30 ML eculizumab 10 MG/ML Injection [Soliris]
Dosage & administration
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people also ask
What is the risk of using Soliris during pregnancy?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. However, there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy. 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. 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.
What are the risks associated with PNH and aHUS in pregnancy?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.
What data is available on the use of Soliris during pregnancy?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.
What is the risk of using Soliris during lactation?Although limited published data does not report detectable levels of eculizumab (active ingredient in Soliris) 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.
Is Soliris safe and effective for pediatric patients?Soliris has not been established as safe and effective for the treatment of PNH, gMG, or NMOSD in pediatric patients. However, Soliris has been established as safe and effective for the treatment of aHUS in pediatric patients based on four adequate and well-controlled clinical studies, which included 47 pediatric patients between the ages of 2 months and 17 years. The safety and effectiveness of Soliris for the treatment of aHUS appears similar in pediatric and adult patients.
What vaccines should be administered to pediatric patients receiving Soliris?Pediatric patients receiving Soliris should be administered vaccinations for the prevention of infection due to Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type b (Hib) according to ACIP guidelines.
What is the experience with Soliris in geriatric patients?Fifty-one patients aged 65 years or older were treated with Soliris in clinical trials in the approved indications, including PNH, aHUS, gMG, and NMOSD. 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.
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