Generic drug: eculizumab

Brand name: Soliris

What is Soliris (eculizumab), and how does it work?

Soliris (eculizumab) is a prescription medicine called a monoclonal antibody. Soliris is used to treat:

  • patients-with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Soliris is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STECHUS).
  • adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive
  • adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

It is not known if Soliris is safe and effective in children with PNH, gMG, or NMOSD.

What are the side effects of Soliris?

WARNING

SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. 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 Soliris, unless the risks of delaying Soliris 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.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-Soliris (1888-765-4747) or at www.solirisrems.com.

Soliris can cause serious side effects including:

  • Serious infusion-related reactions. Serious infusion-related reactions can happen during your Soliris infusion. Tell your doctor or nurse right away if you get any of these symptoms during your Soliris infusion:

If you have an infusion-relatedreaction to Soliris, your doctor may need to infuse Soliris more slowly, or stop Soliris. See “How will I receive Soliris?”

The most common side effects in people with PNH treated with Soliris include:

The most common side effects in people with aHUS treated with Soliris include:

The most common side effects in people with gMG treated with Soliris include:

  • muscle and joint (musculoskeletal) pain

The most common side effects in people with NMOSD treated with Soliris include:

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 Soliris. 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.

What is the dosage for Soliris?

Recommended Vaccination And Prophylaxis

  • Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection.
  • Provide two weeks of antibacterial drug prophylaxis to patients if Soliris must be initiated immediately and vaccines are administered less than two weeks before starting Soliris therapy.
  • Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS.

Recommended Dosage Regimen — PNH

For patients 18 years of age and older, Soliris therapy consists of:

  • 600 mg weekly for the first 4 weeks, followed by
  • 900 mg for the fifth dose 1 week later, then
  • 900 mg every 2 weeks thereafter. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

Recommended Dosage Regimen — aHUS

For patients 18 years of age and older, Soliris therapy consists of:

  • 900 mg weekly for the first 4 weeks, followed by
  • 1200 mg for the fifth dose 1 week later, then
  • 1200 mg every 2 weeks thereafter.

For patients less than 18 years of age, administer Soliris based upon body weight, according to the following schedule (Table 1)

Table 1: Dosing Recommendations in aHUS Patients Less Than 18 Years of Age

Patient Body Weight Induction Maintenance
40 kg and over 900 mg weekly x 4 doses 1200 mg at week 5; then 1200 mg every 2 weeks
30 kg to less than 40 kg 600 mg weekly x 2 doses 900 mg at week 3; then 900 mg every 2 weeks
20 kg to less than 30 kg 600 mg weekly x 2 doses 600 mg at week 3; then 600 mg every 2 weeks
10 kg to less than 20 kg 600 mg weekly x 1 dose 300 mg at week 2; then 300 mg every 2 weeks
5 kg to less than 10 kg 300 mg weekly x 1 dose 300 mg at week 2; then 300 mg every 3 weeks

Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

Recommended Dosage Regimen — gMG And NMOSD

For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of:

  • 900 mg weekly for the first 4 weeks, followed by
  • 1200 mg for the fifth dose 1 week later, then
  • 1200 mg every 2 weeks thereafter.

Administer Soliris at the recommended dosage regimen time points, or within two days of these time points.

Dose Adjustment In Case Of Plasmapheresis, Plasma Exchange, Or Fresh Frozen Plasma Infusion

For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2).

Table 2: Supplemental Dose of Soliris after PE/PI

Type of Plasma Intervention Most Recent Soliris Dose Supplemental Soliris Dose with Each Plasma Intervention Timing of Supplemental Soliris Dose
Plasmapheresis or plasma exchange 300 mg 300 mg per each plasmapheresis or plasma exchange session Within 60 minutes after each plasmapheresis or plasma exchange
≥600 mg 600 mg per each plasmapheresis or plasma exchange session
Fresh frozen plasma infusion ≥300 mg 300 mg per infusion of fresh frozen plasma 60 minutes prior to each infusion of fresh frozen plasma

SLIDESHOW

Anemia: Common Causes, Symptoms, Types, and Treatment See Slideshow

What drugs interact with Soliris?

No information provided

Is Soliris safe to use while pregnant or breastfeeding?

  • Limited data on outcomes of pregnancies that have occurred following Soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see Data).
  • There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy.
  • Although limited published data does not report detectable levels of eculizumab in human milk, maternal IgG is known to be present in human milk.
  • Available information is insufficient to inform the effect of eculizumab on the breastfed infant. There are no data on the effects of eculizumab on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.

Summary

Soliris (eculizumab) is a prescription medicine called a monoclonal antibody. Soliris is used to treat Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Serious side effects of Soliris include life-threatening and fatal meningococcal infections and serious infusion-related reactions.

Treatment & Diagnosis

QUESTION

Sickle cell disease is named after a farming tool. See Answer

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Medically Reviewed on 3/29/2021
References
All sections courtesy of the U.S. Food and Drug Administration