Kadcyla

Single agent for patients w/ HER2-+ve, unresectable locally advanced or metastatic breast cancer who received prior treatment w/ trastuzumab & a taxane. Single agent for adjuvant treatment of patients w/ HER2-positive early breast cancer who have residual disease, after pre-op systemic treatment that included HER2 targeted therapy.

Recommended dose: 3.6 mg/kg IV infusion every 3 wk (21-day cycle). Administer initial dose as 90-min IV infusion. Subsequent doses may be administered as 30-min infusions. Dose modifications: Starting dose: 3.6 mg/kg. 1st dose reduction: 3 mg/kg. 2nd dose reduction: 2.4 mg/kg. Early breast cancer Duration: 14 cycles. Metastatic breast cancer Duration: Until disease progression or unmanageable toxicity.

Hypersensitivity.

Do not administer as IV push or bolus. Patients must have confirmed HER2-+ve tumor status as assessed by either HER2 protein over-expression or gene amplification. Permanently discontinue use in patients diagnosed w/ ILD, or pneumonitis; ≥Grade 3 or Grade 2 radiation pneumonitis that does not respond to standard treatment; w/ serum transaminases >3x ULN & concomitant total bilirubin >2x ULN; nodular regenerative hyperplasia. Increased risk of pulmonary events in patients w/ dyspnea. Monitor liver function prior to initiation of treatment & each Kadcyla dose. Patients w/ serum transaminases >2.5x ULN or total bilirubin >1.5x ULN; w/ LVEF <50%, & platelet counts <100,000/mm³ prior to initiation of treatment; who had trastuzumab permanently discontinued due to infusion-related reactions. Perform standard cardiac function testing [echocardiogram or multigated acquisition (MUGA) scanning] prior to initiation & at regular intervals (eg, every 3 mth) during treatment. Interrupt treatment in patients w/ severe infusion-related reactions & permanently discontinue in life-threatening infusion-related reaction. Hypersensitivity reactions. Cases of hemorrhagic events. Patients receiving anti-coagulation & antiplatelet therapy, or had thrombocytopenia. Closely monitor patients w/ thrombocytopenia (<100,000/mm³) & on anticoagulant treatment; platelet counts are monitored prior to each dose; possible SC infiltration during administration. Platelet count <100,000/mm³ prior to initial treatment. Do not administer in decreased platelet count to ≥Grade 3 (<50,000/mm³). Temporarily discontinue in patients experiencing Grade 3 or 4 peripheral neuropathy until resolved or improved to ≤Grade 2. Monitor for neurotoxicity. Women of childbearing potential should use effective contraception during & at least 7 mth after treatment. Discontinue breastfeeding prior to initiating treatment & resume breastfeeding 7 mth following last dose of Kadcyla. Do not drive or use machines in patients experiencing infusion-related reaction symptoms. Renal & hepatic impairment. Pregnancy. Childn <18 yr. Elderly ≥75 yr.

Thrombocytopenia, anemia; nausea, constipation, stomatitis, vomiting, dry mouth, diarrhea, abdominal pain; fatigue, pyrexia, asthenia; UTI; increased transaminases; hypokalemia; musculoskeletal pain, arthralgia, myalgia; headache, peripheral neuropathy; insomnia; epistaxis, cough; rash; 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; dizziness, dysgeusia; dyspnea, pneumonitis; pruritus; HTN, hepatic failure, nodular regenerative hyperplasia, portal 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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