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Considerations for starting your atypical-HUS patients on ULTOMIRIS

When you initiate or transition treatment with ULTOMIRIS, your patients with atypical-HUS can start to enjoy the freedom offered by a long-acting complement inhibitor.1

Learn how to start your treatment-naïve patients on ULTOMIRIS or transition your patients currently on eculizumab.

Only ULTOMIRIS offers patients living with atypical-HUS up to 8 weeks of freedom between infusions.1,a

Built on the foundation of eculizumab1,2

Harnessing the building blocks of eculizumab, ULTOMIRIS provides immediate, complete, and sustained complement inhibition in adult and pediatric patients.

Engineered for freedom1,2,b,c

With an ~4x longer half-life than eculizumab, ULTOMIRIS can offer sustained benefits, including more freedom between treatments—up to 8 weeks.

Designed for C5 degradation3

Engineered to release C5 in the endosome as pH levels drop and use FcRn to recycle back to the bloodstream, leaving C5 to be degraded by lysosomes.

For your newly diagnosed, treatment-naïve patients

case-study

Start your patients on ULTOMIRIS

When your adult or pediatric (1 month of age and older) patients are newly diagnosed with atypical-HUS, ULTOMIRIS is proven to provide long-acting complement control. ULTOMIRIS is not indicated for STEC-HUS.1

See how ULTOMIRIS can provide your newly diagnosed atypical-HUS patients with up to 8 weeks of freedom between treatments.

Download a case study, presented by Teri Mauch, MD, that follows the atypical-HUS diagnosis of Patrick, age 4, and his treatment journey with ULTOMIRIS.

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Transitioning to ULTOMIRIS from eculizumab

While ULTOMIRIS is built on the foundation of eculizumab, it differs in how it behaves after binding to C5.1-3,b,c

ULTOMIRIS

Engineered to bind to FcRn with
greater affinity with a
half-life ~4x longer
than eculizumab.

eculizumab

Binds to C5 and inhibits FcRn-mediated
recycling, leading to its
lysosomal degradation
along with C5.

By transitioning patients to ULTOMIRIS, they can achieve immediate, complete, and sustained inhibition of C5 for up to 8 weeks—giving them the freedom to enjoy the things they love.1,2

“You
can’t underestimate
the impact

the 8-week interval has on
patients’ lives.”

—Dr Patrick Foy

Considerations for transitioning to ULTOMIRIS from eculizumab

Here are a few straightforward steps you can take as you begin to transition your atypical-HUS patients to ULTOMIRIS.

Discuss

Discuss transitioning with the patient and obtain consent (evaluate patient prior to transitioning)

Detail the transition process with your patient, including the dosing regimen, what may happen if they experience an adverse reaction during the infusion, and how frequently you will monitor them during treatment.

Ensure

Ensure ULTOMIRIS is available and covered by the patient’s insurance

Depending on the institution, a pre-certification department or pharmacy team may coordinate with billing/insurance to ensure ULTOMIRIS is available for use in their patients.

Vaccinate

Vaccinate the patient for meningococcal disease according to current Advisory Committee on Immunization Practices (ACIP) guidelines to reduce the risk of serious infection

Pharmacists may manage the schedule for vaccine boosters to ensure patients are up-to-date with their vaccinations throughout treatment.

Set Appointment

Set appointment 2 weeks after the last dose of eculizumab to begin the first dose of ULTOMIRISd

With weight-based dosing, both physicians and pharmacists should confirm the appropriate ULTOMIRIS dose and schedule based on body weight.

“Every atypical-HUS patient
should be
considered as a candidate
for ULTOMIRIS.”

—Dr Patrick Foy

Leguizamo

Jorge Leguizamo, MD

Georgia Cancer Specialists
Atlanta, GA

foy

Patrick Foy, MD

Medical College of Wisconsin
Milwaukee, WI

Physicians are paid consultants of Alexion and they have been compensated for their time.

Expert Discussions:

Transitioning to ULTOMIRIS

There are several reasons to consider transitioning patients to ULTOMIRIS. We’ve published a perspective featuring two expert thought leaders—highlighting how they establish whether ULTOMIRIS is right for their atypical-HUS patients.e

DOWNLOAD NOW

Physicians are paid consultants of Alexion and they have been compensated for their time.

“One thing to keep in mind is
that the

dosing is based on weight.

—Dr Jorge Leguizamo

Eculizumab also has weight-based dosing.2

Transition dosing

ULTOMIRIS is a weight-based dose. The recommended dosing regimen in adult and pediatric patients 1 month of age or older with atypical-HUS weighing ≥5 kg consists of a loading dose followed by maintenance doses, administered by intravenous infusion.1

dosing-chart dosing-chart
USE DOSING CALCULATOR TOOL

Talk to your patients about transitioning to ULTOMIRIS

Help your patients understand the benefits of transitioning with easy-to-understand answers to frequently asked questions.

DOWNLOAD THE FAQ

See the ULTOMIRIS efficacy and safety data

ULTOMIRIS is the first and only long-acting complement inhibitor—providing up to 8 weeks of freedom between infusions.1,a

REVIEW ADULT DATA REVIEW PEDIATRIC DATA

aStarting 2 weeks after the initial loading dose, maintenance doses are administered every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight).

bThe mean (%CV) terminal elimination half-life and clearance of ULTOMIRIS in patients with atypical-HUS are 51.8 (31.3) days and 0.08 (53.3) L/day, respectively. Half-life of eculizumab is 11.25 to 17.25 days.1,2

cTargeted engineering to incorporate 4 amino acid substitutions designed to reduce target-mediated drug disposition (TMDD) and enhance FcRn-mediated recycling into eculizumab has led to the generation of ULTOMIRIS, which exhibited an extended duration of action in preclinical models relative to eculizumab.

dFor patients switching from eculizumab to ULTOMIRIS, administer the loading dose of ULTOMIRIS 2 weeks after the last eculizumab infusion, and then administer ULTOMIRIS maintenance doses once every 4 weeks or every 8 weeks (depending on body weight), starting 2 weeks after loading dose.

eThis information is based on live interviews with 2 physicians who have collectively treated or consulted as a second opinion on >50 patients diagnosed with atypical-HUS.

References:
  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. SOLIRIS. [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2020.
  3. Sheridan D, et al. PLoS One. 2018;13(4):e0195909.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

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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. 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.

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. 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.

Infusion-Related Reactions
Administration of ULTOMIRIS may result in infusion-related reactions including anaphylaxis and hypersensitivity 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.

ADVERSE REACTIONS
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 and in 3% of adult patients include infusion-related reactions.

INDICATION
ULTOMIRIS is indicated for the treatment of adult 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).

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

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Healthcare Professionals:
Answers to your questions are
a phone call away! Connect
with a live representative.
833-551-2539

Alexion Connect

Alexion Connect

Healthcare Professionals:
Answers to your questions are
a phone call away! Connect
with a live representative.
833-551-2539

Alexion Connect