As a single agent for treatment of patients w/ HER2 +ve, metastatic breast cancer (MBC) who previously received trastuzumab & taxane, separately or in combination; patients should have either received prior therapy for metastatic disease or developed disease recurrence during or w/in 6 mth of completing adjuvant therapy. As a single agent for adjuvant treatment of patients w/ HER2 +ve early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane & trastuzumab-based treatment.
Recommended dose: 3.6 mg/kg IV infusion every 3 wk (21-day cycle). 1st infusion: Over 90 min, observe patient during infusion & for at least 90 min following initial dose for fever, chills, or other infusion-related reactions (IRRs). Subsequent infusions: Over 30 min if prior infusions were well tolerated. Observe patient during & for at least 30 min after infusion. MBC Patient should receive treatment until disease progression or unmanageable toxicity. EBC Patient should receive treatment for a total of 14 cycles unless there is disease recurrence or unmanageable toxicity.
View Kadcyla overdosage for action to be taken in the event of an overdose.
Special Precautions
Do not administer as IV push or bolus. Assess HER2 protein overexpression &/or HER2 gene amplification. Do not substitute for or w/ trastuzumab. Do not administer at doses >3.6 mg/kg. Do not mix or administer as an infusion w/ other medicinal products. Monitor serum transaminases & bilirubin prior to initiation & at each dose; reduce dose or discontinue in case of increased serum transaminases &/or total bilirubin; permanently discontinue in patients w/ serum transaminases >3 x ULN & concomitant total bilirubin >2 x ULN, & upon diagnosis of nodular regenerative hyperplasia. Increased risk of developing left ventricular dysfunction; assess LVEF prior to initiation & at regular intervals during treatment. Permanently discontinue if diagnosed w/ ILD or pneumonitis; in patients w/ Grade ≥3 or 2 radiation pneumonitis not responding to standard treatment in the adjuvant setting. Increased risk of pulmonary toxicity in patients w/ dyspnea at rest. Not recommended in patients permanently discontinued from trastuzumab treatment due to IRRs &/or hypersensitivity; interrupt in patients w/ severe IRR; permanently discontinue in the event of a life-threatening IRR. Closely monitor IRRs especially during 1st infusion. Cases of hemorrhagic events including CNS, resp & GI hemorrhage. Reports of thrombocytopenia & decreased platelet count; monitor platelet counts prior to initiation & at each dose. In the event of decreased platelet count to ≥Grade 3, w/hold treatment until platelet count recovers to Grade 1. Closely monitor patients w/ thrombocytopenia or those on anticoagulants during treatment. Peripheral neuropathy has been reported; temporarily discontinue in Grade 3 or 4 until resolution to ≤Grade 2. Closely monitor infusion site for possible SC infiltration. Severe hepatic impairment. Advise females w/ reproductive potential to use effective contraception during treatment & for 7 mth following the last dose. Can cause fetal harm when administered to a pregnant woman; monitor for oligohydramnios. Do not breastfeed during treatment & for 7 mth following the last dose. Ped patients.
Sign Out
