Important information regarding COVID-19 and access to 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 Soliris® (eculizumab), has a ~4x longer terminal half-life.1-3
ULTOMIRIS is administered every 4 or 8 weeks (depending on body weight).1 The less frequent infusions and visits to hospitals/clinics associated with ULTOMIRIS vs. Soliris1,2 can potentially reduce exposure of atypical-HUS patients, caregivers, and healthcare staff to high-risk environments by enabling social distancing.
For most patients, the cost of medicine associated with ULTOMIRIS will be less than the cost of Soliris on an ongoing, annual basis.4*
Infections, including viral infections, have been shown to amplify complement activity, which could have the potential to exacerbate a patient’s condition in an underlying complement-driven disease.5-9 Patients with aHUS receiving Soliris should continue to receive their treatment during the COVID-19 pandemic.10 Patients with aHUS receiving ULTOMIRIS, built on the foundation of Soliris, should continue treatment as well.3
We made the decision to move our US teams to full-time, remote work, with the exception of essential manufacturing and research teams. While you will not 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.
*The average annual cost of ongoing ULTOMIRIS treatment for atypical-HUS is at least 22% less than Soliris treatment. For PNH, the average annual cost of ULTOMIRIS treatment is 10% less than Soliris treatment. These figures are based on average wholesale acquisition cost (WAC) for patients ≥40 kg. Actual costs for individual patients will vary.
- ULTOMIRIS [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc. 2021.
- Soliris [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc. 2020.
- Sheridan D, et al. PLoS One. 2018;13(4):e0195909.
- Levy AR, et al. Value in Health. 2019;22(Suppl2):S377.
- Data on file. Alexion Pharmaceuticals, Inc.; 2019.
- Olie KH, et al. Am J Kidney Dis. 2005;45(1):e12–e15.
- Berner R, et al. Pediatr Nephrol. 2002;17(3):190–192.
- Brodsky RA, et al. Haematologica. E-pub ahead of print, Jan 16, 2020.
- Ueda T, et al. J Nippon Med Sch. 2013;80(2):155–159.
- National Renal Complement Therapeutics Centre. https://www.atypicalhus.co.uk/about-us/latest-news/. Accessed Nov 2020.
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.
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.
- 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. 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.
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.
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. Children treated with ULTOMIRIS may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. If ULTOMIRIS is administered to patients with active systemic infections, monitor closely for worsening infection.
Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. There are no specific data on ULTOMIRIS discontinuation. After discontinuing treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months.
TMA complications post-discontinuation can be identified if any of the following is observed: Clinical symptoms of TMA include changes in mental status, seizures, angina, dyspnea, thrombosis or increasing blood pressure. In addition, at least two of the following laboratory signs observed concurrently and results should be confirmed by a second measurement 28 days apart with no interruption: a decrease in platelet count of 25% or more as compared to either baseline or to peak platelet count during ULTOMIRIS treatment; an increase in serum creatinine of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment; or, an increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment. If TMA complications occur after discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organ-specific supportive measures.
Thromboembolic Event Management
The effect of withdrawal of anticoagulant therapy during treatment with ULTOMIRIS has not been established. Treatment should not alter anticoagulant management.
Administration of ULTOMIRIS may result in infusion-related reactions. In clinical trials, 4 out of 309 patients treated with ULTOMIRIS experienced infusion-related reactions (lower back pain, drop in blood pressure, elevation in blood pressure and limb discomfort) during ULTOMIRIS administration which did not require discontinuation. Interrupt infusion and institute supportive measures if signs of cardiovascular instability or respiratory compromise occur.
Most common adverse reactions in patients with aHUS (incidence ≥20%) were upper respiratory tract infection, diarrhea, nausea, vomiting, headache, hypertension and pyrexia. Serious adverse reactions were reported in 42 (57%) patients with aHUS receiving ULTOMIRIS. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia and abdominal pain. In clinical studies, clinically relevant adverse reactions in <10% of patients include viral tonsillitis in adults and viral infection in pediatric patients.
ULTOMIRIS is indicated for the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Limitation of Use:
ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC‑HUS).