Soliris is a brand-name injection that’s prescribed for certain rare autoimmune conditions. Soliris contains the active ingredient eculizumab and belongs to the complement inhibitors drug class.
Autoimmune conditions occur when your immune system (your body’s defense system) mistakenly attacks tissues in your body. Soliris is FDA approved to treat the following autoimmune conditions in adults:
- paroxysmal nocturnal hemoglobinuria (PNH), which affects your red blood cells
- atypical hemolytic uremic syndrome (aHUS), which affects your blood vessels and kidneys
- generalized myasthenia gravis (gMG), which affects your muscles
- neuromyelitis optica spectrum disorder (NMOSD), which affects your spinal cord and optic nerves
Soliris is also FDA approved to treat aHUS in children ages 2 months and older.
For more information about these conditions, see the “Soliris uses” section below.
Drug details
You’ll find key information about Soliris below.
- Drug form: solution in a single-dose vial that’s given by intravenous (IV) infusion
- Generic or biosimilar available? no
- Prescription required? yes
- Controlled substance? no
- Year of FDA approval: 2007
Soliris has a boxed warning about the risk of serious meningococcal infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Soliris precautions” section below.
Soliris is a biologic drug that’s available only as a brand-name medication. It’s not currently available in a generic or biosimilar form.
Biologic drugs are made using living cells. It’s not possible to copy these drugs exactly. A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active ingredient in a brand-name medication.
Biosimilars are considered to be just as safe and effective as their parent drug. And like generics, biosimilars tend to cost less than brand-name medications.
Here are answers to some frequently asked questions about Soliris.
How does Soliris compare with Empaveli (pegcetacoplan)?
Soliris and Empaveli are both treatments for paroxysmal nocturnal hemoglobinuria (PNH). This condition is caused by your immune system (your body’s defense system) attacking your red blood cells. Soliris is also used to treat certain other conditions.
Both of these drugs work by reducing activity in part of your immune system called the complement system (a series of proteins). Soliris blocks a protein in the complement system called C5, while Empaveli blocks a different protein called C3.
These drugs can cause some similar and some different side effects. For example, both drugs can raise your risk of infections, especially serious meningococcal infections. Soliris and Empaveli both have a boxed warning about this side effect. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug side effects that can be dangerous.
Additionally, both drugs come as an injection. Soliris is taken by intravenous (IV) infusion, while Empaveli is taken by subcutaneous infusion. Soliris is typically taken once every 2 weeks, while Empaveli is typically taken twice per week.
To learn more about Soliris versus Empaveli, including how the dosages of these drugs compare, talk with your doctor.
How does Soliris compare with Ultomiris (ravulizumab-cwvz)?
Soliris and Ultomiris are both used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These conditions are caused by overactivity in your immune system (your body’s defense system). Soliris is also used to treat certain other conditions.
Soliris and Ultomiris both work in the same way. They reduce activity in part of your immune system called the complement system. Both drugs block a protein in the complement system called C5.
These drugs can cause similar side effects, including a raised risk of serious meningococcal infections. Both drugs have a boxed warning about this side effect. A boxed warning is the most serious warning from the FDA about drug side effects that can be dangerous.
Soliris and Ultomiris are both administered by intravenous (IV) infusion. Soliris is usually given once every 2 weeks, while Ultomiris is a longer-acting drug and is usually given once every 4 to 8 weeks.
To find out more about how Soliris compares with Ultomiris, talk with your doctor.
Soliris can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Soliris. These lists do not include all possible side effects.
For more information about the possible side effects of Soliris, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.
Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Soliris, you can do so through MedWatch.
Mild side effects
Below is a partial list of mild side effects of Soliris. Side effects may differ slightly between people depending on the condition Soliris is used to treat. To learn about other mild side effects, talk with your doctor or pharmacist, or view Soliris’s prescribing information.
Mild side effects of Soliris can include:
- headache
- sore throat
- respiratory infections, such as the common cold or flu
- other infections, such as urinary tract infections or cold sores
- muscle, joint, or back pain
- nausea and vomiting
- diarrhea
- abdominal pain
- dizziness
- mild high blood pressure
- swelling of the lower legs or feet due to fluid buildup
- fever
Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.
Serious side effects
Serious side effects from Soliris may occur. In the clinical studies, 60% of patients experienced a serious side effect. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.
