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Patient & Practice Resources

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Tools and information for you and your adult patients with generalized myasthenia gravis (gMG)

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HCP Resources

HCP Starter Kit

A kit designed to help you and your practice start the initiation process. This resource details how to start your patients on ULTOMIRIS® (ravulizumab-cwvz), including information about:

  • The Initiation Roadmap
  • Dosing regimen
  • Infusion information
  • REMS program
  • OneSource™ patient support

and more.

Download: HCP Starter Kit

Dosing and Administration Guide

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

Download: Dosing and Administration Guide

Vaccination Q&A Brochure

Answers to common questions about the vaccination requirements for ULTOMIRIS treatment.

Download: Vaccination Q&A Brochure

Assessment Tool Booklet

Tools to help you and your practice track patients’ symptoms over time.

Download: Assessment Tool Booklet

Initiation Guide

This comprehensive resource provides an overview of topics when commencing treatment for gMG, such as prescribing ULTOMIRIS for appropriate patients; dosing guidelines, including weight-based dosing; ordering, storing, and administering ULTOMIRIS; vaccination prior to ULTOMIRIS treatment; the REMS program; OneSource; and the CoPay Program.

Download: Initiation Guide

HCP Patient Discussion Guide

A discussion guide that provides patient-friendly answers to frequently asked questions about ULTOMIRIS.

Download: HCP Patient Discussion Guide

ULTOMIRIS Safety and Efficacy Brochure

This brochure provides further details on the safety profile and efficacy data of ULTOMIRIS.

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

Access and Coverage Guide

This provides details about the access opportunities that gMG patients nationwide have available to them.

Download: Access and Coverage Guide

Patient Case Study: Using ULTOMIRIS in Recently Diagnosed Patients

Do you have gMG patients like Madison? Learn about her story and the types of patients for whom ULTOMIRIS might be appropriate.

Download: “Do you have patients like Madison?” Brochure

Guide to ULTOMIRIS and Corticosteroids in gMG

A brochure detailing the data on use of corticosteroids, and concomitant treatment with ULTOMIRIS.

Download: Guide to ULTOMIRIS and Corticosteroids in gMG

ULTOMIRIS Clinical Pharmacology Brochure

A brochure featuring ULTOMIRIS PK/PD data, including analysis of ULTOMIRIS data in anti-AChR antibody-positive gMG captured throughout the CHAMPION study.

Considerations for Switching gMG Therapies

A pamphlet providing an overview for switching to ULTOMIRIS from another treatment.

Patient Resources

Vaccination Card

As part of the REMS program, this card highlights the risk of meningococcal infection for gMG patients taking ULTOMIRIS® (ravulizumab-cwvz) and underscores the importance of meningococcal vaccination.

Download: Vaccination Card

Patient ER Checklist

Patients treated with ULTOMIRIS should bring this resource with them on arrival to an emergency room for use by physicians and/or first responders.

Download: Patient ER Checklist

Patient Brochure

This brochure provides patients and caregivers with clear, concise information about ULTOMIRIS, including how it works and what they can expect when starting treatment.

Download: Patient Brochure

REMS Patient Safety Brochure

As part of the REMS program, it is essential to inform patients on ULTOMIRIS about the risk of meningococcal infection and steps to take in the case of adverse events.

Download: REMS Patient Safety Brochure

REMS Healthcare Provider Safety Brochure

This brochure provides information for healthcare providers who will prescribe or dispense ULTOMIRIS.

Download: REMS Healthcare Provider Safety Brochure

REMS Patient Safety Card

A feature of the REMS program, this card highlights the risk of meningococcal infection for gMG patients taking ULTOMIRIS and provides them information should adverse events occur.

Download: REMS Patient Safety Card

Patient-Doctor Discussion Guide

This guide provides patients with some common questions and talking points to discuss at their next healthcare appointment.

Download: Patient-Doctor Discussion Guide

AChR, anti-acetylcholine receptor; PD, pharmacodynamics; PK, pharmacokinetics; REMS, Risk Evaluation and Mitigation Strategy.

Need help starting patients on ULTOMIRIS, additional resources, or ongoing support?

Contact an Alexion Account Manager

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:

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  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.
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  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.
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