Israel - Englisch - 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."

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

daiichi sankyo inc. - trastuzumab deruxtecan (unii: 5384hk7574) (trastuzumab deruxtecan - unii:5384hk7574) - enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-positive (ihc 3+ or ish positive) breast cancer who have received a prior anti-her2-based regimen either: - in the metastatic setting, or - in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-low (ihc 1+ or ihc 2+/ish-) breast cancer, as determined by an fda-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy [see dosage and administration (2.1)] . enhertu is indicated for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (nsclc) whose tumors have activating her2 (erbb2) mutations, as detected by an fda-approved test, and who have received a prior systemic therapy. this indication is approved under accelerated approval based on objective response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. enhertu is indicated for the treatment of adult patients with locally advanced or metastatic her2-positive (ihc 3+ or ihc 2+/ish positive) gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen. enhertu is indicated for the treatment of adult patients with unresectable or metastatic her2-positive (ihc 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. this indication is approved under accelerated approval based on objective response rate and duration of response [see clinical studies (14.5)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. none. risk summary based on its mechanism of action, enhertu can cause fetal harm when administered to a pregnant woman. there are no available data on the use of enhertu in pregnant women. in postmarketing reports, use of a her2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see data ). based on its mechanism of action, the topoisomerase inhibitor component of enhertu, dxd, can also cause embryo-fetal harm when administered to a pregnant woman because it is genotoxic and targets actively dividing cells [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] . advise patients of the potential risks to a fetus. there are clinical considerations if enhertu is used in pregnant women, or if a patient becomes pregnant within 7 months after the last dose of enhertu (see clinical considerations ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions monitor women who received enhertu during pregnancy or within 7 months prior to conception for oligohydramnios. if oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care. data human data there are no available data on the use of enhertu in pregnant women. in postmarketing reports in pregnant women receiving a her2-directed antibody, cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported. these case reports described oligohydramnios in pregnant women who received a her2-directed antibody either alone or in combination with chemotherapy. in some case reports, amniotic fluid index increased after use of a her2-directed antibody was stopped. animal data there were no animal reproductive or developmental toxicity studies conducted with fam-trastuzumab deruxtecan-nxki. risk summary there is no data regarding the presence of fam-trastuzumab deruxtecan-nxki in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with enhertu and for 7 months after the last dose. pregnancy testing verify pregnancy status of females of reproductive potential prior to initiation of enhertu. contraception females enhertu can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with enhertu and for 7 months after the last dose. males because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with enhertu and for 4 months after the last dose [see nonclinical toxicology (13.1)] . infertility based on findings in animal toxicity studies, enhertu may impair male reproductive function and fertility [see nonclinical toxicology (13.1)] . safety and effectiveness of enhertu have not been established in pediatric patients. of the 1287 patients with her2-positive or her2-low breast cancer treated with enhertu 5.4 mg/kg, 22% were 65 years or older and 3.8% were 75 years or older. no overall differences in efficacy within clinical studies were observed between patients ≥65 years of age compared to younger patients. there was a higher incidence of grade 3-4 adverse reactions observed in patients aged 65 years or older (59%) as compared to younger patients (49%)., of the 101 patients with her2-mutant unresectable or metastatic nsclc treated with enhertu 5.4 mg/kg, 40% were 65 years or older and 8% were 75 years or older. no overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. of the 125 patients with her2-positive locally advanced or metastatic gastric or gej adenocarcinoma treated with enhertu 6.4 mg/kg in destiny-gastric01, 56% were 65 years or older and 14% were 75 years or older. no overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. of the 192 patients with her2-positive (ihc 3+) unresectable or metastatic solid tumors treated with enhertu 5.4 mg/kg in destiny-pantumor02, destiny-lung01 or destiny-crc02, 39% were 65 years or older and 9% were 75 years or older. no overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients. no dose adjustment of enhertu is required in patients with mild (creatinine clearance [clcr] ≥60 and <90 ml/min) or moderate (clcr ≥30 and <60 ml/min) renal impairment [see clinical pharmacology (12.3)] . a higher incidence of grade 1 and 2 ild/pneumonitis has been observed in patients with moderate renal impairment [see warnings and precautions (5.1)]. monitor patients with moderate renal impairment more frequently. the recommended dosage of enhertu has not been established for patients with severe renal impairment (clcr <30 ml/min) [see clinical pharmacology (12.3)]. no dose adjustment of enhertu is required in patients with mild (total bilirubin ≤uln and any ast >uln or total bilirubin >1 to 1.5 times uln and any ast) or moderate (total bilirubin >1.5 to 3 times uln and any ast) hepatic impairment. in patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor, dxd [see dosage and administration (2.3)]. the recommended dosage of enhertu has not been established for patients with severe hepatic impairment (total bilirubin >3 times uln and any ast) [see clinical pharmacology (12.3)].

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - trastuzumab(genetical recombination)[trastuzumab biosimilar 3] - injection

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

pfizer pharmaceuticals inc. - trastuzumab(genetical recombination)[trastuzumab biosimilar 3] - injection

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

celltrion healthcare japan k.k - trastuzumab(genetical recombination) [trastuzumab biosimilar 1] - injection

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - trastuzumab(genetical recombination) [trastuzumab biosimilar 1] - injection

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

celltrion healthcare japan k.k - trastuzumab(genetical recombination) [trastuzumab biosimilar 1] - injection

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - trastuzumab(genetical recombination) [trastuzumab biosimilar 1] - injection

Europäische Union - Englisch - 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.

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab, quantity: 60 mg - injection, powder for - excipient ingredients: histidine hydrochloride monohydrate; polysorbate 20; trehalose dihydrate; histidine - early breast cancer. herceptin is indicated for the treatment of patients with her2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. locally advanced breast cancer.herceptin is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin. metastatic breast cancer. herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2: a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease, b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer. advanced gastric cancer. herceptin is indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.