What is Ultomiris, and how does it work?

Ultomiris is a prescription medicine called a monoclonal antibody. Ultomiris is used to treat:

It is not known if Ultomiris is safe and effective in children with PNH.

It is not known if Ultomiris is safe and effective in children younger than 1 month of age.

What are the side effects of Ultomiris?

Ultomiris can cause serious side effects including:

  • Infusion reactions. Infusion reactions may happen during your Ultomiris infusion. Symptoms of an infusion reaction with Ultomiris may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your Ultomiris infusion that may mean you are having a serious infusion reaction, including:

Your doctor will treat your symptoms as needed.

The most common side effects of Ultomiris in people treated for PNH are upper respiratory infection and headache.

The most common side effects of Ultomiris in people with aHUS are:

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ultomiris. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.
  • 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: 1-844-259-6783 or at www.Ultomirisrems.com.

What is the dosage for Ultomiris?

Recommended Vaccination And Prophylaxis

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.

Healthcare professionals who prescribe Ultomiris must enroll in the Ultomiris REMS.

Recommended Weight-Based Dosage Regimen - PNH

The recommended dosing regimen in adult patients with PNH weighing 40 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. Administer the doses based on the patient's body weight, as shown in Table 1. Starting 2 weeks after the loading dose administration, begin maintenance doses at a once every 8-week interval.

The 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.

Table 1: Ultomiris Weight-Based Dosing Regimen - PNH

Body Weight Range (kg)Loading Dose (mg)Maintenance Dose (mg) and Dosing Interval
greater than or equal to 40 to less than 602,4003,000Every 8 weeks
greater than or equal to 60 to less than 1002,7003,300
greater than or equal to 1003,0003,600

Recommended Weight-Based Dosage Regimen - aHUS

The recommended dosing regimen in adult and pediatric patients one month of age and older with aHUS weighing 5 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. Administer the doses based on the patient's body weight, as shown in Table 2. Starting 2 weeks after the loading dose administration, begin maintenance doses once every 8 weeks or every 4 weeks (depending on body weight).

The 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.

Table 2: Ultomiris Weight-Based Dosing Regimen - aHUS

Body Weight Range (kg)Loading Dose (mg)Maintenance Dose (mg) and Dosing Interval
greater than or equal to 5 to less than 10600300Every 4 weeks
greater than or equal to 10 to less than 20600600
greater than or equal to 20 to less than 309002,100Every 8 weeks
greater than or equal to 30 to less than 401,2002,700
greater than or equal to 40 to less than 602,4003,000
greater than or equal to 60 to less than 1002,7003,300
greater than or equal to 1003,0003,600

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What drugs interact with Ultomiris?

No Information provided

Is Ultomiris safe to use while pregnant or breastfeeding?

  • There are no available data on Ultomiris use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
  • There are risks to the mother and fetus associated with untreated PNH and aHUS in pregnancy.
  • There are no data on the presence of ravulizumab-cwvz in human milk, the effect on the breastfed child, or the effect on milk production.
  • Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in a nursing child, breastfeeding should be discontinued during treatment and for 8 months after the final dose.

Summary

Ultomiris is a prescription medicine called a monoclonal antibody. Ultomiris is used to treat adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH) and adults and children 1 month of age and older with a disease called atypical hemolytic uremic syndrome (aHUS). Ultomiris is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Treatment & Diagnosis

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Medically Reviewed on 10/21/2020
References
All sections courtesy of the U.S. Food and Drug Administration