Extravasation

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