chlorek chlormekwatu - search results

European Union - English - EMA (European Medicines Agency)

oncaspar

les laboratoires servier - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

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

valchlor- mechlorethamine hydrochloride gel

actelion pharmaceuticals us, inc. - mechlorethamine (unii: 50d9xsg0vr) (mechlorethamine - unii:50d9xsg0vr) - mechlorethamine 0.012 g in 60 g - valchlor is an alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy. the use of valchlor is contraindicated in patients with known severe hypersensitivity to mechlorethamine. hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. pregnancy category d [see warnings and precautions (5.5) ] risk summary mechlorethamine can cause fetal harm when administered to a pregnant woman. there are case reports of children born with malformations in pregnant women systemically administered mechlorethamine. mechlorethamine was teratogenic in animals after a single subcutaneous administration. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see warnings and precautions (5.5) ]. animal data mechlorethamine caused fetal malformat

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

mustargen mechlorethamine hydrochloride powder for solution

recordati rare diseases, inc. - mechlorethamine hydrochloride (unii: l0mr697hhi) (mechlorethamine - unii:50d9xsg0vr) - mechlorethamine hydrochloride 10 mg in 10 ml

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

valchlor- mechlorethamine hydrochloride gel

helsinn therapeutics (u.s.), inc. - mechlorethamine (unii: 50d9xsg0vr) (mechlorethamine - unii:50d9xsg0vr) - valchlor is indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous t-cell lymphoma in patients who have received prior skin-directed therapy. the use of valchlor is contraindicated in patients with known severe hypersensitivity to mechlorethamine. hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine. risk summary based on case reports in humans, findings in animal reproduction studies, its mechanism of action, and genotoxicity findings, mechlorethamine may cause fetal harm. available published case reports in pregnant women receiving intravenous mechlorethamine demonstrate that mechlorethamine can cause major birth defects when a pregnant woman is systemically exposed. in animal reproduction studies, subcutaneous administration of mechlorethamine to pregnant rats and ferrets during organogenesis resulted in embryo‐fetal mortality, alterations to growth, and structural abnormalities. based on limited available data with valchlor use in pregnant women, if valchlor is used during pregnancy or if the patient becomes pregnant while taking this drug, patient should be advised of the potential risk to the fetus. 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 2-4% and 15-20%, respectively. data human data the limited available data with valchlor use in pregnant women does not show evidence of congenital malformation in newborns. cases of newborns with congenital malformations have been reported in women who received systemic mechlorethamine during pregnancy. animal data mechlorethamine caused fetal malformations in the rat and ferret when given as single subcutaneous injections of 1 mg/kg. other findings in animals included embryo lethality and growth retardation when administered as a single subcutaneous injection. risk summary there are no data on the presence of mechlorethamine or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. because of the potential for topical or systemic exposure to valchlor through exposure to the mother's skin and the potential for serious adverse reactions in the breastfed child from mechlorethamine, advise patients not to breastfeed during treatment with valchlor. contraception females advise female patients of reproductive potential to use effective contraception during treatment with valchlor. a barrier method of contraception should be used to avoid direct exposure of reproductive organs to valchlor. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with valchlor [ see nonclinical toxicology (13.1) ]. a barrier method of contraception should be used to avoid direct exposure of reproductive organs to valchlor. infertility based on animal data, mechlorethamine may impair fertility in males and females [see nonclinical toxicology (13.1) ]. the reversibility of the effect on fertility is unknown. safety and effectiveness in pediatric patients have not been established. a total of 79 patients age 65 and older (31% of the clinical trial population) were treated with either valchlor or the comparator in the clinical trial. forty-four percent (44%) of patients age 65 or older treated with valchlor achieved a cails response compared to 66% of patients below the age of 65. seventy percent (70%) of patients age 65 and older experienced cutaneous adverse reactions and 38% discontinued treatment due to adverse reactions, compared to 58% and 14% in patients below the age of 65, respectively. similar differences in discontinuation rates between age subgroups were observed in the comparator group.