eculizumab

Generic Name: eculizumab (E kue LIZ oo mab)
Brand Name: Soliris

What is eculizumab?

Eculizumab is a monoclonal antibody. Eculizumab binds to proteins in the blood that can destroy red blood cells in people with genetic conditions that affect 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 is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS)

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

What is the most important information I should know about eculizumab?

Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).

You should not use this medication if you have bacterial meningitis or if you have not been vaccinated against meningitis. Tell your doctor if you have a fever or any type of infection.

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster dose.

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Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis: headache and fever with nausea or vomiting, high fever (103 degrees or higher), body aches, flu symptoms, confusion, increased sensitivity to light, stiffness in your neck or back.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. Carry this card with you at all times.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

What should I discuss with my health care provider before taking eculizumab?

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. Even 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 while you are using eculizumab, and your doctor may recommend other vaccines before or during treatment.

Children being treated with eculizumab may also need to be vaccinated against influenza or pneumonia before treatment begins.

You should not use this medication if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.

To make sure you can safely use eculizumab, tell your doctor if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Eculizumab is available only under a special program called Soliris REMS. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

How is eculizumab given?

Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Eculizumab is usually given once a week for 5 weeks, and then once every 2 weeks thereafter. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Eculizumab must be mixed in an IV bag with a liquid (diluent) before injecting it.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not shake the medication bottle or you may ruin the medicine. Prepare your dose only when you are ready to give an injection. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

To reduce discomfort from your injection, allow the mixed medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. You may store the mixture at room temperature but you must use it within 24 hours or throw the mixture away.

You may have a reaction to the infusion (when the medicine is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, but the infusion should not take more than 2 hours to complete. A caregiver or family member should then watch you for at least 1 hour after your injection to make sure you have no further side effects.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not stop using eculizumab without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

If you stop using eculizumab for any reason, your blood may need to be tested on a regular basis for 8 to 12 weeks. Do not miss any scheduled visits to your doctor during this follow-up period.

Store unopened vials in their original carton in the refrigerator. Protect from light and do not freeze. Throw away any unused vials after the expiration date on the label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking eculizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Eculizumab side effects

Seek emergency medical attention or call your doctor right away if you notice any of these symptoms of meningitis:

  • headache and fever with nausea or vomiting;

  • high fever (103 degrees or higher), body aches, flu symptoms;

  • confusion, increased sensitivity to light; or

  • stiffness in your neck or back.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these side effects during or after your treatment with eculizumab:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pain or burning when you urinate;

  • swelling, rapid weight gain, urinating less or not at all;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden severe headache, problems with vision, speech, or balance;

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs; or

  • increased blood pressure (severe headache, blurred vision, buzzing in your ears, shortness of breath).

Common side effects may include:

  • mild headache;

  • nausea, vomiting, diarrhea;

  • back pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

Eculizumab dosing information

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria:

Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 900 mg for the fifth dose 7 days later.
Maintenance dose: 900 mg via 35 minute IV infusion every 14 days.

Usual Adult Dose for Hemolytic Uremic Syndrome:

Atypical Hemolytic Uremic Syndrome:
Initial dose: 900 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 1200 mg for the fifth dose 7 days later.
Maintenance dose: 1200 mg via 35 minute IV infusion every 14 days.

Usual Pediatric Dose for Hemolytic Uremic Syndrome:

Patient body weight 40 kg or more: Initial dose: 900 mg via 35 minute IV infusion every 7 days for the first 4 weeks, followed by 1200 mg for the fifth dose 7 days later.
Maintenance dose: 1200 mg via 35 minute IV infusion every 14 days.

Patient body weight 30 kg to less than 40 kg: Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 2 weeks, followed by 900 mg for the third dose 7 days later.
Maintenance dose: 900 mg via 35 minute IV infusion every 14 days.

Patient body weight 20 kg to less than 30 kg: Initial dose: 600 mg via 35 minute IV infusion every 7 days for the first 2 weeks, followed by 600 mg for the third dose 7 days later.
Maintenance dose: 600 mg via 35 minute IV infusion every 14 days.

Patient body weight 10 kg to less than 20 kg: Initial dose: 600 mg via 35 minute IV infusion once, followed by 300 mg for the second dose 7 days later.
Maintenance dose: 300 mg via 35 minute IV infusion every 14 days.

Patient body weight 5 kg to less than 10 kg: Initial dose: 300 mg via 35 minute IV infusion once, followed by 300 mg for the second dose 7 days later.
Maintenance dose: 300 mg via 35 minute IV infusion every 21 days.

What other drugs will affect eculizumab?

Other drugs may interact with eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about eculizumab.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01. Revision Date: 2013-02-14, 2:33:56 PM.

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