Monotherapy for the treatment of adult patients w/ unresectable or metastatic HER2 +ve breast cancer who have received ≥1 prior anti-HER2-based regimens. Monotherapy for the treatment of adult patients w/ unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or w/in 6 mth of completing adjuvant chemotherapy. Monotherapy for the treatment of adult patients w/ advanced HER2 +ve gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Initial dose should be administered as a 90-min IV infusion. If prior infusion was well tolerated, subsequent doses may be administered as 30-min infusions. Breast cancer 5.4 mg/kg IV infusion once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. Gastric cancer 6.4 mg/kg IV infusion once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity.
Do not administer as IV push or bolus. Do not substitute w/ trastuzumab or trastuzumab emtansine. Slow infusion rate or interrupt if patient develops infusion-related symptoms; permanently discontinue in case of severe infusion reactions. Emetogenic. Reports of ILD &/or pneumonitis; neutropenia, including febrile neutropenia; decrease in left ventricular ejection fraction (LVEF). Monitor patients for signs & symptoms of ILD/pneumonitis. Monitor CBC prior to treatment initiation, prior to each dose, & as clinically indicated. Perform standard cardiac function testing to assess LVEF prior to initiation & at regular intervals during treatment as clinically indicated. Minor influence on the ability to drive & use machines. Patients w/ moderate to severe hepatic or renal impairment. Can cause foetal harm when administered to pregnant woman. May impair male reproductive function & fertility. 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 in pregnant women. Women should not breast-feed during treatment or for 7 mth after the last dose. Safety & efficacy have not been established in childn & adolescents <18 yr. Limited data available in patients ≥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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