Soliris
Pronunciation: so-leer-is
Generic name: eculizumab
Dosage form: injection for intravenous infusion
Drug class: Selective immunosuppressants
What is Soliris?
Soliris (eculizumab) is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults, and a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms).
- Soliris should not be used to treat aHUS in people with Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).
Soliris is also used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AchR) antibody positive, as well as neuromyelitis optica spectrum disorder (NMOSD) in adults.
Soliris's mechanism of action involves binding to a specific protein called complement protein C5 in the blood, preventing it from breaking apart into other proteins that can destroy red blood cells. Soliris is used to treat people with genetic conditions that affect the natural defenses of their red blood cells (see How does Soliris work for PNH? for more information).
Soliris infusion gained FDA approval on March 16, 2007, for PNH. Other approvals for Soliris followed (aHUS, 2011; gMG, 2017; NMOSD, 2019).
Soliris is available as an interchangeable biosimilar called Bkemv, which can be substituted for Soliris at the pharmacy level; and as a biosimilar called Epysqli, which can be substituted for Soliris at the prescriber level.
Ultomiris is a longer-acting monoclonal antibody also made by Alexion Pharmaceuticals that may be used to treat PNH, aHUS, gMG, and NMOSD (see How does Ultomiris compare to Soliris for PNH?).
Soliris REMS
Soliris infusion is available only under a special program called the Ultomiris and Soliris Risk Evaluation and Mitigation Strategy (REMS). Before you can receive Soliris, your healthcare provider must:
- enroll in the Ultomiris and Soliris REMS program
- counsel you about the risk of serious meningococcal infections
- give you information about the signs and symptoms of serious meningococcal infection
- make sure that you are vaccinated against serious infections caused by meningococcal bacteria and that you receive antibiotics if you need to start Soliris right away and you are not up to date on your vaccines give you a Patient Safety Card about your risk of meningococcal infection, as discussed above.
Soliris side effects
The most common side effects of Soliris are:
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headache, dizziness;
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flu symptoms (fever, tiredness, aches, cough, sore throat);
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runny or stuffy nose, sinus pain;
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painful urination or urinary tract infections;
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nausea, vomiting, diarrhea, stomach pain;
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swelling in your legs or feet;
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bruising;
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muscle or joint pain, back pain;
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a blood cell disorder; or
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high blood pressure.
Serious side effects and warnings
Soliris carries a Boxed Warning for serious meningococcal infections.
Meningococcal infections. Soliris increases the risk of serious and life-threatening infections caused by meningococcal bacteria (Neisseria meningitidis). Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early.
- You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first Soliris infusion.
- If you have not completed your meningococcal vaccines and Soliris must be started right away, you should receive the required vaccine(s) as soon as possible.
- If you have not been vaccinated and Soliris must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
- If you had a meningococcal vaccine in the past, you might need additional vaccines before starting Soliris. Your healthcare provider will decide if you need additional meningococcal vaccines.
- Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection:
- fever
- fever with a high heart rate
- headache and fever
- confusion
- muscle aches with flu-like symptoms
- fever and a rash
- headache with nausea or vomiting
- headache with a stiff neck or stiff back
- eyes sensitive to light.
Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of Soliris. Your risk of
meningococcal infection may continue for several weeks after your last dose. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.
Soliris may also increase the risk of other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.
- If your child is treated with Soliris, your child should receive vaccines against S. pneumoniae and H. influenzae type b (Hib).
- Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
- Certain fungal infections (aspergillus) may also happen if you take Soliris and have a weak immune system or a low white blood cell count.
Serious infusion-related reactions. Serious infusion-related reactions can happen during your Soliris infusion. Tell your healthcare provider or nurse right away if you get any of these symptoms during your 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-related reaction to Soliris, your healthcare provider may need to infuse it more slowly, or stop Soliris.
Soliris affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have a headache and fever with nausea or vomiting, skin rash, body aches, flu symptoms, confusion, sensitivity to light, or stiffness in your neck or back.
Do not stop receiving Soliris without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.
Get emergency medical help if you have signs of an allergic reaction to Soliris such as hives; chest pain, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. These symptoms may occur during the injection.
During or after your treatment with Soliris call your doctor at once if you have:
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fever;
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pain or burning when you urinate;
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dangerously high blood pressure - dizziness, weakness, numbness, confusion, blurred vision, vomiting, chest pain, cough, shortness of breath, seizure;
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kidney problems - swelling, urinating less, feeling tired or short of breath;
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signs of a blood cell disorder - pale skin, unusual tiredness, feeling light-headed, cold hands and feet, easy bruising, unusual bleeding, confusion, chest pain, trouble breathing, seizure (convulsions); or
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signs of a blood clot - sudden numbness or weakness, problems with speech or balance, rapid breathing, coughing up blood, pain or swelling in your arms or legs.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking this medicine
You should not use Soliris if:
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you have a fever or any type of infection
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you have not been vaccinated against meningitis
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you are pregnant or intending to become pregnant
- you are breastfeeding or intending to breastfeed.
Your doctor may recommend certain vaccines. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with Soliris. If you were vaccinated in the past, you may need a booster dose.
Pregnancy
It is not known if Soliris will harm an unborn baby. Follow your doctor's instructions about using this medicine if you are pregnant. It is very important to control your blood disorder during pregnancy to avoid unwanted effects in you or the baby.
Breastfeeding
Ask a doctor if it is safe to breastfeed while using Soliris.
How is Soliris administered?
