Soliris(eculizumab)
Dosage & Administration
For intravenous infusion only
Get Your Patient on Soliris
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Soliris Prescribing Information
Soliris Prior Authorization Resources
Most recent state uniform prior authorization forms
Verified: Oct 24, 2024Arizona - Uniform Prior Authorization Form
Verified: Oct 24, 2024Colorado - Uniform Prior Authorization Form
Verified: Oct 24, 2024Hawaii - Uniform Prior Authorization Form
Verified: Oct 24, 2024Illinois - Uniform Prior Authorization Form
Verified: Oct 24, 2024Indiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Louisiana - Uniform Prior Authorization Form
Verified: Oct 24, 2024Minnesota - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Hampshire - Uniform Prior Authorization Form
Verified: Oct 24, 2024New Mexico - Uniform Prior Authorization Form
Verified: Oct 24, 2024Oregon - Uniform Prior Authorization Form
Verified: Oct 24, 2024Texas - Uniform Prior Authorization Form
Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form
Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form
Reimbursement help (FRM)
Soliris Financial Assistance Options
Copay savings program
Learn More
Overview
- Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
- A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
- Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
- Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
- May never be used with government insurance
How to sign up
- Cards may be downloadable digital cards or hard copies
- Some pharmacos offer debit cards with pre-loaded copay benefit
- Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
- Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Soliris PubMed™ News
Soliris Patient Education
To share resource; ask patient to:
1.Pull out phone
2.Open camera
3.Scan QR code with camera
4.Tap link
Patient toolkit
About Soliris: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Resources: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
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Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Patient Brochure (Spanish): AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
Scan QR Code & Tap Link
Doctor Discussion Guide: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link
Open Camera on Phone
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Patient Safety Card: AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (NMOSD)
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Scan QR Code & Tap Link
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Other resources
Soliris FAQs
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.
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.
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.
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.
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.
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.
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.
We receive information directly from the FDA and PrescriberPoint is updated as frequently as change are made available