Daiichi Sankyo




Daiichi Sankyo
Concise Prescribing Info
Trastuzumab deruxtecan
Monotherapy for the treatment of adult patients w/ unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti-HER2-based regimens.
Dosage/Direction for Use
5.4 mg/kg IV infusion once every 3 wk (21-day cycle) until disease progression or unacceptable toxicity. 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.
Special Precautions
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. Reports of interstitial lung disease (ILD) &/or pneumonitis; neutropenia, including febrile neutropenia; decrease in left ventricular ejection fraction (LVEF). Monitor patients for signs & symptoms of ILD/pneumonitis. Monitor complete blood counts 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. Females of reproductive potential should be advised to use effective contraception during treatment & for at least 7 mth following the last dose of Enhertu. Male patients w/ female partners of reproductive potential should be advised to 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.
Adverse Reactions
Nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anaemia, neutropenia, diarrhoea, thrombocytopenia, cough, leukopenia, headache. Upper resp tract infection; lymphopenia; hypokalaemia; dizziness; dry eye; interstitial lung disease, dyspnoea, epistaxis; abdominal pain, stomatitis, dyspepsia; rash; increased ALT or AST, decreased ejection fraction. Febrile neutropenia; infusion-related reactions.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD04 - trastuzumab deruxtecan ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Enhertu powd for concentrate for soln for infusion 100 mg
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