USA - engelsk - NLM (National Library of Medicine)

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 12 mg in 1.2 ml - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include relapsing-remitting disease and active secondary progressive disease, in adults. because of its safety profile, the use of lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of ms [see warnings and precautions (5)] . limitations of use lemtrada is not recommended for use in patients with clinically isolated syndrome (cis) because of its safety profile [see warnings and precautions (5)]. lemtrada is contraindicated in patients: - with known hypersensitivity or anaphylactic reactions to alemtuzumab or any of the excipients in lemtrada - who are infected with human immunodeficiency virus (hiv) because lemtrada causes prolonged reductions of cd4+ lymphocyte counts - with active infection risk summary there are no adequate data on the developmental risk associated with the use of lemtrada in pregnant women. lemtrada was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis [see animal data] . auto-antibodies may develop after administration of lemtrada. placental transfer of anti-thyroid antibodies resulting in neonatal graves' disease has been reported. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. there is a pregnancy surveillance program for lemtrada. if lemtrada exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2. clinical considerations lemtrada induces persistent thyroid disorders [see warnings and precautions (5.8)] . untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. in mothers with graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal graves' disease. in a patient who developed graves' disease after treatment with alemtuzumab, placental transfer of anti-thyrotropin receptor antibodies resulted in neonatal graves' disease with thyroid storm in her infant who was born 1 year after alemtuzumab dosing [see warnings and precautions (5.1)] . data animal data when lemtrada was administered to pregnant hucd52 transgenic mice during organogenesis (gestation days [gd] 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, no teratogenic effects were observed. however, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during gd 11–15. in a separate study in pregnant hucd52 transgenic mice, administration of lemtrada during organogenesis (gd 6–10 or gd 11–15) at doses of 3 or 10 mg/kg iv, decreases in b- and t-lymphocyte populations were observed in the offspring at both doses tested. in pregnant hucd52 transgenic mice administered lemtrada at doses of 3 or 10 mg/kg/day iv throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. decreases in t- and b-lymphocyte populations and in antibody response were observed in offspring at both doses tested. risk summary there are no data on the presence of alemtuzumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. alemtuzumab was detected in the milk of lactating hucd52 transgenic mice administered lemtrada [see animal data]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lemtrada and any potential adverse effects on the breastfed child from lemtrada or from the underlying maternal conditions. data animal data alemtuzumab was detected in the milk of lactating hucd52 transgenic mice following intravenous administration of lemtrada at a dose of 10 mg/kg on postpartum days 8–12. serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum day 13 and were associated with evidence of pharmacological activity (decrease in lymphocyte counts) in the offspring. contraception before initiation of lemtrada treatment, women of childbearing potential should be counselled on the potential for a serious risk to the fetus. to avoid in utero exposure to lemtrada, women of childbearing potential should use effective contraceptive measures when receiving a course of treatment with lemtrada and for 4 months following that course of treatment [see use in specific populations (8.1)] . infertility in hucd52 transgenic mice, administration of lemtrada prior to and during the mating period resulted in adverse effects on sperm parameters in males and reduced number of corpora lutea and implantations in females [see nonclinical toxicology (13.1)] . safety and effectiveness in pediatric patients less than 17 years of age have not been established. use of lemtrada is not recommended in pediatric patients due to the risks of autoimmunity, infusion reactions, and stroke, and because it may increase the risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma) [see warnings and precautions (5.1, 5.2, 5.3, 5.4)] . clinical studies of lemtrada did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

USA - engelsk - NLM (National Library of Medicine)

genzyme corporation - alemtuzumab (unii: 3a189dh42v) (alemtuzumab - unii:3a189dh42v) - alemtuzumab 30 mg in 1 ml - campath is indicated as a single agent for the treatment of b-cell chronic lymphocytic leukemia (b-cll). none. risk summary based on findings from animal studies, campath may cause fetal harm when administered to a pregnant woman. available data from published cohort studies in pregnant women are insufficient to establish a campath-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. alemtuzumab was embryolethal in pregnant hucd52 transgenic mice when administered during organogenesis (see data) . human igg antibodies are known to cross the placental barrier; therefore, campath may be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. infants born to pregnant women treated with campath may be at increased risk of infection (see clinical considerations) . the 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

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

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 10 mg/ml - injection, concentrated - excipient ingredients: disodium edetate; potassium chloride; monobasic potassium phosphate; sodium chloride; dibasic sodium phosphate heptahydrate; polysorbate 80; water for injections - lemtrada is indicated for the treatment of relapsing forms of multiple sclerosis (ms) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

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

sanofi-aventis australia pty ltd - alemtuzumab, quantity: 30 mg - injection, intravenous infusion - excipient ingredients: disodium edetate; water for injections; polysorbate 80; monobasic potassium phosphate; dibasic sodium phosphate heptahydrate; sodium chloride; potassium chloride - the treatment of patients with b-cell chronic lymphocytic leukaemia (cll) who have relapsed after failure of two prior therapies.,mabcampath is indicated for the treatment of patients with b-cell chronic lymphocytic leukaemia (b-cll).

Den europeiske union - slovensk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - levkemija, limfocitna, kronična, b-celica - antineoplastična sredstva - zdravilo mabcampath je indicirano za zdravljenje bolnikov s kronično limfocitno levkemijo b (bl), pri katerih kombinirana kemoterapija s fludarabinom ni primerna.

Den europeiske union - latvisk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - leikēmija, limfocītu, hroniska, b-šūna - antineoplastiski līdzekļi - mabcampath ir norādīta pacientiem ar b šūnu hroniskas limfocītu leikēmiju (bcll), kam nav lietderīgi fludarabine kombināciju ķīmijterapiju ārstēšanai.

Den europeiske union - slovakisk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - leukémia, lymfocytárna, chronická, b-bunka - antineoplastické činidlá - mabcampath je indikovaný na liečbu pacientov s b-buniek lymfatickou leukémiou (bcll) pre koho fludarabín kombinácia chemoterapie nie je vhodné.

Den europeiske union - svensk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - leukemi, lymfocytisk, kronisk, b-cell - antineoplastiska medel - mabcampath är indicerat för behandling av patienter med b-cell kronisk lymfatisk leukemi (bcll) för vilka fludarabin kombinationskemoterapi inte är lämpligt.

Den europeiske union - dansk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - leukæmi, lymfocytisk, kronisk, b-celle - antineoplastiske midler - mabcampath er indiceret til behandling af patienter med b-celle kronisk lymfocytisk leukæmi (bcll), for hvem fludarabinkombinationskemoterapi ikke er passende.

Den europeiske union - polsk - EMA (European Medicines Agency)

genzyme europe b.v. - alemtuzumab - białaczka, limfocytowa, przewlekła, komórka b - Środki przeciwnowotworowe - preparat mabcampath jest wskazany w leczeniu pacjentów z przewlekłą białaczką limfocytową z limfocytami b (bcll), u których chemioterapia skojarzona fludarabiny nie jest odpowiednia.