(E kue LIZ oo mab) Brand: Soliris
• Eculizumab is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinemia (PNH).
• You must not use this medicine if you have bacterial meningitis or if you have not been vaccinated against meningitis. Speak your doctor if you have a fever or any type of infection.
• Eculizumab affects your immune system, and using this medicine may magnify your risk of serious infection such as meningitis. You should be vaccinated against meningococcal infection at least 2 weeks till you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster doze.
• Search abnormal medical attention or call your doctor right away if you announcement any of these symptoms of meningitis: headache and fever with nausea or vomiting, tall fever (103 degrees or higher), body aches, flu symptoms, confusion, heighten sensitivity to easy, stiffness in your neck or back.
• With your medicine you will receive a Patient Safe 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 reason sudden and serious effects on your red blood cells.
• 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 malady called atypical hemolytic uremic syndrome (aHUS)
• Eculizumab may also be used for purposes not listed in this medicine guide.
• Eculizumab affects your immune system, and using this medicine may magnify your risk of serious infection such as meningitis.
• You should be vaccinated against meningococcal infection at least 2 weeks till you start treatment with eculizumab. Even if you have been vaccinated in the past, you may need a booster doze.
• It is excellent to remain current on all of your vaccinations while you are using eculizumab, and your doctor may recommend another vaccines till or during treatment.
• Children being treated with eculizumab may also need to be vaccinated against influenza or pneumonia till treatment begins.
• You must not use this medicine if you are allergic to eculizumab, if you have bacterial meningitis, or if you have not been vaccinated against meningitis.
• To create certain you can safely use eculizumab, speak 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 child. Speak 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 child. Speak your doctor if you are breast-feeding a baby.
• Eculizumab is accessible only under a particular program called Soliris REMS. You should be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.
• Eculizumab is injected into a vein through an IV. You may be shown how to use an IV at house. Do not self-inject this medication if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and another items used to inject the medicine.
• Eculizumab is generally given once a week for 5 weeks, and then once each 2 weeks thereafter. Follow all directions on your prescription label. Do not use this medication in larger or less amounts or for longer than recommended.
• Eculizumab should be mixed in an IV bag with a liquid (diluent) till injecting it.
• If you are using the injections at house, be certain you understand how to properly mix and store the medicine. Do not shake the medicine bottle or you may ruin the medication. Prepare your doze only when you are ready to give an injection. Do not use if the medication has changed colors or has particles in it. Call your pharmacist for new medicine.
• To reduce discomfort from your injection, let the mixed medication to reach room temperature till using, but never warm the medication in hot water or a microwave. You may store the mixture at room temperature but you should use it within 24 hours or throw the mixture away.
• You may have a reaction to the infusion (when the medication is injected into the vein). If this happens, you may need to slow down the speed of your IV infusion, but the infusion must not take more than 2 hours to complete. A caregiver or family member must then watch you for at least 1 hour after your injection to create certain you have no further side effects.
• Every single-use vial (bottle) of this medication is for one use only. Throw away after one use, even if there is still some medication 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). Hold 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 reason sudden and serious effects on your red blood cells.
• If you stop using eculizumab for any cause, 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 easy and do not freeze. Throw away any unused vials after the expiration date on the label has passed.
• Call your doctor for instructions if you miss a doze of this medication.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Follow your doctor's instructions about any restrictions on food, beverages, or activity.
• Search abnormal medical attention or call your doctor right away if you announcement any of these symptoms of meningitis:
· headache and fever with nausea or vomiting;
· tall fever (103 degrees or higher), body aches, flu symptoms;
· confusion, heighten sensitivity to easy; or
· stiffness in your neck or back.
• With your medicine you will receive a Patient Safe Card listing the symptoms of meningococcal infection. Carry this card with you at all times.
• Get abnormal 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 person, 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 course, trouble concentrating;
· light 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 smaller 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
· heighten blood pressure (severe headache, blurred vision, buzzing in your ears, shortness of breath).
• General side effects may include:
· mild headache;
· nausea, vomiting, diarrhea;
· back pain; or
· cool 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 message side effects to FDA at 1-800-FDA-1088.
• Another drugs may interact with eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal commodity. Speak every of your health care providers about all medicines you use now and any medication you start or stop using.
• Your doctor or pharmacist can provide more information about eculizumab.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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