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Drugs reference index «eculizumab»

eculizumab


eculizumab

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

What is eculizumab?

Eculizumab is a monoclonal antibody that binds to proteins in the blood that can destroy red blood cells in people with a genetic condition that affects 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 may also be used for other purposes not listed in this medication guide.

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

Eculizumab affects your immune system, and using this medication may increase your risk of serious infection such as meningitis. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and/or seizure (convulsions) and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a very high fever (103 degrees or higher), chills, body aches, or other flu-like symptoms.

With your medication you will receive a Patient Safety Card listing the symptoms of meningitis. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

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

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. Get emergency medical help if you have any signs of meningitis, such as severe headache with fever, confusion, purple spots on the skin, and nausea or vomiting, stiffness in your neck or back, sensitivity to bright light, or a high fever (103 degrees or higher), chills, body aches, and other flu-like symptoms.

With your medication you will receive a Patient Safety Card listing the symptoms of meningococcal infection. Carry this card with you at all times. Seek emergency medical attention or call your doctor right away if you notice any of these symptoms.

You should not use this medication if you are allergic to eculizumab, or have bacterial meningitis. You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with eculizumab. 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.

Before using eculizumab, tell your doctor if you are allergic to any drugs or if you have a fever or any type of infection.

FDA pregnancy category C. It is not known whether eculizumab is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether eculizumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is eculizumab given?

Eculizumab is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Eculizumab is usually given every 7 days for 5 weeks, and then once every 2 weeks thereafter. The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.

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. 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.

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 vial (bottle). Vigorous shaking can ruin the medicine. Do not mix this medicine until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. 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.

Use each disposable needle only one time. Throw away used needles 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. This may result in symptoms such as pale skin, easy bruising, confusion, chest pain, blood clots, or kidney problems.

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

Store unopened eculizumab in its original carton in the refrigerator, protected from light. Do not allow the medication to freeze.

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 if you think you have used too much of this medicine.

Symptoms of an eculizumab overdose are not known.

What should I avoid while taking eculizumab?

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

Eculizumab side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:
  • severe headache with fever, confusion, purple spots on the skin, nausea or vomiting, and/or seizure (convulsions);

  • stiffness in your neck or back;

  • sensitivity to bright light;

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

  • any signs of a new illness or injection; or

  • signs that the medication is not working (pale skin, easy bruising, weakness, dark urine, feeling short of breath, or sudden numbness, severe headache, deep leg pain, or problems with vision, speech, or balance).

Less serious side effects may include:

  • nausea;

  • constipation;

  • mild headache;

  • runny nose, sore throat; or

  • back pain.

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.

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.

What other drugs will affect eculizumab?

There may be other drugs that can interact with eculizumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your 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.
  • 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 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 09/08/2009 2:31:04 PM.
  • eculizumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
  • Eculizumab Professional Patient Advice (Wolters Kluwer)
  • Eculizumab MedFacts Consumer Leaflet (Wolters Kluwer)
  • Soliris Consumer Overview

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