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Eculizumab

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Warning

Eculizumab can lower your body's ability to fight an infection. It can increase your chance of getting a very serious (possibly fatal) brain/spinal cord infection (meningitis). Get medical help right away if you develop any signs of a severe infection (including meningitis), such as nausea/vomiting that doesn't stop, high fever, chills, severe headache, stiff neck, mental/mood changes (such as confusion), eye sensitivity to light.

You should receive the vaccine for meningitis (meningococcal vaccine) at least 2 weeks before receiving this medication. If you have been previously vaccinated for meningitis, ask your doctor if you need to be vaccinated again before receiving this medication. The vaccine will protect most people, but meningitis may occur even in people who have been vaccinated. You should still watch for signs of meningitis even if you receive the vaccine. Consult your doctor for more details.

To receive eculizumab in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before using eculizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent infection (especially of meningitis), vaccination history (especially for meningitis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Eculizumab can make you more likely to get certain infections (such as gonorrhea). Talk to your doctor for more details.

You may be vaccinated against certain infections before starting this medication. Tell your health care professional that you are using eculizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

See also Warning and How to Use sections.

Headache, tiredness, diarrhea, nausea/vomiting, or muscle pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as cough/sore throat that doesn't go away, fever, painful/frequent urination), muscle cramps, swelling hands/ankles/feet, fast heartbeat, signs of kidney problems (such as change in the amount of urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Information expires December 2024.