Generic Name: eculizumab (E-kue-LIZ-ue-mab)
Brand Name: Soliris
Soliris increases the risk of meningococcal infection (eg, meningitis, meningococcemia). This type of infection may rapidly become life-threatening or fatal if not recognized and treated early. If you have not already had a meningococcal vaccine, you must receive 1 at least 2 weeks before your first dose of Soliris. You must also be revaccinated according to current guidelines as long as you use Soliris. Check with your doctor for more information.
The vaccine may not prevent meningococcal infection in all cases. Contact your doctor right away if you develop early signs of meningococcal infection. These symptoms include moderate to severe headache along with nausea, vomiting, fever, stiff neck or back; confusion; high fever (higher than 103 degrees F); fever with a rash; eyes sensitive to light; or severe muscle aches with flu-like symptoms.
Soliris is used for:
Treating a certain type of blood disorder called paroxysmal nocturnal hemoglobinuria (PNH). It may also be used to treat a condition called atypical hemolytic uremic syndrome (aHUS). It may also be used for other conditions as determined by your doctor.
Soliris is a monoclonal antibody. It works by blocking part of the immune system. This helps to reduce symptoms of PNH and aHUS.
Do NOT use Soliris if:
- you are allergic to any ingredient in Soliris
- you have a meningococcal infection
- you are not vaccinated against meningococcal infection, unless your doctor tells you otherwise
Contact your doctor or health care provider right away if any of these apply to you.
Before using Soliris:
Some medical conditions may interact with Soliris. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including mouse or murine proteins
- if you have an infection, a fever, a weak immune system, or low white blood cell levels
Some MEDICINES MAY INTERACT with Soliris. However, no specific interactions with Soliris are known at this time.
Ask your health care provider if Soliris may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Soliris:
Use Soliris as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Soliris comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soliris refilled.
- Be sure you receive the Patient Safety Card that comes with Soliris. Carry it with you at all times while using Soliris and for 3 months after your last dose. This card lists the symptoms of meningococcal infection and what to do if you have them. Seek medical help right away if you develop any symptoms on the card.
- If you have not already had a meningococcal vaccine, you must receive 1 at least 2 weeks before you start Soliris. If you have had this vaccination in the past, you might need a booster dose before starting Soliris. Check with your doctor.
- Soliris is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
- Do not use Soliris if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not shake Soliris.
- Do not stop using Soliris without checking with your doctor. If you need to stop Soliris, your doctor will need to monitor your condition closely for at least 8 to 12 weeks after you stop using it.
- If you miss a dose of Soliris, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Soliris.
Important safety information:
- Soliris may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.
- Soliris increases the risk of meningococcal infection. Contact your doctor right away if you develop signs of meningococcal infection, even if you have had a meningococcal vaccine. Meningococcal infection may rapidly become life-threatening or fatal if not recognized and treated early. Symptoms of meningococcal infection include moderate to severe headache along with nausea, vomiting, fever, stiff neck or back; confusion; high fever (higher than 103 degrees F); fever with a rash; eyes sensitive to light; or severe muscle aches with flu-like symptoms.
- Before you use Soliris, discuss your vaccination history with your doctor. You must be up-to-date on your vaccines before you start Soliris.
- Infusion-related reactions may occur with the use of Soliris. Your health care provider will monitor you for a reaction while you receive Soliris and for at least 1 hour after you receive it. Contact your doctor right away if you experience chest pain; fainting; trouble breathing or shortness of breath; or swelling of the face, tongue, or throat.
- Tell your doctor or dentist that you take Soliris before you receive any medical or dental care, emergency care, or surgery.
- Stopping treatment with Soliris may cause an increased risk of certain serious conditions. Your doctor will monitor you closely for at least 8 to 12 weeks after you stop Soliris. Discuss any questions or concerns with your doctor. Contact your doctor right away if you have stopped Soliris and you develop a change in the amount of urine produced; calf or leg pain, redness, warmth, or tenderness; swelling in the arms or legs; chest pain; coughing up blood; trouble breathing; confusion; one-sided weakness; vision changes or slurred speech; or seizures.
- Lab tests, including complete blood cell counts, hemoglobin levels, serum creatinine, and serum lactate dehydrogenase (LDH), may be performed while you use Soliris and for a period of time after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Soliris should be used with extreme caution in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Soliris while you are pregnant. It is not known if Soliris is found in breast milk. If you are or will be breast-feeding while you use Soliris, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Soliris:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; mild cough; mild headache; nausea; nose, throat, or sinus irritation; stomach pain; stuffy nose; tiredness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling mouth, face, lips, or tongue); change in how much urine is produced; difficult or painful urination; fast heartbeat; fever or chills; light-headedness; persistent cough or sore throat; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet; unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Soliris:
Soliris is usually handled and stored by a health care provider. If you are using Soliris at home, store Soliris as directed by your pharmacist or health care provider. Keep Soliris out of the reach of children and away from pets.
- If you have any questions about Soliris, please talk with your doctor, pharmacist, or other health care provider.
- Soliris is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Soliris or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 Soliris. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Soliris. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Soliris.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.