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Frequently Asked Questions

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Find answers to Frequently Asked Questions

Here are some answers to common questions that providers and other healthcare professionals treating adults living with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) may have about ULTOMIRIS® (ravulizumab-cwvz).

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Treatment

Who is ULTOMIRIS indicated for?

ULTOMIRIS is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.1

Learn more about gMG

How does ULTOMIRIS make a difference in patients’ lives?

ULTOMIRIS is proven to deliver improvement in activities of daily living. Based on Myasthenia Gravis Activities of Daily Living (MG-ADL) total score, ULTOMIRIS demonstrated efficacy vs placebo at Week 26 (-3.1 vs -1.4, respectively [P=0.0009]). Mean (SD) MG-ADL total scores at baseline: Placebo (n=89) 8.9 (2.3), and ULTOMIRIS (n=86) 9.1 (2.6).1-3

Explore more efficacy data

What is the ULTOMIRIS mechanism of action?

In gMG, a part of the immune system called complement disrupts signals between the muscles and nerves. Normally, the complement system helps the body fight off infections but in gMG, the complement cascade causes damage at the NMJ. ULTOMIRIS inhibits the complement protein C5—a key driver of damage to the NMJ in gMG.1,4 The precise mechanism by which ULTOMIRIS exerts its therapeutic effect in gMG patients is not known.1,4-7

Review the ULTOMIRIS Mechanism of Action

How is ULTOMIRIS administered?

ULTOMIRIS provides adult patients with predictable, once-every-8-week maintenance dosing, starting 2 weeks after initial loading dose1:

  • 1 maintenance infusion every 8 weeks; 6-7 maintenance infusions per year after a loading dose
  • 1 hour or less for the majority of patients. Patients are monitored for at least 1 hour after infusions for signs or symptoms of an infusion-related reaction. If an adverse reaction occurs during the intravenous administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician

Learn more about the ULTOMIRIS dosing regimen

Safety

What are the side effects of ULTOMIRIS?

The most common side effects reported in ≥10% of people taking ULTOMIRIS were diarrhea and upper respiratory tract infection.1

Learn more about ULTOMIRIS safety

What is the vaccination requirement for ULTOMIRIS?

Before starting your patients on ULTOMIRIS, review the vaccination requirements at the link below.

Learn more about vaccination requirements

Is there data on corticosteroid use in patients taking ULTOMIRIS?

ULTOMIRIS works differently from a steroid; review the corticosteroid usage data found in the brochure below.

Learn more about corticosteroid data and ULTOMIRIS

Support

How can patients afford ULTOMIRIS?

Eligible patients may pay as little as $0 for ULTOMIRIS. Patients must have commercial insurance. Please refer to the full terms and conditions for additional eligibility requirements.

Learn more about patient support

Is ULTOMIRIS covered by insurance?

Most commercially insured and Medicare generalized myasthenia gravis (gMG) patients have coverage for ULTOMIRIS. Restrictions may vary per region.a Contact your account representative or reach out to a Field Reimbursement Manager, with any questions about access in your region.8

aReview the payer policy to see the patient’s ULTOMIRIS coverage options.

Learn more about Alexion OneSource Patient Support

Is there a support program available?

The OneSource™ program is ready to help you help your patients by:

  • Helping navigate health insurance options
  • Ongoing support for patients and vaccination coordination
  • Providing complimentary education and connecting patients to the generalized myasthenia gravis (gMG) community

Learn more about OneSource

Where can I watch videos featuring key opinion leaders and other gMG experts discussing ULTOMIRIS?

Visit the online video library on this website to find multiple videos from experts sharing their insights about treatment, data, and much more.

Review the full video library

Are there any informational resources I can provide to my gMG patients about ULTOMIRIS?

To start educating your appropriate gMG patients about ULTOMIRIS, you can refer them to ULTOMIRISgMG.com, and provide them with downloadable resources like the Patient Brochure or Doctor Discussion guide, both available on this website.

Find resources for your patients

What if my staff or I have questions about access and reimbursement?

For answers to any access questions, please visit Alexion Access Navigator or connect with your local Field Reimbursement Manager (FRM) for more information.

Contact a FRM

NMJ, neuromuscular junction.

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)].

Alexion Connect

Healthcare Professionals: Answers to your questions are a phone call away!

Connect with a live ULTOMIRIS representative at 1-833-445-2111 or online at Contact an Account Manager.

Get 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
Intravenous administration 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 treated with ULTOMIRIS. These events included lower back pain, drop in blood pressure, limb discomfort, drug hypersensitivity (allergic reaction), dysgeusia (bad taste), and drowsiness. These reactions did not require discontinuation of ULTOMIRIS. If signs of cardiovascular instability or respiratory compromise occur, interrupt ULTOMIRIS infusion 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.

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 meningococcal infections/sepsis.

References:

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