Abbreviated Prescribing Information
Enhertu

Presentation: Enhertu powder for concentrate for solution for infusion 100 mg. Active ingredient: Trastuzumab deruxtecan. Indications: Breast cancer: As monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. As monotherapy indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Gastric cancer: As monotherapy indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Dosage: 5.4 mg/kg for breast cancer, 6.4mg/kg for gastric cancer, given as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Precautions: Patients should be monitored for signs and symptoms of ILD/pneumonitis; neutropenia; left ventricular ejection fraction decrease; embryo-foetal toxicity to a pregnant woman; moderate and severe hepatic impairment. Undesirable effects: Upper respiratory tract infection, pneumonia, anaemia, neutropenia, thrombocytopenia, leukopenia, lymphopenia, decreased appetite, hypokalaemia, headache, dizziness, dysgeusia, interstitial lung disease, cough, dyspnoea, epistaxis, nausea, vomiting, diarrhoea, constipation, abdominal pain, stomatitis, dyspepsia, transaminases increased, alopecia, rash, musculoskeletal pain, fatigue, pyrexia, oedema peripheral, weight decreased, ejection fraction decreased, febrile neutropenia, dehydration, vision blurred, abdominal distension, flatulence, gastritis, pruritus, skin hyperpigmentation, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased, infusion-related reactions. Frequencies of undesirable effects vary with dosage, for further detail, please refer to full prescribing information.
Full local prescribing information is available upon request.
API.HK.ENH.0323

HK-11031 28/10/2024