Kadcyla

Trastuzumab emtansine

Monotherapy for adult patients w/ HER2 +ve, unresectable locally advanced or metastatic breast cancer (MBC) who previously received trastuzumab & taxane, separately or in combination, either as prior therapy for locally advanced or metastatic disease, or developed disease recurrence during or w/in 6 mth of completing adjuvant therapy. Adjuvant monotherapy for adult patients w/ HER2 +ve early breast cancer (EBC) who have residual invasive breast &/or lymph nodes disease, after neoadjuvant taxane-based & HER2-targeted therapy.

3.6 mg/kg IV infusion every 3 wk until disease progression or unacceptable toxicity for MBC & total of 14 cycles unless w/ disease recurrence or unmanageable toxicity for EBC. Initial dose: 90 min IV infusion. Subsequent infusions: Over 30 min if prior infusion is well tolerated.

Hypersensitivity.

Not to be administered as IV push or bolus. Hypersensitivity reactions. Assess patients w/ confirmed HER2 +ve tumour status by HER2 protein over-expression or gene amplification. Permanently discontinue treatment if diagnosed w/ ILD or pneumonitis; in the event of life threatening infusion-related reaction. Increased risk of pulmonary events in patients w/ dyspnea at rest due to complications of advanced malignancy, co-morbidities & concurrent pulmonary RT. Nodular regenerative hyperplasia; monitor liver function prior to & during treatment. Temporarily discontinue in patients experiencing Grade 3 or 4 peripheral neuropathy until symptoms resolve or improve to Grade ≤2. Increased risk of developing left ventricular dysfunction. Closely monitor patients w/ thrombocytopenia or receiving anticoagulant & antiplatelet therapy. Hemorrhage. Extravasation. May affect ability to drive & use machines. Severe renal & hepatic impairment. Women of childbearing potential should use effective contraception during & for at least 7 mth after last dose. Not recommended during pregnancy. Discontinue lactation prior to treatment. Childn & adolescents <18 yr. Elderly ≥75 yr.

Thrombocytopenia, anemia; nausea, constipation, stomatitis, vomiting, dry mouth, diarrhea, abdominal pain; fatigue, pyrexia; UTI; increased transaminases; musculoskeletal pain, arthralgia, myalgia; headache, peripheral neuropathy; insomnia; epistaxis, cough; hemorrhage. Neutropenia; left ventricular dysfunction; increased lacrimation, dry eye, blurred vision, conjunctivitis; dyspepsia; chills, peripheral edema; drug hypersensitivity; infusion-related reaction, radiation pneumonitis; increased blood alkaline phosphatase & bilirubin; hypokalemia; dizziness, dysgeusia; dyspnea, pneumonitis; pruritus, rash; HTN.

Potent CYP3A inhibitors.

Targeted Cancer Therapy

L01FD03 - trastuzumab emtansine ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.

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