Treatment of adult patients w/ HER2 +ve metastatic breast cancer (MBC): as monotherapy for the treatment of patients who have received at least 2 chemotherapy regimens for their metastatic disease (prior chemotherapy must have included at least an anthracycline & a taxane unless patients are unsuitable for these treatments; hormone-receptor +ve patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments); in combination w/ paclitaxel for the treatment of patients who have not received chemotherapy for their metastatic disease & for whom an anthracycline is not suitable; in combination w/ docetaxel for the treatment of patients who have not received chemotherapy for their metastatic disease; in combination w/ an aromatase inhibitor for the treatment of postmenopausal patients w/ hormone-receptor +ve MBC, not previously treated w/ trastuzumab. Treatment of adult patients w/ HER2 +ve early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) & RT (if applicable); following adjuvant chemotherapy w/ doxorubicin & cyclophosphamide, in combination w/ paclitaxel or docetaxel; in combination w/ adjuvant chemotherapy consisting of docetaxel & carboplatin; in combination w/ neoadjuvant chemotherapy followed by adjuvant therapy for locally advanced disease or tumours >2 cm in diameter. In combination w/ capecitabine or 5-fluorouracil & cisplatin for the treatment of adult patients w/ HER2 +ve metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
Dosage/Direction for Use
IV infusion 3-wkly schedule MBC Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Wkly schedule MBC Initial loading dose: 4 mg/kg. Maintenance: 2 mg/kg at wkly intervals, beginning 1 wk after the loading dose. 3-wkly schedule EBC Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Wkly schedule EBC Initial loading dose: 4 mg/kg, followed by 2 mg/kg every wk, concomitantly w/ paclitaxel following chemotherapy w/ doxorubicin & cyclophosphamide. 3-wkly schedule metastatic gastric cancer (MGC) Initial loading dose: 8 mg/kg. Maintenance: 6 mg/kg at 3-wkly intervals, beginning 3 wk after the loading dose. Patients w/ MBC or MGC should be treated until disease progression. Patients w/ EBC should be treated for 1 yr or until disease recurrence, whichever occurs 1st.
Contraindications
Hypersensitivity to trastuzumab, or murine proteins. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary O2 therapy.
Special Precautions
HER2 testing is mandatory prior to therapy initiation. Increased risk for developing CHF (NYHA class II-IV) or asymptomatic cardiac dysfunction, particularly following anthracycline-containing chemotherapy. Exercise caution in treating patients w/ increased cardiac risk eg, HTN, documented CAD, CHF, LVEF of <55%, older age. In the EBC setting, treatment cannot be recommended in patients w/ history of MI, angina pectoris requiring medical treatment, history of or existing CHF (NYHA class II-IV), LVEF of <55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled HTN, & haemodynamic effective pericardial effusion. Patients who receive anthracyclines after stopping Kanjinti may possibly be at increased risk of cardiac dysfunction. Do not give concurrently w/ anthracyclines in the MBC or adjuvant treatment EBC setting. Risk of serious infusion-related reactions (ie, dyspnoea, hypotension, wheezing, HTN, bronchospasm, supraventricular tachyarrhythmia, reduced O2 saturation, anaphylaxis, resp distress, urticaria & angioedema); pre-medication may be used. Risk of severe pulmonary events. Exercise caution for pneumonitis, especially in patients being treated concomitantly w/ taxanes. Minor influence on the ability to drive or use machines. Women of childbearing potential should be advised to use effective contraception during treatment & for 7 mth after treatment has concluded. Avoid during pregnancy unless potential benefit for the mother outweighs potential risk to the foetus. Women should not breast-feed during therapy & for 7 mth after the last dose. Limited clinical experience in patients >65 yr in the neoadjuvant-adjuvant EBC setting.
Sign Out
