Eculizumab

Eculizumab is used for:

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Treating a certain type of blood disorder called paroxysmal nocturnal hemoglobinemia (PNH).

Eculizumab is a monoclonal antibody. It works by blocking part of the immune system. This helps to reduce the breakdown of red blood cells that occurs in patients who have PNH.

Do NOT use Eculizumab if:

• you are allergic to any ingredient in Eculizumab
• you have a meningococcal infection
• you are not vaccinated against meningococcal infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eculizumab :

Some medical conditions may interact with Eculizumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances, including mouse or murine proteins
• if you have an infection or fever

Some MEDICINES MAY INTERACT with Eculizumab . However, no specific interactions with Eculizumab are known at this time.

Ask your health care provider if Eculizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Eculizumab :

Use Eculizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Eculizumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Eculizumab refilled.
• Be sure you receive the Patient Safety Card that comes with Eculizumab . Carry it with you at all times. This card lists the symptoms of meningococcal infection and what to do if you have them. Seek medical help right away if you develop any symptoms on the card.
• You must receive a meningococcal vaccine at least 2 weeks before you start Eculizumab . If you have had this vaccination in the past, you might need a booster dose before starting Eculizumab . Check with your doctor.
• Eculizumab is usually given as an injection at your doctor's office, hospital, or clinic.
• Do not use Eculizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Do not shake Eculizumab .
• Do not stop Eculizumab without checking with your doctor. You may have a sudden and serious breakdown of your red blood cells (hemolysis). This can result in anemia, kidney problems, and blood clots. Symptoms may include confusion or chest pain. If you need to stop Eculizumab , your doctor will need to monitor your condition closely for at least 8 weeks after you stop using it.
• If you miss a dose of Eculizumab , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Eculizumab .

Important safety information:

• Eculizumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.
• Contact your doctor right away if you develop signs of meningococcal infection, even if you have had a meningococcal vaccine. These symptoms include moderate to severe headache along with nausea, vomiting, fever, stiff neck, or stiff back; confusion; high fever (higher than 103 degrees F); fever with a rash; eyes sensitive to light; or severe muscle aches with flu-like symptoms.
• Tell your doctor or dentist that you take Eculizumab before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including blood cell counts, hemoglobin levels, serum creatinine, and serum lactate dehydrogenase (LDH), may be performed while you use Eculizumab and for at least 8 weeks after you stop using it. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Eculizumab may cause a serious breakdown of red blood cells when you stop using it. Remain under the care of your doctor for at least 8 weeks after you stop using Eculizumab .
• Eculizumab should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Eculizumab while you are pregnant. It is not known if Eculizumab is found in breast milk. If you are or will be breast-feeding while you use Eculizumab , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Eculizumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; mild headache; nausea; nose, throat, or sinus irritation; tiredness; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain or tenderness; chest pain; confusion; coughing up blood; eyes sensitive to light; fever, chills, or persistent sore throat; mental changes; moderate to severe headache along with nausea, vomiting, fever, stiff neck, or stiff back; mouth sores or fever blisters; severe muscle aches with flu-like symptoms; shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http: / / www.aapcc.org / dnn / Resources / FindLocalPoisonCenters / tabid / 130 / Default.aspx), or emergency room immediately.

Eculizumab is usually handled and stored by a health care provider. If you are using Eculizumab at home, store Eculizumab as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Eculizumab , please talk with your doctor, pharmacist, or other health care provider.
• Eculizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Eculizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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