Serious side effects and their symptoms can include:
- infusion-related reactions, which may cause symptoms such as:
- shortness of breath
- chest pain
- lightheadedness or fainting
- swelling of your face, tongue, or throat
- increased risk of serious infections, including pneumonia and gonorrhea, which may cause symptoms such as:
- fever
- cough
- shortness of breath
- burning pain when urinating
- green, white, or yellow discharge from the genitals
- worsening kidney function, which may cause symptoms such as:
- fatigue
- swelling of the hands, legs, or feet
- urine changes, such as urinating more often or blood in the urine
- severe high blood pressure
- increased risk of serious meningococcal infections*
* Soliris has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Soliris precautions” section below.
ALLERGIC REACTIONFor some people, Soliris infusion can cause an allergic reaction.
In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.
Ways to manage
A healthcare professional will monitor you for allergic reactions during your Soliris infusion and for at least 1 hour after the infusion is finished.
For mild allergic reaction symptoms, such as a mild rash, your healthcare professional may give you treatments to help manage your symptoms. They may also slow down or pause your infusion. If you have a mild allergic reaction, your doctor will let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, your healthcare professional will give immediate medical care. These symptoms can become life threatening if not treated right away. If you’ve had a serious allergic reaction to Soliris infusion, your doctor may recommend taking a different medication instead.
The Soliris dosage your doctor prescribes will depend on several factors. These include:
- the condition you’re using Soliris to treat
- your age
- other medical conditions you may have
The following information describes Soliris dosing schedules that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
Drug forms and strengths
Soliris comes as a liquid solution inside single-dose vials. Each vial contains 300 milligrams in 30 milliliters of solution (mg/mL). The solution has to be diluted to 5 mg/ml and allowed to come to room temperature prior to administration.
A healthcare professional will administer Soliris by intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time.
For adults, Soliris infusions are typically given over 35 minutes. For children, the infusions may be given over 1 to 4 hours.
Most people receive their Soliris infusions in a hospital or infusion center. But in some cases, it may be possible to receive the infusions at home.
Dosage for paroxysmal nocturnal hemoglobinuria
The usual recommended dosing schedule for adults with paroxysmal nocturnal hemoglobinuria (PNH) is as follows:
- weeks 1 to 4: 600 mg once a week
- week 5 and onward: 900 mg every 2 weeks
Dosage for atypical hemolytic uremic syndrome
The usual recommended dosing schedule for adults ages 18 years and older with atypical hemolytic uremic syndrome (aHUS) is as follows:
- weeks 1 to 4: 900 mg once a week
- week 5 and onwards: 1,200 mg every 2 weeks
Dosage for generalized myasthenia gravis
The usual recommended dosing schedule for adults with generalized myasthenia gravis (gMG) is as follows:
- weeks 1 to 4: 900 mg once a week
- week 5 and onward: 1,200 mg every 2 weeks
Dosage for neuromyelitis optica spectrum disorder
The usual recommended dosing schedule for adults with neuromyelitis optica spectrum disorder (NMOSD) is as follows:
- weeks 1 to 4: 900 mg once a week
- week 5 and onward: 1,200 mg every 2 weeks
Children’s dosage
Soliris is used to treat aHUS in children ages 2 to 17 years. The recommended dosage depends on the child’s body weight in kilograms (kg). One kg is approximately 2.2 pounds (lb). Usual dosages are described below:
Body weight | Recommended dosage |
---|---|
5 kg to less than 10 kg | week 1: 300 mg week 2 and onward: 300 mg every 3 weeks |
10 kg to less than 20kg | week 1: 600 mg week 2 and onward: 300 mg every 2 weeks |
20 kg to less than 30 kg | weeks 1 and 2: 600 mg once a week week 3 and onward: 600 mg every 2 weeks |
30 kg to less than 40 kg | weeks 1 and 2: 600 mg once a week week 3 and onward: 900 mg every 2 weeks |
40 kg and over | weeks 1 to 4: 900 mg once a week week 5 and onward: 1,200 mg every 2 weeks |
About taking Soliris
Below you’ll find information about key dosage issues.
- If you miss a dose: If you miss an appointment to have your dose of Soliris, call your doctor right away to reschedule.
- Length of use: Soliris is meant to be used as a long-term treatment. If you and your doctor determine that Soliris is safe and effective for you, you’ll likely take it long term.
