Soliris (Eculizumab)

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Eculizumab Information

ECULIZUMAB (ek yoo LYE zyoo mab) is a monoclonal antibody. It is used to treat a rare kind of anemia called paroxysmal nocturnal hemoglobinuria or PNH. It may help prevent the loss of blood in patients with PNH.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

They need to know if you have any of these conditions: -infection -not received meningococcal vaccine -an unusual or allergic reaction to this eculizumab, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Your condition will be monitored carefully while you are receiving this medicine. You will need regular blood work. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may have sudden breakdown of your red blood cells after you stop taking this medicine. You will need to be followed by your doctor for 8 weeks or more after this therapy is complete. This medicine may decrease your body's ability to fight infection. Avoid being around people who are sick. Carry the Patient Safety Card given to you at all times. Seek medical help if you have any of the symptoms listed on the card.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -back pain -breathing problems -bruising, pinpoint red spots on the skin -confusion -eyes sensitive to light -fast, irregular heartbeat -fever, chills, or any other sign of infection -pain, swelling, warmth in the leg -pain, tingling, numbness in the hands or feet -problems with balance, talking, walking -seizures -stiff neck -unusually weak or tired -vomiting Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -aches and pains -constipation -headache -nausea -runny nose or colds -sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Eculizumab Solution for injection