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Patient Profiles

Patient types that may be appropriate for ULTOMIRIS®

 

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Meet Madison


A 32-year-old professional recently diagnosed with gMG and experiencing breakthrough symptomsa

Age: 32 | Profession: Social worker | Length of Disease: 8 months; treatment initiated upon diagnosis | Location: Cleveland, Ohio

Past medical history

  • Madison has no significant medical history except for a diagnosis of anti-AChR antibody-positive gMG 8 months ago
  • Madison has a family history of osteoporosis and diabetes mellitus

History of present illness

  • Madison’s disease progressed from oMG to gMG quickly, requiring a steroid and IST for management
  • MGFA class IIIa
  • MG-ADL total score: 6
  • Initially on low-dose steroids and IST; increased steroids to 80 mg per day due to incomplete response, then reduced to 40 mg per day due to steroid-related adverse reactions but has been unable to reduce further

Current medications

  • Prednisone 40 mg once per day
  • Azathioprine 150 mg once daily
  • Pyridostigmine 60 mg four times daily

Current chief complaints

  • Madison has an incomplete response to current therapies and is experiencing breakthrough symptoms of intermittent slurring of speech, increased shortness of breath upon exertion, and lower limb paresis
  • Madison is experiencing steroid-related adverse reactions including weight gain and increased acne
  • Madison is concerned about the increased risk of comorbidities and serious adverse reactions associated with long-term steroid use and ISTs

Meet Jacob


A 55-year-old father with gMG worried about treatment burdena

Age: 55 | Profession: Grocery clerk | Length of Disease: 2 years | Location: Boston, Massachusetts

Past medical history

  • Jacob has no significant medical history except for a diagnosis of anti-AChR antibody-positive gMG 2 years ago

History of present illness

  • He has been on an infusion therapy with concomitant steroids for the past 6 months
  • MGFA class IIa
  • His daily medication regimen previously included azathioprine, which was discontinued because he could not tolerate it
  • He was still experiencing gMG symptoms, which prompted more frequent doses of infusion therapy

Current medications

  • Frequent IV biologic therapy
  • Prednisone 20 mg once daily

Current chief complaints

  • Despite more frequent infusions, Jacob is still experiencing fluctuating and unpredictable symptoms between treatment doses, making it difficult to drive to work and keep up with his children’s extracurricular activities
  • Jacob has concerns about his current treatment regimen due to its unpredictable infusion schedules and frequent lengthy infusion center visits
  • Based on conversations with his doctor, Jacob is also interested in a treatment option that might allow him to lower or discontinue steroids

aPatient cases are fictitious and are not intended for diagnosis or treatment purposes.


AChR, acetylcholine receptor; gMG, generalized myasthenia gravis; IST, immunosuppressive therapy; MG-ADL, Myasthenia Gravis Activities of Daily Living; MGFA, Myasthenia Gravis Foundation of America; oMG, ocular myasthenia gravis; QMG, Quantitative Myasthenia Gravis.

ULTOMIRIS (ravulizumab‑cwvz) Efficacy

Find out the changes in MG-ADL and QMG total scores for patients in CHAMPION-MG.

View Efficacy Data

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening meningococcal infections/sepsis have occurred in patients treated with ULTOMIRIS. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a meningococcal infection. See Warnings and Precautions for additional guidance on the management of the risk of meningococcal infection.
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of 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 REMS.

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CONTRAINDICATIONS

  • Patients with unresolved Neisseria meningitidis infection.
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying ULTOMIRIS treatment outweigh the risks of developing a meningococcal infection.

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

Life-threatening meningococcal infections have occurred in patients treated with ULTOMIRIS. The use of ULTOMIRIS increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Meningococcal disease due to any serogroup may occur.

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without history of meningococcal vaccination at least 2 weeks prior to the first dose of ULTOMIRIS. Patients who initiate ULTOMIRIS treatment less than 2 weeks after receiving meningococcal vaccine(s) must receive appropriate prophylactic antibiotics until 2 weeks after vaccination.

In clinical studies, 2 adult patients with gMG were treated with ULTOMIRIS less than 2 weeks after meningococcal vaccination. All of these patients received antibiotics for prophylaxis of meningococcal infection until at least 2 weeks after meningococcal vaccination. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving ULTOMIRIS have not been established. Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection.

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

Under the ULTOMIRIS REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risk of meningococcal infection/sepsis, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines.

Additional information on the REMS requirements is available at www.ultomirisrems.com or 1-888-765-4747.

Other Infections
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. If ULTOMIRIS is administered to patients with active systemic infections, monitor closely for worsening infection.

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 of ULTOMIRIS may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1% of patients treated with ULTOMIRIS. These events included lower back pain, drop in blood pressure, elevation 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.

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

References:

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