Skip to main content

Resources

Discover tools and resources for your practice and your patients

Filter by category:

​

Showing: All Resources

Healthcare Professional Resources

ultomiris patient subscriber start form thumbnail

Patient & Prescriber Start Form

Get your patients started on ULTOMIRIS® and enrolled in OneSource™ with this one form.

Download Patient & Prescriber Start Form
OneSource®: Personalized Patient Support from Alexion

OneSource

OneSource is a personalized complimentary patient support program that can help navigate insurance, answer questions about ULTOMIRIS, and more.

Get Started With OneSource
ultomiris hcp starter kit thumbnail New Patient Checklist ultomiris patient subscriber start form thumbnail Alexion REMS QR Form

HCP Starter Kit

A selection of resources designed to help you and your practice start your patients on ULTOMIRIS.

Download Full HCP Starter Kit

Dosing & Administration Guide

Step-by-step instructions for initiating ULTOMIRIS weight-based dosing.

Download Dosing & Administration Guide

Vaccination Guide

Overview of vaccination requirements for ULTOMIRIS.

Download Vaccination Guide

Initiation Guide

Overview of topics when commencing treatment for NMOSD.

Download Initiation Guide

Patient Resources

Vaccination Card

As part of the REMS program, this card highlights the risk of meningococcal infection for NMOSD patients taking ULTOMIRIS.

Download Vaccination Card

Patient Brochure

Information about ULTOMIRIS, including how it works and what can be expected when starting treatment.

Download Patient Brochure

REMS Patient Safety Card

Guidance on the risk of meningococcal infection for NMOSD patients taking ULTOMIRIS and provider information, should adverse events occur.

Download REMS Patient Safety Card

Access Resources

ultomiris sample letter of medical necessity thumbnail

Sample Letter of Medical Necessity

This is a sample letter that may be used to communicate why treatment with ULTOMIRIS is medically necessary.

Download Sample Letter of Medical Necessity

Field Reimbursement Managers

Alexion Field Reimbursement Managers (FRMs) provide education and support to healthcare professional offices to facilitate patient access to their prescribed Alexion medications.

Download Field Reimbursement Managers

ULTOMIRIS Access & Reimbursement Guide

An access and reimbursement educational support resource for healthcare professionals, healthcare professional offices, and infusion centers that administer ULTOMIRIS.

Download ULTOMIRIS Access & Reimbursement Guide

ULTOMIRIS NMOSD Common Prior Authorization Criteria

Presents the common criteria that may be requested by payers for prior authorization of ULTOMIRIS in NMOSD as well as general information about the prior authorization processes.

Download ULTOMIRIS NMOSD Common Prior Authorization Criteria

Compendium of NMOSD References for ULTOMIRIS

An overview of references for ULTOMIRIS in NMOSD that is inclusive of the Prescribing Information, FDA approval letter, and other public domain evidence.

Download Compendium of NMOSD References for ULTOMIRIS

Peer-to-Peer Medical Review

Resource that provides education and support for healthcare professionals, healthcare professional offices, and infusion centers about using a peer-to-peer review as a potential next step before submitting a formal appeal.

Download Peer-to-Peer Medical Review

ULTOMIRIS NMOSD Sample Appeal Letter

This templated sample letter provides support to healthcare providers in the appeals process in the event the patient’s health insurance plan denies coverage for ULTOMIRIS in NMOSD.

Download ULTOMIRIS NMOSD Sample Appeal Letter

ULTOMIRIS NMOSD Coding & Billing Guide

The ULTOMIRIS NMOSD Coding & Billing Guide contains objective and factual coding, billing, and claims information to support access and appropriate reimbursement for ULTOMIRIS in NMOSD.

Download ULTOMIRIS NMOSD Coding & Billing Guide

Access Considerations for Home Infusion of Intravenous Therapies

Resource that provides education for healthcare professionals and healthcare professional offices on home infusion access and reimbursement.

Download Access Considerations for Home Infusion of Intravenous Therapies

Reauthorization Guide

Resource that provides education and support for healthcare professionals, healthcare professional offices, and infusion centers about the reauthorization process, including health plan requirements and timing implications for reauthorizations.

Download Reauthorization Guide

Videos

Watch Video on ULTOMIRIS Mechanism of Action
Video Thumbnail
13:51

ULTOMIRIS Mechanism of Action Video

Watch how ULTOMIRIS inhibits the complement protein C5.1

​

NMOSD, neuromyelitis optica spectrum disorder; REMS, Risk Evaluation and Mitigation Strategy.

Request a rep and learn more about ULTOMIRIS

Get in Touch

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

Alexion Connect

Healthcare professionals:
Answers to your questions are
a phone call away! Connect
with a live representative.
1-833-445-2111

Get Support

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)] Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
  • Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS [see Warnings and Precautions (5.2)].

