eculizumab

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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. Using eculizumab can increase your risk of getting 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, to carry with you at all times. During treatment with eculizumab and for at least 3 months after your last dose, make sure any doctor who treats you knows that you are using this medicine.

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.

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 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 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.

Eculizumab affects your immune system. Using this medicine can increase your risk of serious infection such as meningitis, both during treatment and for up to 3 months after you stop using eculizumab.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster dose. However, a meningococcal vaccine may not prevent meningitis in every person.

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.

Children being treated with eculizumab may also need to be vaccinated against influenza or pneumonia before treatment begins.

To make sure eculizumab is safe for you, tell your doctor if you have a fever or any type of infection.

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 medicine.

It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is eculizumab given?

In adults, eculizumab is usually given once a week for 5 weeks, and then once every 2 weeks thereafter. This schedule may be different for a child or teenager. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

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

Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it. Prepare your dose only when you are ready to give an injection. Do not shake the medication bottle or you may ruin the medicine. If you are using the injections at home, be sure you understand how to properly mix and store the medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

The medicine may be cold after you mix it. To reduce discomfort during your injection, allow the mixed medicine to reach room temperature before using. Never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.

Eculizumab must be given slowly, and the infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children.

You may have an infusion reaction when the medicine is injected into the vein. If this happens, you may need to slow down the speed of your IV infusion, but the infusion should not take more than 2 hours to complete in an adult, or 4 hours in a child. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.

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.

If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any follow-up visits to your doctor.

During treatment with eculizumab and for at least 3 months after your last dose, make sure any doctor who treats you knows that you are using this medicine.

Store unopened vials in their original carton in the refrigerator. Protect from light and do not freeze. Throw away any unused vials after the expiration date on the label has passed.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

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. Signs of allergic reaction may occur while you are receiving your eculizumab injection.

Seek emergency medical attention or call your doctor right away if you notice any of these 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.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times during treatment and for 3 months after your last dose of eculizumab.

Call your doctor at once if you have any of these side effects during or after your treatment with eculizumab:

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

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 interact with eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now 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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