for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
Kadcyla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。（病患應符合下列條件：之前已經接受過轉移性癌症治療，或在輔助療法治療期間或完成治療後6個月內癌症復發。）

Kadcyla (trastuzumab emtansine, T-DM1) is a HER2-antibody drug conjugate which incorporates the HER2 targeted actions of trastuzumab with the microtubule inhibitor DM1 (a maytansine derivative). The conjugate, which is linked via a stable thioether linker, allows for selective delivery into HER2 overexpressing cells, resulting in cell cycle arrest and apoptosis. 

Protein binding: DM1: 93%; Metabolism: DM1 undergoes hepatic metabolism via CYP3A4/5; Elimination Half-life: ~4 days.

Hypersensitivity to trastuzumab emtansine or any component of the formulation. 

D

Excretion in breast milk unknown/not recommended

Nausea (40%), constipation (27%), diarrhea (24%), abdominal pain (19%), vomiting (19%), xerostomia (17%), stomatitis (14%) ; thrombocytopenia (31%), anemia (14%); musculoskeletal pain (36%), peripheral neuropathy (21%; grades 3/4: 2%), arthralgia (19%), weakness (18%), myalgia (14%) ; fatigue (36%), headache (28%), fever (19%), insomnia (12%) ; skin rash (12%); hepatotoxicity.

The recommended dose of Kadcyla is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer Kadcyla at doses greater than 3.6 mg/kg.

For intravenous infusion only! Do not administer as an intravenous push or bolus. Do not use Dextrose (5%) solution. Infuse over 90 minutes (first infusion) or over 30 minutes (subsequent infusions if prior infusions were well tolerated) through a 0.22 micron inline nonprotein adsorptive polyethersulfone filter.

Store intact vials at 2°C to 8°C. Do not freeze or shake intact vials, reconstituted solution, or solutions diluted for infusion.