- Length of time to work: Soliris starts working as soon as you receive your first dose. However, you may not notice it working. It may take a few weeks for your symptoms to improve.
The Food and Drug Administration (FDA) approves prescription drugs such as Soliris to treat certain conditions.
Soliris for paroxysmal nocturnal hemoglobinuria
Soliris is FDA approved to treat a rare condition called paroxysmal nocturnal hemoglobinuria (PNH) in adults.
With PNH, your immune system attacks and destroys red blood cells. This can cause the following problems and symptoms:
- anemia (low red blood cell count), which can make your skin, gums, or nailbeds look paler than usual and cause shortness of breath, fatigue, fast heartbeat, headaches, and chest pain
- hemoglobinuria, which occurs when hemoglobin (the red oxygen-transporting pigment in red blood cells) leaves your body in your urine, making your urine red or dark in color
- blood clots that can block blood flow to vital organs, especially your brain, liver, stomach, or intestines, causing symptoms such as headaches, trouble thinking, or abdominal pain
- thrombocytopenia (low platelet count), which can cause unusual red spots, bruising, or bleeding
- low white blood cell counts, which can cause frequent infections
Soliris treats PNH and its symptoms by helping stop your immune system from destroying your red blood cells.
Soliris for atypical hemolytic uremic syndrome
Soliris is FDA approved to treat a rare condition called atypical hemolytic uremic syndrome (aHUS) in adults and children ages 2 months and older.
With aHUS, your immune system attacks and damages small blood vessels in your body, especially those in your kidneys. This can cause blood clots in your blood vessels, which can block blood flow to vital organs such as the kidneys. As a result of all the clotting, your platelet level (cells that help blood clot) decreases. Also, your red blood cells can be destroyed as they pass through damaged blood vessels. These issues can cause the following problems and symptoms:
- kidney failure, which can cause reduced urination, swelling due to fluid buildup, confusion, and itching
- thrombocytopenia (low platelet count), which can cause unusual red spots, bruising, or bleeding
- anemia (low red blood cell count), which can make your skin, gums, or nailbeds look paler than usual and cause shortness of breath and fatigue
Soliris treats aHUS and its symptoms by helping to stop your immune system attacking your blood vessels.
Soliris for generalized myasthenia gravis
Soliris is FDA approved to treat generalized myasthenia gravis (gMG) in certain adults.
With gMG, your immune system attacks and destroys acetylcholine receptors on your muscles. These receptors are special sites that allow your nerves to communicate with your muscles. gMG causes muscle weakness throughout your body.
Symptoms of gMG can include:
- fatigue
- eye muscle weakness
- blurry or double vision
- drooping of one or both eyelids
- neck and limb weakness
- trouble smiling or speaking
- trouble chewing or swallowing
- trouble breathing
Soliris is specifically approved for people with gMG who have antibodies against acetylcholine receptors (AchR). The medication helps stop your immune system from attacking the acetylcholine receptors on your muscles.
Soliris for neuromyelitis optica spectrum disorder
Soliris is FDA approved to treat a rare condition called neuromyelitis optica spectrum disorder (NMOSD) in certain adults.
With NMOSD, your immune system attacks and damages your optic nerves and spinal cord. The condition can cause symptoms such as:
- eye pain
- blurry, dim, or faded vision
- numbness, tingling, or shooting pain
- muscle weakness or stiffness
- loss of bladder or bowel control
- uncontrollable nausea, vomiting, or hiccups
- confusion
- seizures
Soliris is specifically approved for people with NMOSD who have antibodies against a protein called aquaporin-4 (AQP4). The medication helps stop your immune system from attacking your optic nerves and spinal cord.
Soliris and children
Soliris is FDA approved to treat aHUS in children ages 2 months to 17 years. For more information, see the “Soliris dosage” section above.
Soliris is not approved for any other uses in children.
Alcohol interaction
Alcohol is not known to interact with Soliris. However, alcohol and Soliris can cause some similar side effects, such as headache, nausea, vomiting, and dizziness. Drinking alcohol during Soliris treatment may worsen these side effects or make them more likely to occur.
If you have questions about how much alcohol is safe to drink while taking Soliris, talk with your doctor or pharmacist.
Interactions with medications, foods, and supplements
Soliris is not known to interact with other medications, herbs, supplements, or foods. The manufacturer did not list any interactions in the drug’s prescribing information.
