Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Docetaxel Kabi

DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 208

HOS-215053 · Präparat HOS-155350

Skin and subcutaneous tissue disorders In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%). At the end of the follow-up period (actual median follow-up time of8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2,2%). In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow- up period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.

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