Skip to main content

Dosing Overview

Images are not of actual patients

ULTOMIRIS® provides adult patients with the freedom of predictable, once-every-8-week maintenance dosing starting 2 weeks after an initial loading dose1,2

Dosing Regimen

The ULTOMIRIS dosing regimen offers predictable dosing which allows patients more time between infusions to do what they love

ULTOMIRIS IV 100 mg/mL infusion with weight-based dosing. ULTOMIRIS dosing schedule includes a once-every-8-week maintenance dosing starting 2 weeks after an initial loading dose.

6-7 maintenance infusions per year1

Each infusion typically lasts less than 1 hour for the majority of patients.1,a
  • Patients are monitored for at least 1 hour after infusions for signs or symptoms of an infusion-related reaction1
  • If an adverse reaction occurs during the administration of ULTOMIRIS (ravulizumab-cwvz), the infusion may be slowed or stopped at the discretion of the physician1
  • The recommended weight-based dosing regimen in adult patients with generalized myasthenia gravis (gMG) (≥40 kg [88 lb]) consists of a loading dose followed 2 weeks later by the start of maintenance dosing every 8 weeks1
  • The dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but subsequent doses should be administered according to the original schedule1
  • Following a missed intravenous ULTOMIRIS dose, the patient should contact their healthcare provider immediately1

aMinimum infusion time for ULTOMIRIS 100 mg/mL maintenance doses ranges from 30 minutes to less than 1 hour, depending on body weight.1

WATCH: gMG expert discusses ULTOMIRIS dosing

Watch Deena Rodney, APRN, provide a deep dive on the predictable ULTOMIRIS dosing regimen and administration.

Download: Dosing and Administration Guide

Infusion Locator

Looking for an infusion location for your patient?

Jesse, a patient living with gMG.
Jesse has received compensation from Alexion Pharmaceuticals, Inc.
Find an Infusion
Location

If you would like to be added to the list of infusion locations, email us at: UltomirisInfusionLocator@astrazeneca.com. In your email, please provide: Name of Practice, Street Address, City, State, ZIP Code, Phone Number, and Website URL (optional).

Infusion locator tool
Jesse, a patient living with gMG.
Jesse has received compensation from Alexion Pharmaceuticals, Inc.

Doses and infusion times for ULTOMIRIS 100 mg/mL1

dose adjustments possible with ULTOMIRIS by body weight range

bBody weight at time of treatment.1

cApproximate weight in pounds was calculated using standard weight conversion of 1 kg=2.205 lb.

If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Monitor the patient for at least 1 hour following completion of the infusion for signs or symptoms of an infusion-related reaction.1

ULTOMIRIS Dosing Calculator

This calculator tool is for reference only. See the full dosing chart above and the recommended weight-based dosing regimen for gMG in section 2.6 of the ULTOMIRIS Prescribing Information.

Units

Loading dose (mg)

Maintenance dose (mg)

100 mg/mL formulation loading dose vials

100 mg/mL formulation maintenance dose vials

Weight-based dosing

The recommended dosage of ULTOMIRIS in adult patients with gMG weighing 40 kg or greater is based on the patient’s body weight.1

IV line flushing

The IV infusion set tubing should be flushed at the end of the infusion to help ensure the full dose of ULTOMIRIS is administered. This is important for all patients, especially due to the weight-based dosing and small volume (<100 mL) of ULTOMIRIS 100 mg/mL.1

ULTOMIRIS 100 mg/mL dosing at a glance1

Body Weight
Ranged		 ULTOMIRIS Volume Volume of 0.9% of NaCle Total Volume (dose) Minimum Infusion Timef Maximum Infusion Rate
ULTOMIRIS Vial
Combinations
1100 mg/
11 ml 300 mg/
3 ml
Loading Dose Administration
 40 kg (88 lb)
to <60 kg
(132 lb)		 24 mL + 24 mL= 48 mL (2400 mg) 48 min 60 mL /hr — 8
60 kg (132 lb)
to <100 kg
(220 lb)		 27 mL+ 27 mL = 54 mL (2700 mg) 36 min 90 mL /hr — 9
100 kg (220 lb)
or greater		 30 mL+ 30 mL = 60 mL (3000 mg) 24 min 150 mL/hr — 10
Maintenance Dose Administration
 40 kg (88 lb)
to <60 kg
(132 lb)		 30 mL+ 30 mL = 60 mL (3000 mg) 54 min 67 mL/hr — 10
60 kg (132 lb)
to <100 kg
(220 lb)		 33 mL+ 33 mL = 66 mL (3300 mg) 42 min 95 mL/hr 3 —
100 kg (220 lb)
or greater		 36 mL+ 36 mL = 72 mL (3600 mg) 30 min 144 mL/hr 3 1
Ultomiris 100 mg/mL at a glance

