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eculizumab

Pronunciation: E kue LIZ oo mab

Brand: Soliris

What is the most important information I should know about eculizumab?

You should not use this medicine if you have bacterial meningitis or if you have not been vaccinated against meningitis.

You must be vaccinated against meningococcal infection at least 2 weeks before treatment with eculizumab. 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 have symptoms of meningitis: headache and fever with nausea or vomiting, skin rash, body aches, flu symptoms, confusion, sensitivity to light, stiffness in your neck or back.

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. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

What is eculizumab?

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.

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

Eculizumab is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS)

Eculizumab is also used to treat myasthenia gravis in adults.

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.

What should I discuss with my health care provider before taking eculizumab?

You should not use eculizumab if you are allergic to it, or if:

  • you have bacterial meningitis; or
  • you have not been vaccinated against meningitis.

Tell your doctor if you have a fever or any type of infection.

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.

Your doctor may also recommend other vaccines while you are using eculizumab.

Follow your doctor's instructions about using this medicine if you are pregnant. It is very important to control your blood disorder during pregnancy to avoid unwanted effects in you or the baby.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

How is eculizumab given?

Eculizumab is given as an infusion into a vein. A healthcare provider will give you this injection. The infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children.

Eculizumab is not given every day. Follow your doctor's dosing instructions very carefully. The dosing schedule may be different for a child or teenager than for an adult.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on age and weight in children, and any changes may affect your child's dose.

You should be watched closely for at least 1 hour after each infusion, to make sure you do not have an allergic reaction.

Eculizumab affects your immune system. You may get infections more easily, even serious or fatal infections, during treatment and for up to 3 months after your last dose.

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 have long-lasting effects on your body (up to 3 months). You may need frequent medical tests for 8 to 12 weeks if you stop using this medicine for any reason. Make sure any doctor who treats you knows that you've used eculizumab.

What happens if I miss a dose?

Call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking eculizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of eculizumab?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. These symptoms may occur during the injection.

Seek emergency medical attention if you have symptoms of meningitis:

  • fever and a headache or skin rash;
  • headache with nausea and vomiting;
  • high fever (103 degrees F or higher), 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;
  • kidney problems --little or no urination, painful or difficult urination, swelling in your feet or ankles, 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, problems with speech or balance, rapid breathing, coughing up blood, pain or swelling in your arms or legs.

Common side effects may include:

  • headache;
  • nausea, vomiting, diarrhea, stomach pain;
  • swelling in your legs or feet;
  • cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat;
  • joint pain, back pain; or
  • increased blood pressure --severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety.

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.

What other drugs will affect eculizumab?

Other drugs may affect eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about eculizumab.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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