CONTRAINDICATIONS

  • Initiation in patients with unresolved serious Neisseria meningitidis infection.

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

ULTOMIRIS, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.

Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ULTOMIRIS. The benefits and risks of treatment with ULTOMIRIS, as well as those associated with antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.

Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if they occur. Promptly treat known infections. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection depending on the risks of interrupting treatment in the disease being treated.

ULTOMIRIS and SOLIRIS REMS

Due to the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.

Prescribers must enroll in the REMS, counsel patients about the risk of serious meningococcal infection, provide patients with the REMS educational materials, assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ULTOMIRIS. Antibacterial drug prophylaxis must be prescribed if treatment must be started urgently, and the patient is not up to date with both meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of ULTOMIRIS. Patients must receive counseling about the need to receive meningococcal vaccines and to take antibiotics as directed, signs and symptoms of meningococcal infection, and be instructed to carry the Patient Safety Card at all times during and for 8 months following ULTOMIRIS treatment.

Further information is available at www.UltSolREMS.com or 1-888-765-4747.

Other Infections

Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Patients receiving ULTOMIRIS are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Thromboembolic Event Management

The effect of withdrawal of anticoagulant therapy during treatment with ULTOMIRIS has not been established. Treatment should not alter anticoagulant management.

Infusion-Related Reactions

Administration of ULTOMIRIS may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1 to 7% of patients, including lower back pain, abdominal pain, muscle spasms, drop or elevation in blood pressure, rigors, limb discomfort, drug hypersensitivity (allergic reaction), and dysgeusia (bad taste). These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS and institute appropriate supportive measures.

ADVERSE REACTIONS

Most common adverse reactions in adult patients with NMOSD (incidence ≥10%) were COVID-19, headache, back pain, arthralgia, and urinary tract infection. Serious adverse reactions were reported in 8 (13.8%) patients with NMOSD receiving ULTOMIRIS.

DRUG INTERACTIONS

Plasma Exchange, Plasmapheresis, and Intravenous Immunoglobulins

Concomitant use of ULTOMIRIS with plasma exchange (PE), plasmapheresis (PP), or intravenous immunoglobulin (IVIg) treatment can reduce serum ravulizumab concentrations and requires a supplemental dose of ULTOMIRIS.

Neonatal Fc Receptor Blockers

Concomitant use of ULTOMIRIS with neonatal Fc receptor (FcRn) blockers (e.g., efgartigimod) may lower systemic exposures and reduce effectiveness of ULTOMIRIS. Closely monitor for reduced effectiveness of ULTOMIRIS.

USE IN SPECIFIC POPULATIONS
 Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ULTOMIRIS during pregnancy. Healthcare providers and patients may call 1-833-793-0563 or go to www.UltomirisPregnancyStudy.com to enroll in or to obtain information about the registry.

To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION

ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

Please see full Prescribing Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening or fatal meningococcal infections.

References:

