Antineoplastic Agents: Immunotherapeutic Agents
IKADC1 “Kadcyla injection” 100 mg/vial
IKADC2 “Kadcyla injection” 160 mg/vial
適應症：單獨使用時能夠治療 HER2陽性、之前分別接受過trastuzumab與一種taxane藥物治療或其合併療法的轉移性乳癌病患。
Usual dose:
Metastatic breast cancer: 3.6 mg/kg IV infusion every 3 weeks (21-day cycle); infuse first infusion over 90 minutes and subsequent infusions over 30 minutes.
Dose adjustment:
Hepatic impairment: grade 2 hyperbilirubinemia (greater than 1.5 to 3 times ULN), interrupt therapy until recovery to grade 1 or lower, then re-treat with the same dose; grade 3 hyperbilirubinemia (greater than 3 to 10 times ULN), interrupt therapy until recovery to grade 1 or lower, then reduce the dose by 1 level; first dose reduction to 3 mg/kg every 3 weeks or second dose reduction to 2.4 mg/kg every 3 weeks.
Infusion-related reaction: Slow the infusion rate or interrupt the infusion.
Left ventricular ejection fraction (LVEF): 40% to 45% and a decrease of 10% points or greater from baseline, interrupt therapy, repeat LVEF assessment within 3 weeks, if LVEF does not recover to within 10% points from baseline, discontinue therapy; if LVEF is less than 40%, interrupt therapy and repeat LVEF assessment within 3 weeks, if LVEF is confirmed less than 40%, or if the patient develops symptomatic congestive heart failure, discontinue therapy.
Peripheral neuropathy: (grade 3 or 4), Interrupt therapy until recovery to grade 2 or lower.
Thrombocytopenia: (grade 3:25,000 to less than 50,000/mm(3)), Interrupt therapy until recovery to grade 1 or lower (75,000/mm(3) or greater), and then re-treat with the same dose; (grade 4 (less than 25,000/mm(3)), Interrupt therapy until recovery to grade 1 or lower (75,000/mm(3) or greater) and then reduce the dose by 1 level; first dose reduction to 3 mg/kg every 3 weeks or second dose reduction to 2.4 mg/kg every 3 weeks.
Precaution:
Hepatotoxicity, liver failure, and death have been reported; monitor serum transaminases and bilirubin before treatment initiation. Reduction of left ventricular ejection fraction (LVEF) may occur.
Adverse effect:
Common: constipation, nausea, musculoskeletal pain, headache, fatigue.
Serious: left ventricular cardiac dysfunction, injection site extravasation, anemia, hemorrhage, neutropenia, thrombocytopenia, increased liver enzymes, anaphylactoid reaction, peripheral nerve disease, dyspnea, interstitial lung disease, pneumonitis.