However, this doesn’t mean that interactions won’t be recognized in the future. For example, new drugs could be approved that interact with Soliris.
Before starting Soliris treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.
As with all medications, the cost of Soliris infusion can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.
Financial and insurance assistance: If you need financial support to pay for Soliris, or if you need help understanding your insurance coverage, help is available.
A program called OneSource is available for Soliris. For more information and to find out if you’re eligible for support, call 888-765-4747 or visit the program website.
To learn more about saving money on prescriptions, check out this article.
Generic or biosimilar version: Soliris is a biologic drug that’s available only as a brand-name medication. It’s not currently available in generic or biosimilar form.
Biologic drugs are made using living cells. It’s not possible to copy these drugs exactly. A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug). A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active ingredient in a brand-name medication. Like generics, biosimilars tend to cost less than brand-name medications.
To learn more about saving money on prescriptions, check out this article.
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Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Soliris, talk with your doctor. They can tell you about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.
Examples of other drugs doctors may prescribe to treat paroxysmal nocturnal hemoglobinuria (PNH) include:
- epoetin alfa (Epogen, Procrit)
- darbepoetin alfa (Aranesp)
- pegcetacoplan (Empaveli)
- ravulizumab-cwvz (Ultomiris)
Examples of other drugs doctors may prescribe to treat atypical hemolytic uremic syndrome (aHUS) include:
- ravulizumab-cwvz (Ultomiris)
Examples of other drugs doctors may prescribe to treat generalized myasthenia gravis (gMG) include:
- ravulizumab (Ultomiris)
- zilucoplan (Zilbrysq)
- efgartigimod (Vyvgart, Vyvgart Hytrulo)
- rozanoxilixizumab (Rystiggo)
Examples of other drugs doctors may prescribe to treat neuromyelitis optica spectrum disorder (NMOSD) include:
- inebilizumab (Uplizna)
- mycophenolate mofetil (Cellcept)
- prednisone (Rayos)
- rituximab (Rituxan, others)
- satralizumab-mwge (Enspryng)
If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.
Soliris and pregnancy
It’s not known whether Soliris should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.
Soliris and birth control
It’s not known if Soliris is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Soliris.
Soliris and breastfeeding
It’s not known whether Soliris should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.
This drug comes with several precautions.
FDA warning: serious meningococcal infections
This drug has a boxed warning. This is a serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
Serious meningococcal infections: Soliris weakens part of your immune system and can raise your risk of serious and life threatening infections caused by Neisseria meningitidis bacteria. These include meningitis and septicemia (blood infection).
Due to the risk of serious meningococcal infections, Soliris is only available through a drug safety program called the Soliris Risk Evaluation and Mitigation Strategy (REMS) program. As part of this program, your doctor will make sure that you are up to date with recommended meningococcal vaccines before you start Soliris treatment.
If you need a meningococcal A, C, W, Y, or B vaccine, you should usually receive this at least 2 weeks before starting Soliris. If your doctor recommends starting Soliris sooner than this, they will likely prescribe antibiotics to help prevent meningococcal infections until the vaccines have time to work.
Vaccination reduces your risk of meningococcal infections, but it’s still possible to get these infections while receiving Soliris and for several weeks after stopping treatment. Be sure to see your doctor right away if you develop symptoms of meningococcal infections during or after your treatment. But if your symptoms feel life threatening, call 911 or your local emergency number right away.
Symptoms of meningococcal infections can include:
- headache with fever, nausea, vomiting, stiff neck, or stiff back
- skin rash that does not fade when pressed
- fever with or without a skin rash
- sensitivity to light
- flu-like symptoms with aching muscles or joints
- cold hands and feet
- sleepiness
- confusion
If you develop a meningococcal infection during Soliris treatment, your doctor will prescribe antibiotics to treat the infection. They may also pause your Soliris treatment until the infection gets better.
As part of the Soliris REMS, your doctor will give you a patient safety card that you should carry throughout your Soliris treatment and for 3 months after your last dose. If you receive treatment from any healthcare professional during this time, be sure to show them this card.
If you have questions or concerns about the risk of meningococcal infections with Soliris, talk with your doctor.
Other precautions
Before taking Soliris, discuss your health history with your doctor. Soliris may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- active, ongoing, or recurrent infections
- weak immune system
- low white blood cell count
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
Note: For more information about the potential negative effects of Soliris, see the “Soliris side effects” section above.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.