ULTOMIRIS® (ravulizumab-cwvz) Injection for intravenous use 300 mg/30 mL vial
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Get continuous protection that lasts up to 8 weeks between infusions with ULTOMIRIS1,a

aStarting 2 weeks after the loading dose, maintenance doses are administered once every 4 or 8 weeks (depending on body weight).1

Getting your patients with atypical‑HUS started on their ULTOMIRIS treatment journey begins with understanding the ULTOMIRIS weight-based dosing regimen. Become familiar with the dosing details to help your patients navigate their path to treatment.

For treatment of atypical-HUS in adults and pediatric patients 1 month of age and older. Not indicated in STEC‑HUS.1

An overview: ULTOMIRIS dosing

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

Initiating ULTOMIRIS with no prior treatment

Loading dose of ULTOMIRIS should be administered as outlined below

Maintenance doses are administered once every 4 or 8 weeks (depending on body weight), starting 2 weeks after the loading dose

Switching to ULTOMIRIS from Soliris® (eculizumab) therapy

Loading dose of ULTOMIRIS should be administered as outlined below, 2 weeks after the last Soliris infusion

Maintenance doses are administered once every 4 or 8 weeks (depending on body weight), starting 2 weeks after the loading dose

Calculate: Atypical‑HUS weight-based dosing1

Enter a patient’s body weight at the time of treatment to determine the appropriate loading and maintenance doses as well as the frequency of the maintenance dose.

Enter patient weight

Clear form
XXXXmg
XXXXmg every X weeks
This calculator tool is for reference only. See the full dosing chart below and the recommended weight-based dosing regimen for atypical-HUS in section 2.3 of the ULTOMIRIS Prescribing Information.
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bStarting 2 weeks after the loading dose, maintenance doses are administered once every 4 or 8 weeks (depending on body weight).1

cThe dosing schedule is allowed to occasionally vary within 7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS); but the subsequent doses should be administered according to the original schedule.1

Preparing and administering the ULTOMIRIS infusion

Steps to prepare ULTOMIRIS1 (part 1)

  • Step 1 Weigh patient
  • Step 2 Determine how many ULTOMIRIS vials are needed based on patient weight and prescribed dose (see reference tables below)
    • Vials should be stored at refrigeration (2°C – 8°C, 36°F – 46°F), protected from light
    • Each vial of ULTOMIRIS is intended for single-dose only
  • Step 3Allow ULTOMIRIS vials to come to room temperature (18°C – 25°C, 64°F – 77°F) naturally without using any heat source
  • Step 4Visually inspect each ULTOMIRIS vial to be sure there is no particulate or precipitate (if either, do not use)
  • Step 5 Using aseptic technique, withdraw the volume of ULTOMIRIS (corresponding to the prescribed dose) from the appropriate number of vials and add to an equal volume (1:1) of 0.9% Sodium Chloride Injection, USP, in an infusion bag (see reference tables below)
    • Each ULTOMIRIS vial contains 30 mL (10 mg/mL); vials are diluted 1:1 with NaCl for a final infusion concentration of 5 mg/mL
  • Step 6Gently mix the solution by swirling (do not shake or introduce air bubbles)

Steps to administer ULTOMIRIS1 (part 2)

  • Step 7 Administer the solution immediately to the patient through a 0.2 or 0.22 micron filter
    • If the solution is not administered immediately, the solution can be stored at refrigeration (2°C-8°C, 36°F-46°F) for ≤24 hours, taking into account the expected infusion time. Do not freeze the solution
    • When administering stored (refrigerated) solution, be sure to bring to room temperature naturally before administering, and be sure to administer within 6 hours
  • Step 8 The length of infusion time will vary based on the dose as determined by the patient’s weight, but the rate of infusion should not exceed the maximum for each dose (see reference tables below)
  • Step 9 Monitor patient for 1 hour following infusion to ensure no signs or symptoms of an infusion reaction occur
    • If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Interrupt ULTOMIRIS infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur
    • Some signs of infusion reaction include: lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure, and limb discomfort
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dBody weight at time of treatment.1

eDilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USP.1

How to: Infuse ULTOMIRIS

Learn the step-by-step instructions for how to properly prepare and administer the ULTOMIRIS infusion.

Download: The pocket dosing guide

This short, helpful dosing guide is available for you to have on hand to help inform the dosing recommendations for your patients with atypical‑HUS starting on their treatment journey.

DOWNLOAD DOSING GUIDE VIEW OTHER RESOURCES

Important vaccination information1

Enroll in ULTOMIRIS REMS

Due to the risk of meningococcal infections, 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.

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.

Enrollment in the ULTOMIRIS REMS and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com.

Vaccinate to reduce infection risk

Vaccinate patients for meningococcal disease according to current ACIP guidelines to reduce the risk of serious infection.

Provide 2 weeks of antibacterial drug prophylaxis to patients if ULTOMIRIS must be initiated immediately and vaccines are administered less than 2 weeks before starting ULTOMIRIS therapy.

Be on the lookout: Meningococcal infection1

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection.

Individualizing ULTOMIRIS treatment duration1

Read through these discontinuation considerations so you can best plan for the treatment road ahead for your patients with atypical‑HUS.

Minimum duration
6 months

ULTOMIRIS treatment of atypical‑HUS should be a minimum duration of 6 months.

Due to the heterogeneous nature of atypical‑HUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized.

Ongoing monitoring
12 months

If the patient discontinues treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months.

There are no specific data on ULTOMIRIS discontinuation.

Post-discontinuation TMA complications

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 2 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
  • An increase in serum LDH of 25% or more as compared to baseline or to nadir during ULTOMIRIS treatment

Rate of TMA post-discontinuation

13.5-fold higher rate of TMA was seen in patients who discontinued complement inhibitor therapy vs patients who stayed on therapy.2,f

Patients at the highest risk for TMA post-discontinuation included those with pediatric disease onset, genetic or autoimmune complement abnormalities, and a history of multiple TMAs.

The study showed a trend toward reduced renal function compared to patients who continued treatment.

fIn a long-term prospective, observational study of Soliris.2 There is no specific data on discontinuation of ULTOMIRIS.1

If TMA complications occur after ULTOMIRIS discontinuation, consider reinitiation of ULTOMIRIS treatment or appropriate organ-specific supportive measures

ULTOMIRIS efficacy and safety

Get the details on how ULTOMIRIS inhibited complement activation in adult and pediatric patients.

REVIEW ADULT DATA REVIEW PEDIATRIC DATA

Discover the ULTOMIRIS difference

Learn what makes ULTOMIRIS different from Soliris.

EXPLORE THE MOA
References:
  1. ULTOMIRIS [prescribing information]. Boston, MA: Alexion Pharmaceuticals, Inc.; 2020.
  2. Menne J, et al. BMC Nephrol. 2019;20(1):125.

Now FDA approved 100 mg/mL formulation: get the details

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. In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion-related 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
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.

INDICATION
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).

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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