dBody weight at time of treatment.1

eDilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.1

fMinimum infusion time for ULTOMIRIS 100 mg/mL maintenance doses ranges from 30 minutes to less than 1 hour, depending on body weight.1

Supplemental dosing of ULTOMIRIS after PE, PP, or IVIg1

Concomitant use of ULTOMIRIS with PE, PP, or IVIg treatment can reduce serum ULTOMIRIS concentrations and requires a supplemental dose of ULTOMIRIS.

ULTOMIRIS supplemental dosing after PP, PE, or IVIg by body weight range

gBody weight at time of treatment.1

Neonatal Fc receptor (FcRn) blockers

Concomitant use of ULTOMIRIS with FcRn blockers (eg, efgartigimod) may lower systemic exposures and reduce the effectiveness of ULTOMIRIS. Closely monitor for reduced effectiveness.1

8 weeks

With a predictable infusion schedule, ULTOMIRIS increases freedom between doses for adult patients with gMG who are anti-AChR antibody positive. ULTOMIRIS offers the only once-every-8-week maintenance dosing schedule starting 2 weeks after an initial dose1

AChR, acetylcholine receptor; gMG, generalized myasthenia gravis; IVIg, intravenous immunoglobulin; NaCl, sodium chloride; PE, plasma exchange; PP, plasmapheresis; USP, United States Pharmacopeia.

Mike, a patient living with gMG.
Mike has received compensation from Alexion Pharmaceuticals, Inc. and has a relative who works for Alexion.

Learn more about ULTOMIRIS and the available personalized support

Explore Support Resources

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

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)].

SUPPORT

Connect with Alexion

Connect with a live ULTOMIRIS representative by calling 1-833-445-2111, emailing gMGSupport@astrazeneca.com, or via our online form

Support

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 gMG (incidence ≥10%) were diarrhea and upper respiratory tract infection. Serious adverse reactions were reported in 20 (23%) of patients treated with ULTOMIRIS and in 14 (16%) patients receiving placebo. The most frequent serious adverse reactions were infections reported in at least 8 (9%) patients treated with ULTOMIRIS and in 4 (4%) patients treated with placebo. Of these infections, one fatal case of COVID-19 pneumonia was identified in a patient treated with ULTOMIRIS and one case of infection led to discontinuation of 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.

INDICATION
ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

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.

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

References:

References:

