United States - English - 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 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 gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen. 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 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 unresectable or metastatic her2-mutant 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 locally advanced or metastatic her2-positive 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. 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)].

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

afaxys pharma, llc - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - norgestimate 0.250 mg - vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . vylibra is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see  warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabet

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

rpk pharmaceuticals, inc. - norgestimate (unii: c291hfx4dy) (norgestimate - unii:c291hfx4dy), ethinyl estradiol (unii: 423d2t571u) (ethinyl estradiol - unii:423d2t571u) - vylibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see clinical studies (14)] . vylibra is contraindicated in females who are known to have or develop the following conditions: - a high risk of arterial or venous thrombotic diseases. examples include women who are known to: smoke, if over age 35 [see boxed warning and warnings and precautions (5.1)] have deep vein thrombosis or pulmonary embolism, now or in the past [see warnings and precautions (5.1)] have inherited or acquired hypercoagulopathies [see warnings and precautions (5.1)] have cerebrovascular disease [see warnings and precautions (5.1)] have coronary artery disease [see  warnings and precautions (5.1)] have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see warnings and precautions (5.1)] have uncontrolled hypertension [see warnings and precautions (5.4)] have diabet

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

omegapharm - mitomycin, quantity: 20 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

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

omegapharm - mitomycin, quantity: 10 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

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

omegapharm - mitomycin, quantity: 2 mg - injection, powder for - excipient ingredients: mannitol - mitomycin is indicated in the palliative treatment of carcinoma of the stomach, pancreas, colon, lung (non-small cell), breast, cervix, head and neck, liver and bladder.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ego pharmaceutical proprietary limited - melaleuca oil - liquid - melaleuca oil oil-plant extract active 50.0 mg/g - household insecticide - pest control - personal use - fly | mosquito | sand fly (biting midge) | adult mosquitoes

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ego pharmaceutical proprietary limited - melaleuca oil - liquid - melaleuca oil oil-plant extract active 50.0 mg/g - household insecticide - pest control - personal use - fly | mosquito | sand fly (biting midge) | adult mosquitoes

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - atenolol - tablets - atenolol 100 mg - atenolol - atenolol - management of angina pectoris and hypertension,including hypertension of renal origin. late intervention after acute myocardial infarction.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - triamcinolone - tablets - triamcinolone 4 mg - triamcinolone - triamcinolone - rheumatology: - active phases of systemic vasculitis: panarteritis nodosa (in patients with concomitant positive hepatitis b serology, the duration of treatment should be restricted to two weeks), polymyalgia rheumatica (pmr), pmr with giant cell arteritis, arteritis temporalis with acute visual loss;- active phases of systemic rheumatic disease: systemic lupus erythematosus, mixed connective tissue disease;- severe progressive forms of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations;- other forms of inflammatory rheumatic arthritis, provided that the severity of symptoms requires it and non-steroidal anti-inflammatory drugs (nsaids) cannot be used:spondylarthritis (ankylosing spondylitis with involvement of peripheral joints, psoriatic arthritis, enteropathic arthropathy with high inflammatory activity);- reactive forms of arthritis;- arthritis in sarcoidosis;- severe systemic form of juvenile idiopathic arthritis (still’s disease) or with iridocyclitis refractory to topical treatment.pulmonary and respiratory tract disorders: - bronchial asthma:for the long-term treatment of severe chronic asthma (category 4) and for treatment of exacerbations in adults and children.- chronic obstructive pulmonary disease (copd):for short-term treatment (max. 14 days) of exacerbations;- upper respiratory tract disorders:for short-term treatment of severe forms of allergic rhinitis in adults after failure of all other treatment alternatives, including topical glucocorticoids.dermatology: - oral initial treatment of extensive, severe, acute skin conditions responsive to glucocorticoids, such as: allergic skin disease (e.g. acute urticaria, contact dermatitis, drug eruption), atopic eczema (acute exacerbations or extensive weeping eczema), pemphigus vulgaris.nephrology: - minimal change glomerulonephritis;- extracapillary proliferative glomerulonephritis (rapidly progressive glomerulonephritis), generally in combination with cytostatics, tapering and ending treatment in goodpasture’s syndrome; for all other forms, long-term continuation of treatment;- idiopathic retroperitoneal fibrosis.