  1. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  2. Yenerel MN, Sicre de Fontbrune F, Piatek C, et al. Phase 3 study of subcutaneous versus intravenous ravulizumab in eculizumab-experienced adult patients with PNH: primary analysis and 1-year follow-up. Adv Ther. 2023;40(1):211-232.
  3. Fam S, Parks B, Allen K, et al. Meningococcal infections in eculizumab- or ravulizumab-treated patients: a clinical and real-world pharmacovigilance update across indications, including neuromyelitis optica spectrum disorder. Poster presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 18-20, 2024, Copenhagen, Denmark.
  1. Wingerchuk DM, Zhang I, Kielhorn A, et al. Network meta-analysis of Food and Drug Administration-approved treatment options for adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder. Neurol Ther. 2022;11(1):123-135.
  2. Piatek P, Domowicz M, Lewkowicz N, et al. C5a-preactivated neutrophils are critical for autoimmune-induced astrocyte dysregulation in neuromyelitis optica spectrum disorder. Front Immunol. 2018;9:1694.
  3. Mealy MA, Kessler RA, Rimler Z, et al. Mortality in neuromyelitis optica is strongly associated with African ancestry. Neurol Neuroimmunol Neuroinflamm. 2018;5(4):e468.
  4. Jarius S, Ruprecht K, Wildemann B, et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. J Neuroinflammation. 2012;9:14.
  5. Kitley J, Leite MI, Nakashima I, et al. Prognostic factors and disease course in aquaporin-4 antibody-positive patients with neuromyelitis optica spectrum disorder from the United Kingdom and Japan. Brain. 2012;135(pt 6):1834-1849.
  6. Jiao Y, Fryer JP, Lennon VA, et al. Updated estimate of AQP4-IgG serostatus and disability outcome in neuromyelitis optica. Neurology. 2013;81(14):1197-1204.
  7. Kessler RA, Mealy MA, Levy M. Treatment of neuromyelitis optica spectrum disorder: acute, preventive, and symptomatic. Curr Treat Options Neurol. 2016;18(1):2.
  8. Borisow N, Mori M, Kuwabara S, Scheel M, Paul F. Diagnosis and treatment of NMO spectrum disorder and MOG-encephalomyelitis. Front Neurol. 2018;9:888.
  9. Hamid SHM, Whittam D, Mutch K, et al. What proportion of AQP4-IgG-negative NMO spectrum disorder patients are MOG-IgG positive? A cross sectional study of 132 patients. J Neurol. 2017;264(10):2088-2094.
  10. Chamberlain JL, Huda S, Whittam DH, Matiello M, Morgan BP, Jacob A. Role of complement and potential of complement inhibitors in myasthenia gravis and neuromyelitis optica spectrum disorders: a brief review. J Neurol. 2021;268(5):1643-1664.
  11. Winkler A, Wrzos C, Haberl M, et al. Blood-brain barrier resealing in neuromyelitis optica occurs independently of astrocyte regeneration. J Clin Invest. 2021;131(5):e141694.
  12. Kawachi I, Lassmann H. Neurodegeneration in multiple sclerosis and neuromyelitis optica. J Neurol Neurosurg Psychiatry. 2017;88(2):137-145.
  13. Kümpfel T, Giglhuber K, Aktas O, et al. Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) – revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part II: attack therapy and long-term management. J Neurol. 2024;271(1):141-176.
  14. Capobianco M, Ringelstein M, Welsh C, et al. Characterization of disease severity and stability in NMOSD: a global clinical record review with patient interviews. Neurol Ther. 2023;12:635-650.
  15. Papadopoulos MC, Verkman AS. Aquaporin water channels in the nervous system. Nat Rev Neurosci. 2013;14(4):265-277.
  16. Papadopoulos MC, Verkman AS. Aquaporin 4 and neuromyelitis optica. Lancet Neurol. 2012;11(6):535-544.
  17. Kowarik MC, Astling D, Gasperi C, et al. CNS aquaporin-4-specific B cells connect with multiple B-cell compartments in neuromyelitis optica spectrum disorder. Ann Clin Transl Neurol. 2017;4(6):369-380.
  18. Wingerchuk DM. Neuromyelitis optica spectrum disorders: critical role of complement-dependent cytotoxicity. Neurol Rev. 2017;3(suppl):S1-S4.
  19. Weinshenker BG, Wingerchuk DM. Neuromyelitis spectrum disorders. Mayo Clin Proc. 2017;92(4):663-679.
  20. Papadopoulos MC, Bennett JL, Verkman AS. Treatment of neuromyelitis optica: state-of-the-art and emerging therapies. Nat Rev Neurol. 2014;10(9):493-506.
  1. Ortiz S, Pittock SJ, Berthele A, et al. Immediate and sustained terminal complement inhibition with ravulizumab in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. Front Neurol. 2024;15:1332890.
  2. Piatek P, Domowicz M, Lewkowicz N, et al. C5a-preactivated neutrophils are critical for autoimmune-induced astrocyte dysregulation in neuromyelitis optica spectrum disorder. Front Immunol. 2018;9:1694:1-16.
  3. Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1053-1068.
  4. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  5. Papadopoulos MC, Bennett JL, Verkman AS. Treatment of neuromyelitis optica: state-of-the-art and emerging therapies. Nat Rev Neurol. 2014;10(9):493-506.
  6. Papadopoulos MC, Verkman AS. Aquaporin water channels in the nervous system. Nat Rev Neurosci. 2013;14(4):265-277.
  7. Murphy K, Weaver C, eds. Janeway’s Immunobiology. 9th ed. Garland Science, Taylor & Francis Group LLC; 2017:37-76.
  8. Jarius S, Ruprecht K, Wildemann B, et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: a multicentre study of 175 patients. J Neuroinflammation. 2012;9:14.
  9. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25(11):1256-1264.
  10. Data on file. Alexion Pharmaceuticals, Inc.
  1. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  2. Data on file. Alexion Pharmaceuticals, Inc.
  1. Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1053-1068.
  2. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  3. Data on file. Alexion Pharmaceuticals, Inc.
  4. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  5. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625.
