Soliris (eculizumab)

Soliris generic or biosimilar

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.

Common questions about Soliris

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 side effects

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 REACTION

For 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.

Soliris dosage

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:

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.

Soliris uses

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.

Soliris interactions

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.

Soliris cost and coupons

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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Alternative drugs

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)

Things to consider when taking Soliris

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.