Monotherapy for the treatment of adult patients w/ unresectable or metastatic HER2 +ve breast cancer who have received ≥1 prior anti-HER2-based regimens.
Premed prior to each dose w/ an antiemetic + dexamethasone to counteract delayed nausea &/or vomiting. IV Initially 5.4 mg/kg administered as a 90-min IV infusion once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. If prior infusion is well tolerated, subsequent doses may be administered as 30-min infusions. Dose reduction: 1st dose reduction: 4.4 mg/kg IV infusion, 2nd dose reduction: 3.2 mg/kg IV infusion.
Not to be administered as IV push or bolus. Not to be substituted w/ trastuzumab or trastuzumab emtansine. Not to be mixed or administered w/ other medicinal products through the same IV line. Permanently discontinue in patients who are diagnosed w/ symptomatic (≥Grade 2) ILD/pneumonitis; w/ symptomatic CHF. Cases of ILD/pneumonitis; neutropenia, including febrile neutropenia; decreased LVEF. Consider corticosteroid treatment for asymptomatic ILD/pneumonitis. Promptly initiate corticosteroid treatment (eg, ≥1 mg/kg/day prednisolone or equiv) continue for at least 14 days followed by gradual taper for at least 4 wk. Monitor CBC prior to treatment initiation & each dose. Perform cardiac function testing [echocardiogram or MUGA (multigated acquisition) scanning] prior treatment initiation & at regular intervals during treatment. May affect ability to drive & use machines. Moderate or severe hepatic impairment. May cause foetal harm when administered to pregnant woman. Verify pregnancy status of women of childbearing potential prior to initiation. Women of childbearing potential should use effective contraception during treatment & for at least 7 mth following the last dose. Men w/ female partners of childbearing potential should use effective contraception during treatment & for at least 4 mth after the last dose. Not recommended to pregnant women. Women should not breastfeed during treatment or for 7 mth after the last dose. Childn & adolescents <18 yr. Elderly ≥75 yr.
L01FD04 - trastuzumab deruxtecan ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
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