  6. Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.
  7. Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(5):402-412.
  8. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363.
  9. Flanagan EP, Levy M, Katz E, et al. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022;57:103352.
  10. Wingerchuk DM, Fujihara K, Palace J, et al. Long-term safety and efficacy of eculizumab in aquaporin-4 IgG-positive NMOSD. Ann Neurol. 2021;89(6):1088-1098.
  1. Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1053-1068.
  2. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  3. Pittock SJ, et al. Efficacy and safety of ravulizumab in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: interim analysis from the ongoing phase 3 CHAMPION-NMOSD trial. Poster presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, February 29-March 2, 2024, West Palm Beach, FL.
  4. Data on file. Alexion Pharmaceuticals, Inc.
  5. National Multiple Sclerosis Society. Ambulation index (Al). Accessed January 17, 2024. https://www.nationalmssociety.org/for-professionals/for-researchers/researcher-resources/research-tools/clinical-study-measures/ai
  6. National Institutes of Health. Expanded Disability Status Scale (EDSS). Updated April 2020. https://www.commondataelements.ninds.nih.gov/report-viewer/23802/Expanded%20Disability%20Status%20Scale%20(EDSS)
  7. National Institutes of Health. Hauser Ambulation Index (AI). Updated March 2018. https://commondataelements.ninds.nih.gov/report-viewer/23838/Hauser%20Ambulation%20Index%20(AI)
  8. Hauser SL, Dawson DM, Lehrich JR, et al. Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med. 1983;308(4):173-180.
  9. Berthele A, Barnett M, Parks B, et al. Ravulizumab treatment in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: hospitalization outcomes from the phase 3 CHAMPION-NMOSD trial. Poster presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, February 29-March 2, 2024, West Palm Beach, FL.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1093-168.
  3. Data on file. Alexion Pharmaceuticals, Inc.
  4. Pittock SJ, et al. Efficacy and safety of ravulizumab in adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder: interim analysis from the ongoing phase 3 CHAMPION-NMOSD trial. Poster presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024, February 29-March 2, 2024, West Palm Beach, FL.
  1. Pittock SJ, Barnett M, Bennett JL, et al. Ravulizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Ann Neurol. 2023;93(6):1053-1068.
  2. Pittock SJ, Berthele A, Fujihara K, et al. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(7):614-625.
  3. Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114-2124.
  4. Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomized, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(5):402-412.
  5. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): A double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019;394(10206):1352-1363.
  6. Flanagan EP, Levy M, Katz E, et al. Inebilizumab for treatment of neuromyelitis optica spectrum disorder in patients with prior rituximab use from the N-MOmentum Study. Mult Scler Relat Disord. 2022;57:103352.
  7. Wingerchuk DM, Fujihara K, Palace J, et al. Long-term safety and efficacy of eculizumab in aquaporin-4 IgG-positive NMOSD. Ann Neurol. 2021;89(6):1088-1098.
  8. Levy M, Parks B, Allen K, et al. Safety findings in patients with AQP4+ NMOSD who received eculizumab or ravulizumab in the PREVENT and CHAMPION-NMOSD studies and had received rituximab within 1 year prior to enrolment. Poster presented at the 9th Joint ECTRIMS-ACTRIMS Meeting (MSMilan2023). October 11-13, 2023. Milan, Italy.
  9. Kümpfel T, Giglhuber K, Aktas O, et al. Update on the diagnosis and treatment of neuromyelitis optica spectrum disorders (NMOSD) - revised recommendations of the Neuromyelitis Optica Study Group (NEMOS). Part II: attack therapy and long term management. J Neurol. 2024;271(1):141-176.
  10. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  1. Sheridan D, Yu Z-X, Zhang Y, et al. Design and preclinical characterization of ALXN1210: A novel anti-C5 antibody with extended duration of action. PLoS One. 2018;13(4): e0195909.
  2. Röth A, Rottinghaus ST, Hill A, et al. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018;2(17): 2176-2185.
  3. Rother R, Rollins S, Mojcik C, et al. Erratum: Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Nat Biotechnol. 2007;25:1488.
  4. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  5. SOLIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Centers for Disease Control and Prevention. Clinical guidance for managing meningococcal disease risk in patients receiving complement inhibitor therapy. Meningococcal disease. Updated November 26, 2024. Accessed January 30, 2025. https://www.cdc.gov/meningococcal/hcp/clinical-guidance/complement-inhibitor.html
  3. Centers for Disease Control and Prevention. Adult immunization schedule by age. Vaccines & Immunizations. Published November 21, 2024. Accessed January 30, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html
  4. Centers for Disease Control and Prevention. Adult immunization schedule notes. Updated November 21, 2024. Accessed January 30, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html#note-mining
  5. Centers for Disease Control and Prevention. Clinical guidance for meningococcal disease. Updated August 21, 2024. Accessed January 30, 2025. https://www.cdc.gov/meningococcal/hcp/clinical-guidance/index.html
  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. IBM Micromedex. Redbook. 2024. Accessed January 7, 2024. https://www.micromedexsolutions.com
  3. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  4. SOLIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.