Soliris is injected into a vein by a healthcare provider. The infusion can take at least 35 minutes to complete in adults, or 1 to 4 hours in children.
Adults will usually receive a Soliris infusion:
- weekly for 5 weeks, then
- every 2 weeks.
Children less than 18 years of age, your healthcare provider will decide how often you will receive Soliris depending on your age and body weight.
After each infusion, you should be monitored for at least 1 hour for infusion-related reactions.
If you have an infusion-related reaction during your Soliris infusion, your healthcare provider may decide to give Soliris more slowly or stop your infusion.
- If you miss a Soliris infusion, call your healthcare provider right away.
If you have PNH, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping Soliris. Stopping treatment with Soliris may cause a breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:
- drop in the number of your red blood
- cell count
- kidney problems
- drop in your platelet
- counts
- blood clots
- confusion
- difficulty breathing
- chest pain.
If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 weeks after stopping Soliris for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy).
Symptoms or problems that can happen with abnormal clotting may include:
- stroke
- difficulty breathing
- confusion
- kidney problems
- seizure
- swelling in arms or legs
- chest pain (angina)
- a drop in your platelet count.
Your doctor will perform tests to make sure Soliris is the right treatment for you.
Do not stop receiving Soliris without first talking to your doctor. Interrupting your treatment could cause sudden and serious effects on your red blood cells.
Soliris dosing
Usual Adult Soliris Dose for Paroxysmal Nocturnal Hemoglobinuria:
- Soliris 600 mg IV every week for 4 weeks, followed by 900 mg IV at week 5, then 900 mg IV every 2 weeks
Usual Adult Soliris Dose for Hemolytic Uremic Syndrome:
- Soliris 900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks
Usual Adult Soliris Dose for Myasthenia Gravis:
- Soliris 900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks
Usual Adult Soliris Dose for Neuritis:
- Soliris 00 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks
Usual Child Soliris Dose for Atypical Hemolytic Uremic Syndrome (aHUS):
2 months and older:
-Weight 5 kg to less than 10 kg: Soliris 300 mg IV for the first dose, followed by 300 mg IV at week 2, then 300 mg IV every 3 weeks
-Weight 10 kg to less than 20 kg: Soliris 600 mg IV for the first dose, followed by 300 mg IV at week 2, then 300 mg IV every 2 weeks
-Weight 20 kg to less than 30 kg: Soliris 600 mg IV every week for the first 2 doses, followed by 600 mg IV at week 3, then 600 mg IV every 2 weeks
-Weight 30 kg to less than 40 kg: Soliris 600 mg IV every week for the first 2 doses, followed by 900 mg IV at week 3, then 900 mg IV every 2 weeks
-Weight 40 kg or greater: Soliris 900 mg IV every week for the first 4 doses, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks
Related/similar drugs
Empaveli, Vyvgart, Zilbrysq, pyridostigmine, Mestinon, neostigmine, eculizumab, Ultomiris, ravulizumab, Fabhalta
What happens if I miss a dose?
Call your doctor for instructions.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Soliris?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Soliris?
Other drugs may interact with eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Soliris ingredients
Active ingredient: eculizumab
Inactive ingredients: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, and Water for Injection
Who makes Soliris?
Alexion Pharmaceuticals, Inc. manufactures Soliris.
Soliris Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Soliris.
Soliris (eculizumab) - Alexion Pharmaceuticals, Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 300 mg/30 mL (10 mg/mL) |
Soliris interchangeable products
Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.
Pharmacy laws for biosimilar prescribing may vary by state.
Bkemv (eculizumab-aeeb) - Amgen Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 300 mg/30 mL (10 mg/mL) |
View Bkemv information in detail.
Soliris biosimilar products
Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.
Pharmacy laws for biosimilar prescribing may vary by state
Epysqli (eculizumab-aagh) - Samsung Bioepis Co., Ltd.
Formulation type | Strength |
---|---|
Single-Dose Vial | 300 mg/30 mL (10 mg/mL) |
View Epysqli information in detail.
Popular FAQ
Can Soliris be administered at home?
Yes, a visiting nurse may come to your house to administer Soliris or it may be given at a special infusion center. Soliris is given as an intravenous (IV) infusion into your vein. Your location and insurance type can affect where you will receive Soliris.
How does Ultomiris compare to Soliris for PNH?
Ultomiris (ravulizumab) and Soliris (eculizumab) are both C5 complement inhibitors approved to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a blood disease caused by red blood cell destruction. Ultomiris has a longer half-life, meaning it stays in your blood longer and does not have to be dosed as often. Continue reading
How does Soliris work for PNH?
Soliris works by binding to the complement protein C5. This helps stop the activation of C5a / C5b and prevents formation of terminal complement complex C5b-9. Clinically, Soliris helps to stop red blood cell destruction and symptoms like anemia, fatigue and blood clots in patients living with paroxysmal nocturnal hemoglobinuria (PNH). Continue reading
How does Empaveli compare to Soliris?
Empaveli is a brand name for pegcetacoplan which is a PEGylated 40kDa polyethylene glycol linear small molecule that acts as a C3 complement inhibitor and Soliris is a brand name for eculizumab which is a monoclonal antibody that specifically binds to the complement protein C5. Empaveli is given by subcutaneous infusion and people can be taught how to self-administer it at home. Soliris is given by infusion under the guidance of a healthcare professional every 2 weeks (after the initial dosing schedule) although most patients are encouraged to switch from Soliris to Ultomaris which only requires 7 infusions in adults a year. Continue reading
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