Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 171 mg - injection, powder for - excipient ingredients: sodium hydroxide; sucrose; polysorbate 20; succinic acid - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 106 mg - injection, powder for - excipient ingredients: sucrose; polysorbate 20; succinic acid; sodium hydroxide - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

United States - English - NLM (National Library of Medicine)

genentech, inc. - trastuzumab emtansine (unii: se2kh7t06f) (ado-trastuzumab emtansine - unii:se2kh7t06f) - ado-trastuzumab emtansine 20 mg in 1 ml - kadcyla® , as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: - received prior therapy for metastatic disease, or - developed disease recurrence during or within six months of completing adjuvant therapy. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. none. pregnancy pharmacovigilance program there is a pregnancy pharmacovigilance program for kadcyla. if kadcyla is administered during pregnancy, or if a patient becomes pregnant while r

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab emtansine - powder for concentrate for solution for infusion - trastuzumab emtansine 20 mg/ml - trastuzumab - "early breast cancer (ebc):kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab -based treatment."metastatic breast cancer (mbc)kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:• received prior therapy for metastatic disease, or• developed disease recurrence during or within six months of completing adjuvant therapy."

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - trastuzumab emtansine - breast neoplasms - antineoplastic agents - early breast cancer (ebc)kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with her2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and her2-targeted therapy.metastatic breast cancer (mbc)kadcyla, as a single agent, is indicated for the treatment of adult patients with her2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:received prior therapy for locally advanced or metastatic disease, ordeveloped disease recurrence during or within six months of completing adjuvant therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg) - powder for infusion - 100 mg - active: trastuzumab emtansine 100mg (plus 6% vial overfill = trastuzumab emtansine 106mg) excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - kadcyla as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included her2-targeted therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) - powder for infusion - 160 mg - active: trastuzumab emtansine 160mg (plus 7% vial overfill = trastuzumab emtansine 171mg) excipient: polysorbate 20 sodium hydroxide succinic acid sucrose - kadcyla as a single agent, is indicated for the treatment of patients with her2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either: received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual disease after pre-operative systemic treatment that included her2-targeted therapy.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - trastuzumab - solution for infusion - trastuzumab 440 mg/ml - trastuzumab - trastuzumab - herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: 1. as a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. in combination with paclitaxel or docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. early breast cancer (ebc) :herceptin is indicated to treat patients with her2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. herceptin should only be used in patients whose tumors have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.her2 metastatic gastric cancer (mgc)herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.herceptin should only be used in patients with metastatic gastric cancer whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory fish+ result, or ihc 3+, as determined by an accurate and validated assay

Canada - English - Health Canada

hoffmann-la roche limited - trastuzumab emtansine - powder for solution - 100mg - trastuzumab emtansine 100mg - antineoplastic agents

Canada - English - Health Canada

hoffmann-la roche limited - trastuzumab emtansine - powder for solution - 160mg - trastuzumab emtansine 160mg - antineoplastic agents