Soliris (eculizumab) is a monoclonal antibody. Eculizumab binds to proteins in the blood that can destroy red blood cells in people with genetic conditions that affect the natural defenses of red blood cells.
Soliris is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).
Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS)
Soliris may also be used for purposes not listed in this medication guide.
Important information
Soliris is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).
You should not use this medication if you have bacterial meningitis or if you have not been vaccinated against meningitis. Tell your doctor if you have a fever or any type of infection.
Soliris affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with Soliris. Even if you have been vaccinated in the past, you may need a booster dose.
Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis: headache and fever with nausea or vomiting, high fever (103 degrees or higher), body aches, flu symptoms, confusion, increased sensitivity to light, stiffness in your neck or back.
With your medication you will receive a Soliris Patient Safety Information Card listing the symptoms of meningitis. Carry this card with you at all times.
Do not stop using Soliris without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.
Before taking this medicine
Soliris affects your immune system, and using this medication may increase your risk of serious infection such as meningitis.
You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with Soliris. Even if you have been vaccinated in the past, you may need a booster dose.
It is best to stay current on all of your vaccinations while you are using Soliris, and your doctor may recommend other vaccines before or during treatment.
Children being treated with Soliris may also need to be vaccinated against influenza or pneumonia before treatment begins.
You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.
To make sure you can safely use Soliris, tell your doctor if you have a fever or any type of infection.
FDA pregnancy category C. It is not known whether Soliris will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Soliris is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.
How is Soliris given?
Soliris is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Soliris is usually given once a week for 5 weeks, and then once every 2 weeks thereafter. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Soliris must be mixed in an IV bag with a liquid (diluent) before injecting it.
If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
To reduce discomfort from your injection, allow the mixed Soliris IV bag to reach room temperature before using, but never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.
You may have a reaction to the infusion (when the medicine is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, but the infusion should not take more than 2 hours to complete. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.
Each single-use vial (bottle) of Soliris is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Do not stop using Soliris without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.
If you stop using Soliris for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any scheduled visits to your doctor during this follow-up period.
Store unopened vials of Soliris in their original carton in the refrigerator. Protect from light and do not freeze. Throw away any unused vials after the expiration date on the label has passed.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of this medication.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Soliris side effects
Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis:
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headache and fever with nausea or vomiting;
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high fever (103 degrees or higher), body aches, flu symptoms;
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confusion, increased sensitivity to light; or
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stiffness in your neck or back.
With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times.
Get emergency medical help if you have any of these signs of an allergic reaction to Soliris: hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these side effects during or after your treatment with Soliris:
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pale or yellowed skin, dark colored urine, fever, confusion or weakness;
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feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
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easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
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pain or burning when you urinate;
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swelling, rapid weight gain, urinating less or not at all;
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sudden numbness or weakness, especially on one side of the body;
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sudden severe headache, problems with vision, speech, or balance;
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chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
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pain, swelling, warmth, or redness in one or both legs; or
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increased blood pressure (severe headache, blurred vision, buzzing in your ears, shortness of breath).
Common Soliris side effects may include:
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mild headache;
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nausea, vomiting, diarrhea;
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back pain; or
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cold symptoms such as stuffy nose, sneezing, sore throat.
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 FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Soliris?
Other drugs may interact with Soliris, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
