Soliris

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

What is Soliris?

Soliris 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.

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

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

Important information about Soliris

Soliris 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, skin rash, 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 Soliris. 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 Soliris, and your doctor may recommend other vaccines before or during treatment.

Before taking Soliris

Soliris 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, skin rash, 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 Soliris 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 Soliris. 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 Soliris, and your doctor may recommend other vaccines before or during treatment.

Before using Soliris, 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. Soliris may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Soliris passes into breast milk or if it could harm a nursing baby. Do not use Soliris without telling your doctor if you are breast-feeding a baby.

How is Soliris given?

Soliris 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.

Soliris 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.

Soliris 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 Soliris 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 Soliris 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 Soliris 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 Soliris.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an Soliris overdose are not known.

What should I avoid while taking Soliris?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Soliris.

Soliris 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, skin rash, and nausea or vomiting;

• 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. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Soliris?

There may be other drugs that can interact with Soliris. 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 Soliris.

• Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 12/04/2007 4:15:19 PM.

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