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NOW APPROVED for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).1

Dosing and administration for atypical-HUS and PNH

Intravenous infusion
every 4 or 8 weeks


In-clinic or at-home infusion of ULTOMIRIS for atypical-HUS or PNH is administered intravenously every 8 weeks for adult patients and every 4 or 8 weeks for pediatric patients, depending on body weight.1

Actor portrayal

Designed to provide continuous C5 inhibition that lasts up to 8 weeks between infusions1,a


Getting your patients 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.


aStarting 2 weeks after the intravenous loading dose, maintenance doses are infused intravenously every 8 weeks for adult patients and every 4 or 8 weeks for pediatric patients (depending on body weight).1

C5=complement protein 5.

Review important vaccination information

ULTOMIRIS 100 mg/mL dosing overview

Patients starting ULTOMIRIS with no prior treatment

Starting 2 weeks after the intravenous loading dose, maintenance doses are infused intravenously once every 4 or 8 weeks (depending on body weight).

Patients switching from eculizumab to ULTOMIRIS

A loading dose of ULTOMIRIS should be infused intravenously at the time of the next scheduled eculizumab dose. Maintenance doses are infused intravenously once every 4 or 8 weeks (depending on body weight), starting 2 weeks after the loading dose.

Weight-based dosing calculator1

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.

Weight-based 100 mg/mL dosing calculator for adult patients

Patient weight

This calculator tool is for reference only. See the full dosing chart below and the recommended weight-based dosing regimen in section 2.3 of the ULTOMIRIS Prescribing Information.

Dosing table (weight-based 100 mg/mL dosing regimen)1,b-d

Body weight range (kg) Loading dose (mg) Loading dose
ULTOMIRIS
300 mg/3 mL vials
Maintenance dose (mg)
and dosing interval
Maintenance dose ULTOMIRIS vial combinations
1100 mg/11 mL 300 mg/3 mL
5 to <10 600 2 300 Every
4 weeks
1
10 to <20 600 2 600 2
20 to <30 900 3 2100 Every
8 weeks
7
30 to <40 1200 4 2700 9
40 to <60 2400 8 3000 10
60 to <100 2700 9 3300 3
100 or greater 3000 10 3600 3 1
Swipe to view full table

bStarting 2 weeks after the intravenous loading dose, maintenance doses are infused intravenously every 8 weeks for adult patients and every 4 or 8 weeks for pediatric patients (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). Subsequent doses should be administered according to the original schedule.1

dAdministration of PE/PI (plasmapheresis or plasma exchange or fresh frozen plasma infusion) may reduce ULTOMIRIS serum levels. There is no experience with administration of supplemental doses of ULTOMIRIS.1

Continue ULTOMIRIS treatment to sustain clinical
benefits with appropriate patients

Patients prefer the less frequent doses of ULTOMIRIS over the more frequent doses of eculizumab

ULTOMIRIS is preferred over a more frequently infused complement inhibitor.2,e 93% (88/95) of patients who switched from eculizumab in a clinical study preferred ULTOMIRIS.1,f

eIn a patient population diagnosed with PNH.

fIn substudy ALXN1210-PNH-302s, 95 patients enrolled in the extension period of the ULTOMIRIS switch study (ALXN1210-PNH-302; NCT03056040) completed the Paroxysmal Nocturnal Hemoglobinuria Patient Preference Questionnaire (PNH-PPQ©) to report on their overall treatment preference and the treatment characteristics that were most important to that preference.

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 under refrigeration (2°C–8°C, 36°F–46°F), protected from light
  • Each vial of ULTOMIRIS is intended for single dose only

Step 3

Visually inspect each ULTOMIRIS vial to be sure there is no particulate matter or
precipitate (if either, do not use)

Step 4

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)

  • ULTOMIRIS is supplied in 2 single-dose vials (1100 mg/11 mL and 300 mg/3 mL) to enable an optimal vial mix for each weight cohort, ensuring there is no product wastage
  • ULTOMIRIS requires dilution to a final concentration of 50 mg/mL for the 3 mL and 11 mL vials

Step 5

Gently mix the solution by swirling (do not shake or introduce air bubbles) and protect from light

