Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects the natural defenses of red blood cells.

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic (HEEM-oh-LIT-ik yoo-REEM-ik) uremic syndrome.

Eculizumab may also be used for purposes not listed in this medication guide.

Do not shake the eculizumab vial (bottle) or you may ruin the medicine.

Eculizumab 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 eculizumab. If you have been vaccinated in the past, you may need a booster dose. Call your doctor at once if you have a serious side effect such as severe headache, high fever, chills, stiffness in your neck or back, confusion, sensitivity to bright light, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions). With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

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.

Before using eculizumab, tell your doctor if you have a fever or any type of infection.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

Eculizumab 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.

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a high fever (103 degrees or higher), chills, body aches, and other flu-like symptoms.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. 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 eculizumab, and your doctor may recommend other vaccines before or during treatment.

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.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

Eculizumab 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.

To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.