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Brand Names: Soliris

Generic Name: eculizumab (Pronunciation: E kue LIZ oo mab)

• What is eculizumab (Soliris)?
• What are the possible side effects of eculizumab (Soliris)?
• What is the most important information I should know about eculizumab (Soliris)?
• What should I discuss with my health care provider before taking eculizumab (Soliris)?
• How is eculizumab given (Soliris)?
• What happens if I miss a dose (Soliris)?
• What happens if I overdose (Soliris)?
• What should I avoid while taking eculizumab (Soliris)?
• What other drugs will affect eculizumab (Soliris)?
• Where can I get more information?

What is eculizumab (Soliris)?

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

What are the possible side effects of eculizumab (Soliris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);
• stiffness in your neck or back;
• sensitivity to bright light;
• high fever (103 degrees or higher), chills, body aches, flu symptoms;
• any signs of a new illness or injection; or
• signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

Less serious side effects may include:

• nausea;
• constipation;
• mild headache;
• runny nose, sore throat; or
• back pain.

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 is the most important information I should know about eculizumab (Soliris)?

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/or seizure (convulsions) and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a very high fever (103 degrees or higher), chills, body aches, or other flu-like symptoms.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. 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 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 before you receive eculizumab, and your doctor may recommend other vaccines before or during treatment.