Step 6

Prior to administration, allow the admixture to adjust to room temperature (18°C–25°C, 64°F–77°F). Do not heat the admixture in a microwave or with any heat source other than ambient air temperature

Step 7

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

Steps to administer ULTOMIRIS1 (part 2)

Step 8

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 under refrigeration at (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 4 hours

Step 9

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 10

Monitor patient for at least 1 hour following infusion to ensure no signs or symptoms of an infusion-related 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-related reaction include lower back pain, drop in blood pressure, elevation in blood pressure, limb discomfort, drug hypersensitivity (allergic reaction), dysgeusia (bad taste), and drowsiness

Administration reference tables for the 100 mg/mL formulation1,g,h

Loading dose administration details
Body weight
rangeg (kg)
ULTOMIRIS volume
(vials)
Volume of
0.9% NaClh
Total volume
(dose)
Minimum infusion
time (hr)
Maximum infusion
rate (mL/hr)
5 to <10 6 mL (2 vials) 6 mL 12 mL (600 mg) 1.4 9
10 to <20 6 mL (2 vials) 6 mL 12 mL (600 mg) 0.8 15
20 to <30 9 mL (3 vials) 9 mL 18 mL (900 mg) 0.6 30
30 to <40 12 mL (4 vials) 12 mL 24 mL (1200 mg) 0.5 48
40 to <60 24 mL (8 vials) 24 mL 48 mL (2400 mg) 0.8 60
60 to <100 27 mL (9 vials) 27 mL 54 mL (2700 mg) 0.6 90
100 or greater 30 mL (10 vials) 30 mL 60 mL (3000 mg) 0.4 150
Maintenance dose administration details
Body weight
rangeg (kg)
ULTOMIRIS volume
(vials)
Volume of
0.9% NaClh
Total volume
(dose)
Minimum infusion
time (hr)
Maximum infusion
rate (mL/hr)
5 to <10 3 mL (1 vial) 3 mL 6 mL (300 mg) 0.8 8
10 to <20 6 mL (2 vials) 6 mL 12 mL (600 mg) 0.8 15
20 to <30 21 mL (7 vials) 21 mL 42 mL (2100 mg) 1.3 33
30 to <40 27 mL (9 vials) 27 mL 54 mL (2700 mg) 1.1 50
40 to <60 30 mL (10 vials) 30 mL 60 mL (3000 mg) 0.9 67
60 to <100 33 mL (3 11-mL vials) 33 mL 66 mL (3300 mg) 0.7 95
100 or greater 36 mL (3 11-mL vials,
1 3-mL vial)
36 mL 72 mL (3600 mg) 0.5 144
Swipe to view full table

gBody weight at time of treatment.1

hDilute ULTOMIRIS only using 0.9% Sodium Chloride Injection, USPI.1

See how to infuse ULTOMIRIS 100 mg/mL

Learn the step-by-step instructions for how to properly prepare and administer the ULTOMIRIS 100 mg/mL infusion.

VIEW ULTOMIRIS DOSING ONE-SHEET

The pocket dosing guide for intravenous ULTOMIRIS

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 or PNH starting on their treatment journey.

DOWNLOAD DOSING GUIDE VIEW OTHER RESOURCES

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Important vaccination information1


Enroll in the REMS program called ULTOMIRIS and SOLIRIS 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 REMS program, prescribers must enroll in the program. Healthcare settings and pharmacies that dispense ULTOMIRIS must be certified in the REMS and must verify prescribers are certified.

Prescribers must counsel patients about the risk of meningococcal infection/sepsis, provide the patients with the REMS educational materials, and assess vaccination status for meningococcal vaccines. Patients must be instructed to carry the Patient Safety Card with them at all times during and for 8 months following treatment with ULTOMIRIS.

Enrollment in the REMS program and additional information are available at 1-888-765-4747 or online.

