Generic Name: eculizumab (E kue LIZ oo mab)Brand Names: Soliris
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.
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.
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.
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.
Call your doctor for instructions if you miss a dose of this medication.
Symptoms of an eculizumab overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
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:
runny nose, sore throat; or
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.
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.
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.