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DOSING OVERVIEW ULTOMIRIS® provides adult patients with the freedom of predictable, once-every-8-week maintenance dosing starting 2 weeks after an initial loading dose1,2
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    • The ULTOMIRIS dosing regimen offers predictable dosing which allows patients more time between infusions to do what they love
    ULTOMIRIS IV 100 mg/mL infusion1
    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
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    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
    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.
    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
    Concomitant use of ULTOMIRIS with PE, PP, or IVIg treatment can reduce serum ULTOMIRIS concentrations and requires a supplemental dose of ULTOMIRIS.
    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
    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; FcRn, neonatal fragment crystallizable receptor; gMG, generalized myasthenia gravis; IVIg, intravenous immunoglobulin; NaCl, sodium chloride; PE, plasma exchange; PP, plasmapheresis; USP, United States Pharmacopeia.
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    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 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.

    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 generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

    Please see full Prescribing Information for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening or fatal meningococcal infections.
    References:
    1. 1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
    2. 2. Meisel A, et al. J Neurol. 2023;270(8):3862-3875.
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