Dosage & AdministrationDrug labelPrior authorizationFinancial assistance
Patient education

Soliris

(eculizumab)
30 ML eculizumab 10 MG/ML Injection [Soliris]
BLACK BOX WARNING

Dosage & administration

For intravenous infusion only

PNH Dosage Regimen:

aHUS Dosage Regimen:

gMG and NMOSD Dosage Regimen:

Most viewed Soliris resources

Alexion Access Navigator ( All indications)
Letter of Medical Necessity - generalized Myasthenia Gravis ( Anti- AchR+)
Coverage Authorization Appeal - generalized Myasthenia Gravis ( Anti- AchR+)
Letter of Medical Necessity - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
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drug label

Soliris prescribing information

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prior authorization

Soliris Prior authorization resources

NOT PROVIDED BY BRANDComplete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

NOT PROVIDED BY BRANDComplete Coverage Authorization appeals
Alexion Access Navigator ( All indications)
Letter of Medical Necessity - generalized Myasthenia Gravis ( Anti- AchR+)
Coverage Authorization Appeal - generalized Myasthenia Gravis ( Anti- AchR+)
Letter of Medical Necessity - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
Coverage Authorization Appeal - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
Letter of Medical Necessity - atypical Hemolytic Uremic Syndrome

NOT PROVIDED BY BRANDCoverage Authorization Appeal - atypical Hemolytic Uremic Syndrome

NOT PROVIDED BY BRANDCoverage Authorization Appeal - Paroxysmal Nocturnal Hemoglobinuria
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Benefits investigation

NOT PROVIDED BY BRANDBenefits investigation resources
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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information
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financial assistance

Soliris Financial assistance options

Co-pay savings program

commercial only
Enroll in patient savings program
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Bridge program

commercial only
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Foundation programs

under insured
no insurance
goverment insurance
65+
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patient education

Soliris Patient education

Getting started on Soliris

NOT PROVIDED BY BRANDInstructions For Use - generalized Myasthenia Gravis ( Anti- AchR+)

NOT PROVIDED BY BRANDInstructions For Use - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )

NOT PROVIDED BY BRANDInstructions For Use - atypical Hemolytic Uremic Syndrome

NOT PROVIDED BY BRANDInstructions For Use - Paroxysmal Nocturnal Hemoglobinuria

Patient toolkit

About Soliris - generalized Myasthenia Gravis ( Anti- AchR+)
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Patient Resources - generalized Myasthenia Gravis ( Anti- AchR+)
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Patient Stories - generalized Myasthenia Gravis ( Anti- AchR+)
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About Soliris - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
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Patient Resources - Neuromylities Optica Spectrum Disroder ( anti- AQP4 antibody positive )
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About Soliris - atypical Hemolytic Uremic Syndrome
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Patient Stories - atypical Hemolytic Uremic Syndrome
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Open Camera on Phone
Scan QR Code & Tap Link
Patient Resources - atypical Hemolytic Uremic Syndrome
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people also ask

Soliris FAQs

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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