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For your adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Control the journey ahead. Based on the MG-ADL, Myasthenia Gravis Activities of Daily Living, a categorical scale that assesses the impact on daily function of 8 signs or symptoms that are typically affected in gMG.

ULTOMIRIS®—symptom control for the journey ahead1-4

  • The first and only long-acting C5 inhibitor1,5,6
  • Demonstrated a statistically significant improvement in MG-ADL total score from baseline at Week 26 compared to placebo (-3.1 for ULTOMIRIS vs -1.4 for placebo, [P<0.001])1,b
  • Predictable, once-every-8-week maintenance dosing1,c
  • Studied in >600 patients across 6 clinical trials and across 3 rare, complement-mediated diseases1

bMean (SD) MG-ADL total score at baseline was 8.9 (2.3) for placebo (n=89) and 9.1 (2.6) for ULTOMIRIS (n=86).2

cOnce-every-8-week dosing after loading dose.1

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MG-ADL, Myasthenia Gravis Activities of Daily Living; SD, standard deviation.

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.

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

Reference

  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  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. Howard JF Jr, et al. Poster presented at: AAN 2022 Annual Meeting; April 2-7, 2022; Seattle, WA.
  4. Vu T, et al. Presented at: AAN 2022 Annual Meeting; April 2-7, 2022; Seattle, WA.
  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. Howard JF Jr, et al. Poster presented at: AAN 2022 Annual Meeting; April 2-7, 2022; Seattle, WA.
  5. Kulasekararaj AG, et al. Blood. 2019;133(6):540-549.
  6. Lee JW, et al. Blood. 2019;133(6):530-539.
  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. Howard JF Jr. Ann N Y Acad Sci. 2018;1412(1):113-128.
  5. Conti-Fine BM, et al. J Clin Invest. 2006;116(11):2843-2854.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Centers for Disease Control and Prevention. Updated October 12, 2021. Accessed April 27, 2022. https://www.cdc.gov/vaccines/vpd/mening/public
  3. Centers for Disease Control and Prevention. Updated February 17, 2022. Accessed April 27, 2022. https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Howard JF Jr, et al. Poster presented at: AAN 2022 Annual Meeting; April 2-7, 2022; Seattle, WA.
  3. Data on file. Alexion Pharmaceuticals, Inc.
  4. Vu T, et al. Presented at: AAN 2022 Annual Meeting; April 2-7, 2022; Seattle, WA.
  5. 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.