Vaccinate to reduce infection risk

Vaccinate and revaccinate patients two weeks prior to first dose of ULTOMIRIS in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information.1

If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible.1

Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.1

References:

  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Peipert JD, et al. PLoS One. 2020;15(9):e0237497.
IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

ULTOMIRIS, a complement inhibitor, increases the risk of serious infections caused by Neisseria meningitidis [see Warnings and Precautions (5.1)] Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

  • Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for  vaccinations against meningococcal bacteria in patients receiving a complement inhibitor.  See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
  • Patients receiving ULTOMIRIS are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination.  Monitor patients for early signs and symptoms of serious 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 and SOLIRIS REMS [see Warnings and Precautions (5.2)].

CONTRAINDICATIONS

  • Initiation in patients with unresolved serious Neisseria meningitidis infection.

WARNINGS AND PRECAUTIONS
Serious Meningococcal Infections

ULTOMIRIS, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by meningococcal bacteria (septicemia and/or meningitis) in any serogroup, including non-groupable strains. Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.

Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy. Note that ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent ULTOMIRIS therapy is indicated in a patient who is not up to date with meningococcal vaccines according to ACIP recommendations, provide antibacterial drug prophylaxis and administer meningococcal vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including ULTOMIRIS. The benefits and risks of treatment with ULTOMIRIS, as well as those associated with antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by Neisseria meningitidis.

Vaccination does not eliminate the risk of serious meningococcal infections, despite development of antibodies following vaccination.

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 instruct patients to seek immediate medical care if they occur. Promptly treat known infections.  Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection depending on the risks of interrupting treatment in the disease being treated.

ULTOMIRIS and SOLIRIS REMS
Due to the risk of serious meningococcal infections, ULTOMIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.

Prescribers must enroll in the REMS, counsel patients about the risk of serious meningococcal infection, provide patients with the REMS educational materials, assess patient vaccination status for meningococcal vaccines (against serogroups A, C, W, Y, and B) and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of ULTOMIRIS. Antibacterial drug prophylaxis must be prescribed if treatment must be started urgently, and the patient is not up to date with both meningococcal vaccines according to current ACIP recommendations at least two weeks prior to the first dose of ULTOMIRIS. Patients must receive counseling about the need to receive meningococcal vaccines and to take antibiotics as directed, signs and symptoms of meningococcal infection, and be instructed to carry the Patient Safety Card at all times during and for 8 months following ULTOMIRIS treatment.

Further information is available at www.UltSolREMS.com or 1-888-765-4747.

Other Infections
Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

ULTOMIRIS blocks terminal complement activation; therefore, 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. 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 recommendations. Patients receiving ULTOMIRIS are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after ULTOMIRIS Discontinuation
Treatment Discontinuation for PNH
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.

Treatment Discontinuation for aHUS
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
Intravenous administration may result in systemic infusion-related reactions, including anaphylaxis and hypersensitivity reactions. In clinical trials, infusion-related reactions occurred in approximately 1 to 7% of patients treated with ULTOMIRIS.  These events included lower back pain, drop 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
Adverse Reactions for PNH
Adverse reactions reported in ≥10% or more of patients with PNH were upper respiratory tract infection and headache. 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. In clinical studies, clinically relevant adverse reactions in 1% of adult patients include infusion-related reactions.

Adverse reactions reported in ≥10% of pediatric patients treated with ULTOMIRIS who were treatment-naïve vs. Eculizumab-experienced were anemia (20% vs. 25%), abdominal pain (0% vs. 38%), constipation (0% vs. 25%), pyrexia (20% vs. 13%), upper respiratory tract infection (20% vs. 75%), pain in extremity (0% vs. 25%), and headache (20% vs. 25%).

Adverse Reactions for aHUS
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.

Adverse reactions reported in 20% of pediatric patients treated with ULTOMIRIS were diarrhea, constipation, vomiting, pyrexia, upper respiratory tract infection, decreased vitamin D, headache, cough, rash, and hypertension.

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.

INDICATIONS
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ULTOMIRIS is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).

Atypical Hemolytic Uremic Syndrome (aHUS)
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).

To report SUSPECTED ADVERSE REACTIONS, contact Alexion Pharmaceuticals, Inc. at 1-844-259-6783 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

References

  1. ULTOMIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.
  2. Lee JW, et al. Blood. 2019;133(6):530-539.
  3. Kulasekararaj AG, et al. Blood. 2019;133(6):540-549.
  4. Data on file. Alexion Pharmaceuticals, Inc. 2021.