Generic Name: Eculizumab (e kue LIZ oo mab)
Brand Name: Soliris
- Very bad and sometimes deadly meningococcal infections have happened in patients who have taken this medicine (Soliris). This type of infection can happen right away and be deadly if not treated early. Get a meningococcal vaccine at least 2 weeks before starting this medicine unless your doctor tells you otherwise. Talk with your doctor.
- You may only get this medicine (Soliris) through a special program. Talk with your doctor.
Uses of Soliris:
- It is used to treat a blood disease called paroxysmal nocturnal hemoglobinuria (PNH).
- It is used to treat a blood and kidney disease called atypical hemolytic uremic syndrome (aHUS).
What do I need to tell my doctor BEFORE I take Soliris?
- If you have an allergy to eculizumab or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you did not get a meningococcal vaccine.
- If you have a meningococcal infection.
This is not a list of all drugs or health problems that interact with this medicine (Soliris).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Soliris?
- Tell all of your health care providers that you take this medicine (Soliris). This includes your doctors, nurses, pharmacists, and dentists.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- Make sure you are up to date with all your vaccines before treatment with this medicine.
- Vaccines lower the risk of infections; they do not get rid of the risk of infections. Talk with the doctor.
- Have patient safety card with you at all times and for 3 months after drug is stopped.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Some patients have very bad side effects during the infusion. Tell your doctor if you have any bad effects during the infusion.
- Some health problems may happen after this medicine (Soliris) is stopped. You will need to be watched closely for several weeks after you stop this medicine. Follow up with your doctor as you have been told. After stopping this medicine (Soliris), call your doctor right away if you have a change in how much urine is passed; dark urine; swelling, warmth, or pain in the leg or arm; chest pain or pressure; coughing up blood; trouble breathing; weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight; change in thinking clearly and with logic; any bruising or bleeding that is not normal; or seizures.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Soliris) best taken?
Use this medicine (Soliris) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of a meningococcal infection like very bad headache with or without upset stomach, throwing up, fever, or stiff neck or back; change in thinking clearly and with logic; high fever; fever with a rash; if light bothers the eyes; or very bad muscle aches or pain with or without flu-like signs.
- Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Chest pain.
- Not able to pass urine or change in how much urine is passed.
- A fast heartbeat.
- Very bad dizziness or passing out.
- Very bad headache.
- Swelling in the arms or legs.
- Feeling very tired or weak.
What are some other side effects of Soliris?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Nose and throat irritation.
- Runny nose.
- Back pain.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Feeling tired or weak.
- Belly pain.
- Not able to sleep.
- Hard stools (constipation).
- Muscle or joint pain.
- Pain in arms or legs.
- Muscle spasm.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Soliris?
- If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (Soliris) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine (Soliris) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine (Soliris). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: November 1, 2017
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- Drug class: selective immunosuppressants