SOLIRIS- eculizumab injection, solution, concentrate 
Alexion Pharmaceuticals Inc.

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MEDICATION GUIDE
Soliris® (so-leer-is)
(eculizumab)

Read the Medication Guide before you start Soliris and before each infusion.  This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.  Talk to your doctor if you have any questions about your treatment with Soliris.

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

Soliris is a medicine that affects your immune system.  Soliris can lower the ability of your immune system to fight infections.

Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.

  1. You must receive a meningococcal vaccine at least 2 weeks before your first dose of Soliris unless you have already had this vaccine.  If your doctor decided that urgent treatment with Soliris is needed, you should receive a meningococcal vaccine as soon as possible.
  2. If you had a meningococcal vaccine in the past, you might need a booster dose before starting Soliris.  Your doctor will decide if you need another dose of a meningococcal vaccine.
  3. A meningococcal vaccine does not prevent all meningococcal infections.  Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
    • headache with nausea or vomiting
    • headache and a fever
    • headache with a stiff neck or stiff back
    • fever of 103° F (39.4° C) or higher
    • fever and a rash
    • confusion
    • muscle aches with flu-like symptoms
    • eyes sensitive to light

Your doctor will give you a Patient Safety Card about the risk of meningococcal infection.  Carry it with you at all times during treatment and for 3 months after your last Soliris dose.  Your risk of meningococcal infection may continue for several weeks after your last dose of Soliris.  It is important to show this card to any doctor or nurse who treats you.  This will help them diagnose and treat you quickly. 

Soliris is only available through a program called the Soliris REMS.  Before you can receive Soliris, your doctor must:

Soliris may also increase the risk of other types of serious infections.  If your child is treated with Soliris, make sure that your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenza type b (Hib).

What Is Soliris?

Soliris is a prescription medicine called a monoclonal antibody.  Soliris is used to treat people with:

Soliris works by blocking part of your immune system.  This can help your symptoms but it can also increase your chance for infection.  

It is important that you:

Who Should Not Receive Soliris?

Do not receive Soliris if you:

What should I tell my doctor before receiving Soliris?

Before receiving Soliris, tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medications you take.  Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How will I receive Soliris?

       Symptoms or problems that can happen due to red blood cell breakdown include:

            o    drop in the number of your red blood cell count

            o    drop in your platelet count

            o    confusion

            o    chest pain

            o    kidney problems

            o    blood clots

            o    difficulty breathing

Symptoms or problems that can happen with abnormal clotting may include:

            o    stroke

            o    confusion

            o    seizures

            o    chest pain (angina)

            o    difficulty breathing

            o    kidney problems

            o    swelling in arms or legs

            o    a drop in your platelet count

What are the possible side effects of Soliris?

Soliris can cause serious side effects including:

If you have an allergic reaction to Soliris, your doctor may need to infuse Soliris more slowly, or stop Soliris.  See “How will I receive Soliris?”

Common side effects in people with PNH treated with Soliris include:

Common side effects in people with aHUS treated with Soliris include:

Tell your doctor about any side effect that bothers you or that does not go away.  These are not all the possible side effects of Soliris.  For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

General information about Soliris

Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Soliris.  If you would like more information, talk with your doctor.  You can ask your doctor or pharmacist for information about Soliris that is written for healthcare professionals.

What are the ingredients in Soliris?

Active ingredient: eculizumab

Inactive ingredients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 (vegetable origin) and Water for Injection

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by Alexion Pharmaceuticals, Inc., 352 Knotter Drive, Cheshire, CT 06410 USA.

Revised: 04/2014

Revised: 04/2014
 
Alexion Pharmaceuticals Inc.