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

alexion pharmaceuticals inc. - eculizumab (unii: a3ulp0f556) (eculizumab - unii:a3ulp0f556) - eculizumab 300 mg in 30 ml - soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (pnh) to reduce hemolysis. soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (ahus) to inhibit complement-mediated thrombotic microangiopathy. limitation of use soliris is not indicated for the treatment of patients with shiga toxin e. coli related hemolytic uremic syndrome (stec-hus). soliris is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. soliris is contraindicated for initiation in patients with unresolved serious neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary limited data on outcomes of pregnancies that have occurred following soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) in pregnancy (see clinical considerations ). animal studies using a mouse analogue of the soliris molecule (murine anti-c5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see data ). the estimated background risk of major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. ahus in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (iugr), fetal death and low birth weight. data human data a pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to soliris have not suggested safety concerns. however, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. animal data animal reproduction studies were conducted in mice using doses of a murine anti-c5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human soliris dose, based on a body weight comparison. when animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. when maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. when maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). surviving offspring had normal development and reproductive function. risk summary although limited published data does not report detectable levels of eculizumab in human milk, maternal igg is known to be present in human milk. available information is insufficient to inform the effect of eculizumab on the breastfed infant. there are no data on the effects of eculizumab on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. safety and effectiveness of soliris for the treatment of pnh, gmg, or nmosd in pediatric patients have not been established. the safety and effectiveness of soliris for the treatment of ahus have been established in pediatric patients. use of soliris in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of soliris for the treatment of ahus. the studies included a total of 47 pediatric patients (ages 2 months to 17 years). the safety and effectiveness of soliris for the treatment of ahus appear similar in pediatric and adult patients [see adverse reactions (6.1), and clinical studies (14.2) ]. administer vaccinations for the prevention of infection due to neisseria meningitidis , streptococcus pneumoniae and haemophilus influenzae type b (hib) according to acip guidelines [see warnings and precautions (5.1, 5.3)] . fifty-one patients 65 years of age or older (15 with pnh, 4 with ahus, 26 with gmg, and 6 with nmosd) were treated with soliris in clinical trials in the approved indications. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

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

food and drug administration - eculizumab (unii: a3ulp0f556) (eculizumab - unii:a3ulp0f556) -

Israel - English - Ministry of Health

alexion pharma israel ltd - eculizumab - concentrate for solution for infusion - eculizumab 10 mg/ml - eculizumab - eculizumab - soliris is indicated for the treatment of patients with: - paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. eculizumab has not been studied in clinical trials in patients with pnh below 11 years of age.- atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of: - refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive.-neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease who have received prior therapy.

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

alexion pharmaceuticals australasia pty ltd - eculizumab, quantity: 300 mg - injection, intravenous infusion - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - soliris is indicated for the treatment of patients with: ? paroxysmal nocturnal haemoglobinuria (pnh) to reduce haemolysis. ? atypical haemolytic uraemic syndrome (ahus). ? adult patients with neuromyelitis optica spectrum disorder (nmosd) who are anti-aquaporin-4 (aqp4) antibody-positive. soliris is not intended for acute treatment of a nmosd relapse.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - eculizumab 300mg;  ;  ;   - solution for infusion - 300mg/30ml - active: eculizumab 300mg       excipient: dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 80 sodium chloride water for injection - soliris® is indicated for the treatment of patients with paroxysmal nocturnal haemoglobinuria (pnh)to reduce haemolysis.

European Union - English - EMA (European Medicines Agency)

amgen technology (ireland) uc - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1).

European Union - English - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinuria, paroxysmal - immunosuppressants - soliris is indicated in adults and children for the treatment of:paroxysmal nocturnal haemoglobinuria (pnh).evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history (see section 5.1). atypical haemolytic uremic syndrome (ahus).soliris is indicated in adults for the treatment of:refractory generalized myasthenia gravis (gmg) in patients who are anti-acetylcholine receptor (achr) antibody-positive (see section 5.1).neuromyelitis optica spectrum disorder (nmosd) in patients who are anti-aquaporin-4 (aqp4) antibody-positive with a relapsing course of the disease.

Canada - English - Health Canada

alexion pharma gmbh - eculizumab - solution - 10mg - eculizumab 10mg - complement inhibitors

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - eculizumab - infusion, solution concentrate - 300 mg / vial - eculizumab 300 mg / vial

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alexion pharma uk ltd - eculizumab - solution for infusion - 10mg/1ml