  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  1. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  2. Vu T, et al. NEJM Evid. 2022;1(5):1-22.
  3. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  4. Data on file. Alexion Pharmaceuticals, Inc.
  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  3. Draft article 2.
  1. Data on file. Alexion Pharmaceuticals, Inc.
  2. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  1. ULTOMIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  2. Data on file. Alexion Pharmaceuticals, Inc.
  3. Muppidi S, et al; MG Composite and MG-QOL15 Study Group. Muscle Nerve. 2011;44(5):727-731.
  4. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  5. Vu T, et al. NEJM Evid. 2022;1(5):1-22.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Kulasekararaj AG, et al. Blood. 2019;133(6):540-549.
  3. Lee JW, et al. Blood. 2019;133(6):530-539.
  4. Vu T, et al. J Neurol. 2023;270(6):3129-3137.
  5. Kusner LL, et al. Ann N Y Acad Sci. 2012;1274(1):127-132.
  6. Meriggioli MN, et al. Lancet Neurol. 2009;8(5):475-490.
  7. Conti-Fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  8. Howard JF Jr. Ann N Y Acad Sci. 2018;1412(1):113-128.
  9. Engel AG, et al. Mayo Clin Proc. 1977;52(5):267-280.
  10. Sahashi K, et al. J Neuropathol Exp Neurol. 1980;39(2):160-172.
  11. Murphy K, et al. Janeway's Immunobiology. 9th ed. Garland Science, Taylor & Francis Group, LLC; 2017:37-76.
  12. Rother RP, et al. Nat Biotechnol. 2007;25(11):1256-1264.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. 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.
  3. 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.
  4. 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.
  5. SOLIRIS. Prescribing Information. Alexion Pharmaceuticals, Inc.
  6. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Mbaeyi SA, et al; Advisory Committee on Immunization Practices. Centers for Disease Control and Prevention; 2020. Accessed February 8, 2024. https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htm
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  3. Vu T, et al. NEJM Evid. 2022;1(5):1-12.
  4. Data on file. Alexion Pharmaceuticals, Inc.
  5. Howard JF Jr, et al. Poster presented at: 14th Myasthenia Gravis Foundation of America International Conference; May 10-12, 2022; Miami, FL.
  6. Habib AA, et al. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Myasthenia Gravis Foundation of America Scientific Session; September 21, 2022; Nashville, TN.
  7. Vu T, et al. J Neurol. 2023;(270):3129-3137.
  8. Jaretzki A III, et al. Neurology. 2000;55(1):16-23.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Data on file. Alexion Pharmaceuticals, Inc.
  3. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Conti-Fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Conti-fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  1. Conti-Fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  2. Howard JF Jr. Ann N Y Acad Sci. 2018;1412(1):113-128.
  3. Mantegazza R, et al. Immunotargets Ther. 2020;9:317-331.
  4. Anil R, et al. J Neurol Sci. 2020;414:116830.
  5. Tomschik M, et al. Neurology. 2020;95:10.e1426-e1436.
  6. Oh S. J Clin Neurol. 2009;5:53-64.
  7. Hendricks TM, et al. Am J Ophthalmol. 2019;205:99-105.
  8. Mercelis R, et al. Acta Neurol Belg. 2023;123:375-384.
  9. Guptil JT, et al. Neurotherapeutics. 2016;13(1):118-131.
  10. Li Y, et al. Cleve Clin J Med. 2013;80(11):711-721.
  11. Meriggioli MN, et al. Lancet Neurol. 2009;8(5):475-490.
  12. Engel AG, et al. Mayo Clin Proc. 1977;52(5):267-280.
  13. Sahashi K, et al. J Neuropathol Exp Neurol. 1980;39(2):160-172.
  14. Data on file. Alexion Pharmaceuticals, Inc.
  15. Vincent A, et al. UK Myasthenia Gravis Survey. J Neurol Neurosurg Psychiatry. 2003;74(8):1105-1108.
  16. Law, N., et al. Neurol Ther. 2021;10(1):1103-1125.
  17. Muppidi S, et al. Muscle Nerve. 2011;44(5):727-731.
  18. Myasthenia Gravis Foundation of America. Accessed April 1, 2024. https://myasthenia.org/portals/0/qmg.pdf
  19. Jaretzki A, et al. Ann Thorac Surg. 2000;70(1):327-334.
  20. Sharshar T, et al. JAMA Neurol. 2021;78(4):426-433.
  21. Sanders DB, et al. Neurology. 2016;87(4):419-425.
  22. Melzer J, et al. J Neurol. 2016;263:1473-1494.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. 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):0195909.
  3. 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.
  4. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  5. Vu T, et al. NEJM Evid. 2022;1(5).
  6. Meisel A, et al; CHAMPION MG Study Group. J Neurol. 2023;270(8):3862-3875.
  7. Muppidi S, et al; MG Composite and MG-QOL15 Study Group. Muscle Nerve. 2011;44(5);727-731.
  8. Howard JF Jr. Ann N Y Acad Sci. 2018;1412(1):113-128.
  9. Kusner LL, et al. Ann N Y Acad Sci. 2012;1274(1):127-132.
  10. Meriggioli MN, et al. Lancet Neurol. 2009;8(5):475-490.
  11. Conti-Fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  12. Data on file. Alexion Pharmaceuticals, Inc.