Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Bosulif

Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets Bosulif 50 mg hard capsules Bosulif 100 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17

HOS-125494 · Präparat HOS-096073

Renal disorders In patients with newly-diagnosed- CP CML treated with 400 mg, the median decline from baseline in eGFR (estimated by MDRD Equation) was 11.1 mL/min/1.73 m2 at 1 year and 14.1 mL/min/1.73 m2 at 5 years for patients on-treatment. Treatment-naïve CML patients treated with 500 mg showed a median eGFR decline of 9.2 mL/min/1.73 m2 at 1 year, 12.0 mL/min/1.73 m2 at 5 years and 16.6 mL/min/1.73 m2 at 10 years for patients on-treatment. In pre-treated patients with CP and advanced stage CML treated with 500 mg the median eGFR decline was 7.6 mL/min/1.73 m2 at 1 year, 12.3 mL/min/1.73 m2 at 5 years and 15.9 mL/min/1.73 m2 at 10 years for patients on-treatment. In patients with Ph+ CML previously treated with 1 or more TKI(s) treated with 500 mg, the median eGFR decline from baseline was 9.2 mL/min/1.73 m2 at 1 year and 14.5 mL/min/1.73 m2 at 4 years for patients on-treatment.

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