Concise Prescribing Info
Trastuzumab emtansine
Metastatic breast cancer (mBC): As a single agent for treatment of patients w/ HER2-positive, unresectable locally advanced or metastatic breast cancer who received prior treatment w/ trastuzumab & a taxane. Early breast cancer (eBC): As a single agent for the adjuvant treatment of patients w/ HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane & trastuzumab-based treatment.
Dosage/Direction for Use
3.6 mg/kg IV infusion every 3 wk (21-day cycle). Administer initial dose as a 90-min 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. For a total of 14 cycles unless there is disease recurrence or unmanageable toxicity in eBC, & until disease progression or unmanageable toxicity for mBC. If a planned dose is missed, administer as soon as possible; do not wait until next planned cycle.
Special Precautions
Patients treated w/ Kadcyla must have confirmed HER2-positive tumor status as assessed by either HER2 protein over-expression or gene amplification. Increased risk of pulmonary events in patients w/ dyspnea. Permanently discontinue use in patients diagnosed w/ interstitial lung disease, or pneumonitis, patients w/ serum transaminases >3 x ULN & concomitant total bilirubin >2 x ULN, in cases of nodular regenerative hyperplasia. Monitor liver function prior to initiation of therapy & each Kadcyla dose. Increased risk of developing left ventricular dysfunction. Perform standard cardiac function testing prior to initiation & at regular intervals (eg, every 3 mth) during treatment. Patients w/ LVEF <50% prior to initial therapy. Interrupt treatment in patients w/ severe infusion-related reactions & permanently discontinue in life-threatening infusion-related reaction. Hypersensitivity reactions eg, serious anaphylactic reactions. Cases of hemorrhagic events. Closely monitor patients w/ thrombocytopenia & on anticoagulant treatment. Monitor platelet counts prior to each dose. Do not administer in decreased platelet count to ≥Grade 3 (<50,000/mm3). Neurotoxicity. Temporarily discontinue in patients experiencing Grade 3 or 4 peripheral neuropathy until resolved or improved to ≤Grade 2. Closely monitor infusion site for possible subcutaneous infiltration during drug administration. Patients experiencing symptoms of infusion related reactions should be advised not to drive & use machines until symptoms abate. Women of childbearing potential should use effective contraception during & at least 7 mth after treatment. Discontinue lactation prior to initial treatment & may begin 7 mth after concluding treatment. Hepatic impairment. Pregnancy. Childn <18 yr.
Adverse Reactions
On early breast cancer & metastatic breast cancer: Thrombocytopenia, anemia; nausea, constipation, vomiting, diarrhea, dry mouth, abdominal pain, stomatitis; fatigue, pyrexia, asthenia, chills; UTI; increased transaminases; hypokalemia; musculoskeletal pain, arthralgia, myalgia; headache, peripheral neuropathy; insomnia; epistaxis, cough, dyspnea; rash; hemorrhage.
Drug Interactions
Co-administration w/ potent CYP3A inhibitors.
ATC Classification
L01XC14 - trastuzumab emtansine ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Kadcyla powd for infusion 160 mg
20 mL x 1's
Kadcyla powd for infusion 100 mg
15 mL x 1's
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