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:- chest pain
- trouble breathing or shortness of breath
- swelling of your face, tongue, or throat
- feel faint or pass out
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:
- headache
- diarrhea
- high blood pressure (hypertension)
- common cold (upper respiratory infection )
- stomach-area (abdominal pain)
- vomiting
- pain or swelling of your nose or throat (nasopharyngitis)
- low red blood cell count (anemia)
- cough
- swelling of legs or feet (peripheral edema )
- nausea
- urinary tract infections
- fever
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:
- common cold (upper respiratory infection)
- pain or swelling of your nose or throat (nasopharyngitis)
- diarrhea
- back pain
- joint pain (arthralgia)
- throat irritation (pharyngitis)
- bruising (contusion)
- dizziness
- flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches
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
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.