Soliris (Intravenous)
Eculizumab is used in adults to treat myasthenia gravis or neuromyelitis optica spectrum disorder.
Eculizumab is also used to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria.
Eculizumab is used in adults and children weighing at least 11 pounds (5 kilograms) to treat a blood disease called atypical hemolytic uremic syndrome.
Eculizumab is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.
Eculizumab may also be used for purposes not listed in this medication guide.
uses
What is Soliris (Intravenous) used for?
- Neuritis
- Myasthenia Gravis
- Hemolytic Uremic Syndrome
- Paroxysmal Nocturnal Hemoglobinuria
warnings
What is the most important information I should know about Soliris (Intravenous)?
You should not receive eculizumab if:
- you have a meningococcal infection.
Tell your doctor if you have a fever or any type of infection.
Your doctor may recommend certain vaccines. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. If you were vaccinated in the past, you may need a booster dose.
Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Soliris (Intravenous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
Seek emergency medical attention if you have symptoms of meningitis:
- fever, headache or skin rash;
- headache with nausea and vomiting;
- body aches, flu symptoms;
- confusion, increased sensitivity to light; or
- stiffness in your neck or back.
During or after your treatment with eculizumab call your doctor at once if you have:
- fever;
- pain or burning when you urinate;
- dangerously high blood pressure--dizziness, weakness, numbness, confusion, blurred vision, vomiting, chest pain, cough, shortness of breath, seizure;
- kidney problems--swelling, urinating less, feeling tired or short of breath;
- 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
- signs of a blood clot--sudden numbness or weakness on one side of the body, chest pain, problems with vision or speech, pain or swelling in one leg.
Common side effects may include:
- headache, dizziness;
- flu symptoms (fever, tiredness, aches, cough, sore throat);
- runny or stuffy nose, sinus pain;
- painful urination;
- nausea, vomiting, diarrhea, stomach pain;
- swelling in your legs or feet;
- bruising;
- muscle or joint pain, back pain;
- anemia (low red blood cells); or
- high blood pressure.
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.
Pregnancy & Breastfeeding
Can I take Soliris (Intravenous) if I’m pregnant or breastfeeding?
Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Soliris (Intravenous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Soliris (Intravenous)?
Use Soliris (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor will perform tests to make sure eculizumab is the right treatment for you.
Eculizumab is injected into a vein by a healthcare provider. The infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children.
Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.
You may be given other medications to help prevent serious side effects or allergic reaction. Keep taking these medicines for as long as your doctor has prescribed.
You will be watched closely for at least 1 hour after each infusion, to make sure you do not have a reaction.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
You will receive a card listing the symptoms of meningococcal infection. Read this information and learn what symptoms to watch for. Keep the card with you at all times while using eculizumab and for at least 3 months after your last dose.
Do not stop receiving eculizumab without first talking to your doctor. Interrupting your treatment could cause sudden and serious effects on your red blood cells.
Eculizumab can effect your body for up to 3 months. You may need medical tests for 8 to 12 weeks if you stop using this medicine. Make sure any doctor who treats you knows that you've used eculizumab.
Call your doctor for instructions if you miss an appointment for your eculizumab injection.