Eculizumab-aeeb (e-kue-LIZ-oo-mab - aeeb)

Treats paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. The medicine must be injected slowly, so your IV will need to stay in place for at least 35 minutes in adults and 1 to 4 hours in children.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, blood or bone marrow problems (including neutropenia), a weak immune system, or any kind of infection.
• This medicine can increase your risk for serious infections, including meningococcal infection. You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicine to prevent infections if you are to use this medicine right away. You will also be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times during treatment and for 3 months after treatment. Show the card to any doctor who treats you.
• This medicine can also cause an infusion reaction that can be life-threatening.
• For patients with PNH: When you stop receiving this medicine, you may develop hemolysis (breakdown of red blood cells). Your doctor will monitor you for at least 8 weeks.
• For patients with aHUS: When you stop receiving this medicine, you may develop a type of blood clot called thrombotic microangiopathy. Your doctor will monitor you for at least 12 weeks to watch for this.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Confusion, sensitivity to light, severe headache, nausea, vomiting, stiff neck
• Fast or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, weakness

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Diarrhea, stomach pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Runny or stuffy nose

If you notice other side effects that you think are caused by this medicine, tell your doctor

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