ULTOMIRIS® (ravuizumab-cwvz) injection for intravenous use 300 mg/30 mL vial
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Important information regarding COVID-19 and access to your medicine

Alexion understands our patients and healthcare providers may be concerned about the evolving COVID-19 situation and our products.

ULTOMIRIS, built on the foundation of eculizumab, has an ~4x longer terminal half-life.2-4

ULTOMIRIS is administered every 8 weeks.3 The less frequent infusions and visits to hospitals/clinics associated with ULTOMIRIS vs eculizumab can potentially reduce exposure of paroxysmal nocturnal hemoglobinuria (PNH) patients, caregivers, and healthcare staff to high-risk environments by enabling social distancing.2-3

For most patients, the cost of medicine associated with ULTOMIRIS will be less than the costs of eculizumab on an ongoing, annual basis.*5

*The average annual cost of ongoing ULTOMIRIS treatment for atypical-HUS is at least 22% less than for Soliris treatment. For PNH, the average annual cost of ULTOMIRIS treatment is 10% less than for Soliris treatment. These figures are based on average wholesale acquisition cost (WAC) for patients ≥ 40 kg. Actual costs for individual patients will vary.

In the current COVID-19 pandemic, the American Society of Hematology (ASH) recommends that patients with PNH who require anti-complement therapy should stay on it because of the risk of serious and irreversible thrombosis. ULTOMIRIS, requiring administration only every 8 weeks, would be preferable over eculizumab to minimize visits to a physician’s office or infusion center [https://www.hematology.org/covid-19/covid-19-and-aplastic-anemia].

Based on Alexion’s understanding of the mechanism of action for ULTOMIRIS, and the extensive postmarketing experience (cumulatively, over 10 years of commercial distribution, and over 55,000 patient-years of exposure), it does not appear that patients treated with ULTOMIRIS are at higher risk of developing coronaviral infections or that the course of their infection will be different than in patients who have not received ULTOMIRIS.1-3

Viral respiratory infections were observed in the Alexion-sponsored clinical trials for ULTOMIRIS.4,5 Those viral respiratory infections were the same type of respiratory viral infections that are typically seen in the general population, like the common cold. In the trials, the viral respiratory infections were not serious in nature and all resolved without the patient having to discontinue treatment with ULTOMIRIS.

Infection has been shown to amplify complement activity, which could have the potential to exacerbate a patient’s underlying condition in a complement-mediated disease.6-9 It is also important to note that Soliris and ULTOMIRIS patients are at increased risk for developing meningococcal infections, which have some of the same early symptoms as COVID-19.4-5 While meningococcal infection could present as classic meningitis with fever, headache and neck stiffness, please note the presentation can also present as meningococcal sepsis without meningitis.1

Patients should be reminded that if they develop a headache and fever or have muscle aches with flu-like symptoms (or any symptoms as described on the “Patient Safety Card”), that they should call their doctor right away or seek emergency medical treatment, as these could be signs of a meningococcal infection that requires immediate medical attention. If patients cannot reach their doctor, immediately seek emergency medical treatment and show “Patient Safety Card” to emergency staff at the hospital.

Vaccination against Neisseria meningitidis is required before starting ULTOMIRIS therapy.4,5 Please refer to the latest ACIP guidelines for updated vaccine recommendations.

We made the decision to move our U.S. teams to full-time, remote work, with the exception of essential manufacturing and research teams. While you won’t see your account manager or medical science liaison at the office or in the hospital, know that we are a phone or video call away to support you and the people living with rare diseases who rely on our medicines. Your primary contact at Alexion will be in touch to ensure we know what you need, how we can help, and any preferences you may have as it relates to contact from us during this difficult time.

  1. Data on file. Alexion Pharmaceuticals, Inc.; 2019.
  2. SOLIRIS [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; June 2019.
  3. ULTOMIRIS [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; October 2019.
  4. Sheridan 2018/p13/para3/line8-10
  5. Levy, AR, et al. 2019
  6. Olie KH et al. Am J Kidney Dis. 2005;45(1):e12–e15
  7. Berner R et al. Pediatric Nephrology.2002;17(3):190–192.
  8. Brodsky RA et al. Haematologica. E-pub ahead of print, Jan 16, 2020.
  9. Ueda T et al. Journal of Nippon Medical School. 2013;80(2):155–159, Brodsky 2020/p12/para1/lines2-3
  10. EU Society of Bone Marrow and Transplant Patients, http://www.pnhleeds.co.uk/coronavirus/
  11. http://www.atypicalhus.co.uk/

Important update: Information on COVID-19 from Alexion.

IMPORTANT SAFETY INFORMATION & INDICATION for ULTOMIRIS® (ravulizumab-cwvz), INCLUDING BOXED WARNING

IMPORTANT SAFETY INFORMATION

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.

ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS, prescribers must enroll in the program. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com.

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

Risk and Prevention

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. If ULTOMIRIS must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis.

In clinical studies, 59 patients with PNH 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. In PNH clinical studies, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ULTOMIRIS; all 3 had been vaccinated. These 3 patients recovered while continuing treatment with ULTOMIRIS. Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection.

REMS
Under the ULTOMIRIS REMS, prescribers must enroll in the program due to the risk of meningococcal infections. 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.

Other Infections
Patients may have increased susceptibility to encapsulated bacteria infections, especially 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.

Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions. If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.

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 Reactions
Administration of ULTOMIRIS may result in infusion reactions. In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion reactions (lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure and limbs discomfort) during ULTOMIRIS administration which did not require discontinuation. Interrupt infusion and institute supportive measures if signs of cardiovascular instability or respiratory compromise occur.

ADVERSE REACTIONS
Adverse reactions reported in 5% or more of patients treated with ULTOMIRIS vs. Eculizumab was Upper respiratory tract infection (39% vs 39%), Headache (32% vs. 26%), Diarrhea (9% vs. 5%), Nausea (9% vs. 9%), Pyrexia (7% vs 8%), Pain in extremity (6% vs. 5%), Abdominal pain (6% vs. 7%), Dizziness (5% vs. 6%), Arthralgia (5% vs. 5%).

Serious adverse reactions were reported in 15 (6.8%) patients receiving ULTOMIRIS. The serious adverse reactions in patients treated with ULTOMIRIS included hyperthermia and pyrexia. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS.

One fatal case of sepsis was identified in a patient treated with ULTOMIRIS.

INDICATION

Paroxysmal Nocturnal Hemoglobinuria (PNH)
ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

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

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