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

mylan institutional llc - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - ogivri is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)]. ogivri is indicated: select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)]. ogivri is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with her2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)] . none.   trastuzumab products can cause fetal harm when administered to a pregnant woman. in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see data) . apprise the patient of the potential risks to a fetus. there are clinical considerations if a trastuzumab product is used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of a trastuzumab product (see clinical considerations) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. monitor women who received ogivri 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. in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities and neonatal death. these case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy. in some case reports, amniotic fluid index increased after trastuzumab was stopped. in one case, trastuzumab therapy resumed after amniotic index improved, and oligohydramnios recurred. in studies where trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (gestation days 20 to 50) and late (gestation days 120 to 150) phases of gestation. the resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects. there is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production. published data suggest human igg is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. trastuzumab was present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity (see data) . consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ogivri treatment and any potential adverse effects on the breastfed child from ogivri or from the underlying maternal condition. this consideration should also take into account the trastuzumab product wash out period of 7 months [see clinical pharmacology (12.3)] . in lactating cynomolgus monkeys, trastuzumab was present in breast milk at about 0.3% of maternal serum concentrations after pre-(beginning gestation day 120) and post-partum (through post-partum day 28) doses of 25 mg/kg administered twice weekly (25 times the recommended weekly human dose of 2 mg/kg of trastuzumab products). infant monkeys with detectable serum levels of trastuzumab did not exhibit any adverse effects on growth or development from birth to 1 month of age. verify the pregnancy status of females of reproductive potential prior to the initiation of ogivri. trastuzumab products can cause embryo-fetal harm when administered during pregnancy. advise females of reproductive potential to use effective contraception during treatment with ogivri and for 7 months following the last dose of ogivri [see use in specific populations (8.1) and clinical pharmacology (12.3)] . the safety and effectiveness of trastuzumab products in pediatric patients have not been established. trastuzumab has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). the risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in studies 5 and 6, or adjuvant therapy in studies 1 and 2. limitations in data collection and differences in study design of the 4 studies of trastuzumab in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of trastuzumab in older patients is different from younger patients. the reported clinical experience is not adequate to determine whether the efficacy improvements (orr, ttp, os, dfs) of trastuzumab treatment in older patients is different from that observed in patients < 65 years of age for metastatic disease and adjuvant treatment. in study 7 (metastatic gastric cancer), of the 294 patients treated with trastuzumab, 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. no overall differences in safety or effectiveness were observed.

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

biocon biologics inc. - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - ogivri is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)]. ogivri is indicated: select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)]. ogivri is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with her2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)] . none.   trastuzumab products can cause fetal harm when administered to a pregnant woman. in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death (see data) . apprise the patient of the potential risks to a fetus. there are clinical considerations if a trastuzumab product is used in a pregnant woman or if a patient becomes pregnant within 7 months following the last dose of a trastuzumab product (see clinical considerations) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. monitor women who received ogivri 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. in post-marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities and neonatal death. these case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy. in some case reports, amniotic fluid index increased after trastuzumab was stopped. in one case, trastuzumab therapy resumed after amniotic index improved, and oligohydramnios recurred. in studies where trastuzumab was administered to pregnant cynomolgus monkeys during the period of organogenesis at doses up to 25 mg/kg given twice weekly (up to 25 times the recommended weekly human dose of 2 mg/kg), trastuzumab crossed the placental barrier during the early (gestation days 20 to 50) and late (gestation days 120 to 150) phases of gestation. the resulting concentrations of trastuzumab in fetal serum and amniotic fluid were approximately 33% and 25%, respectively, of those present in the maternal serum but were not associated with adverse developmental effects. there is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production. published data suggest human igg is present in human milk but does not enter the neonatal and infant circulation in substantial amounts. trastuzumab was present in the milk of lactating cynomolgus monkeys but not associated with neonatal toxicity (see data) . consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for ogivri treatment and any potential adverse effects on the breastfed child from ogivri or from the underlying maternal condition. this consideration should also take into account the trastuzumab product wash out period of 7 months [see clinical pharmacology (12.3)] . in lactating cynomolgus monkeys, trastuzumab was present in breast milk at about 0.3% of maternal serum concentrations after pre-(beginning gestation day 120) and post-partum (through post-partum day 28) doses of 25 mg/kg administered twice weekly (25 times the recommended weekly human dose of 2 mg/kg of trastuzumab products). infant monkeys with detectable serum levels of trastuzumab did not exhibit any adverse effects on growth or development from birth to 1 month of age. verify the pregnancy status of females of reproductive potential prior to the initiation of ogivri. trastuzumab products can cause embryo-fetal harm when administered during pregnancy. advise females of reproductive potential to use effective contraception during treatment with ogivri and for 7 months following the last dose of ogivri [see use in specific populations (8.1) and clinical pharmacology (12.3)] . the safety and effectiveness of trastuzumab products in pediatric patients have not been established. trastuzumab has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings). the risk of cardiac dysfunction was increased in geriatric patients as compared to younger patients in both those receiving treatment for metastatic disease in studies 5 and 6, or adjuvant therapy in studies 1 and 2. limitations in data collection and differences in study design of the 4 studies of trastuzumab in adjuvant treatment of breast cancer preclude a determination of whether the toxicity profile of trastuzumab in older patients is different from younger patients. the reported clinical experience is not adequate to determine whether the efficacy improvements (orr, ttp, os, dfs) of trastuzumab treatment in older patients is different from that observed in patients < 65 years of age for metastatic disease and adjuvant treatment. in study 7 (metastatic gastric cancer), of the 294 patients treated with trastuzumab, 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. no overall differences in safety or effectiveness were observed.

European Union - English - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - breast neoplasms - antineoplastic agents - breast cancerher2-positive breast cancerenhertu as monotherapy is 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.her2-low breast cancerenhertu as monotherapy is 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 (see section 4.2).non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.gastric cancerenhertu as monotherapy is 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. 

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)

pfizer laboratories div pfizer inc - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - trazimera is indicated for adjuvant treatment of her2-overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline based therapy. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)] . trazimera is indicated: - in combination with paclitaxel for first-line treatment of her2-overexpressing metastatic breast cancer - as a single agent for treatment of her2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)]. trazimera is

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

cephalon, inc. - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - herzuma is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline based therapy. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)] . herzuma is indicated: - in combination with paclitaxel for first-line treatment of her2-overexpressing metastatic breast cancer - as a single agent for treatment of her2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for a trastuzumab product [see dosage and administration (2.1)] . herzuma is indi

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

genentech, inc. - trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck) - trastuzumab 440 mg in 20 ml - herceptin is indicated for adjuvant treatment of her2 overexpressing node positive or node negative (er/pr negative or with one high risk feature [see clinical studies (14.1)] ) breast cancer - as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel - as part of a treatment regimen with docetaxel and carboplatin - as a single agent following multi-modality anthracycline based therapy. select patients for therapy based on an fda-approved companion diagnostic for herceptin [see dosage and administration (2.1)] . herceptin is indicated: - in combination with paclitaxel for first-line treatment of her2-overexpressing metastatic breast cancer - as a single agent for treatment of her2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. select patients for therapy based on an fda-approved companion diagnostic for herceptin [see dosage and administration (2.1)] . herceptin is indicated, in combinat

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 - 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