Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Opdivo

OPDIVO 10 mg/mL concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 32–33

HOS-133367 · Präparat HOS-097426

32  Combination with Combination with Combination with ipilimumab (with or chemotherapy cabozantinib without chemotherapy) Musculoskeletal and connective tissue disorders Very common musculoskeletal painf, musculoskeletal painf musculoskeletal painf, arthralgia arthralgia, muscle spasm Common muscle spasms, muscular arthralgia, muscular arthritis weakness, arthritis weakness Uncommon polymyalgia rheumatica, myopathy, osteonecrosis of myopathy, myositis the jaw, fistula (including polymyositis)a Rare spondyloarthropathy, Sjögren's syndrome, rhabdomyolysisa Renal and urinary disorders Very common proteinuria a Common renal failure (including renal failure renal failure, acute kidney acute kidney injury)a injury Uncommon tubulointerstitial nephritis, cystitis noninfective, nephritis nephritis nephritis Rare cystitis noninfective cystitis noninfectiveh General disorders and administration site conditions Very common fatigue, pyrexia, oedema fatigue, pyrexia, oedema fatigue, pyrexia, oedema (including peripheral (including peripheral oedema) oedema) Common chest pain, pain, chills malaise pain, chest pain Investigations Very common increased alkaline hypocalcaemiab, increased alkaline phosphataseb, increased increased AST b, phosphataseb, increased ALTb, ASTb, increased ALTb, increased ALT b, increased ASTb, increased increased total bilirubinb, hyponatraemiab, total bilirubinb, increased increased creatinineb, increased amylaseb, creatinineb, increased increased amylaseb, hypomagnesaemiab, amylaseb, increased lipaseb, increased lipaseb, increased alkaline hypokalaemiab, hyponatraemiab, phosphataseb, hypomagnesaemiab, hyperkalaemiab, hypokalaemiab, increased hyponatraemiab, hypokalaemiab, creatinineb, increased hypocalcaemiab, hypercalcaemiab, lipaseb, hyperkalaemiab, hypercalcaemiab, hypocalcaemiab, increased total bilirubinb hypophosphataemiab, hypomagnesaemiab hyperkalaemiab, hypermagnesaemiab, hypernatraemiab Common hypernatraemiab, hypernatraemiab, blood cholesterol increased, hypermagnesaemiab, hypercalcaemiab, hypertriglyceridaemia increased thyroid hypermagnesaemiab stimulating hormone, increased gamma- glutamyltransferase Adverse reaction frequencies presented in Table 19 may not be fully attributable to nivolumab alone or in combination with other therapeutic agents, but may contain contributions from the underlying disease or from medicinal product used in combination. a Fatal cases have been reported in completed or ongoing clinical studies. b Frequencies of laboratory terms reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements. See “Description of selected adverse reactions; laboratory abnormalities” below. c Rash is a composite term which includes maculopapular rash, rash erythematous, rash pruritic, rash follicular, rash macular, rash morbilliform, rash papular, rash pustular, rash papulosquamous, rash vesicular, rash generalised, exfoliative rash, dermatitis, dermatitis acneiform, dermatitis allergic, dermatitis atopic, dermatitis bullous, dermatitis exfoliative, dermatitis psoriasiform, drug eruption, nodular rash, and pemphigoid.

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