The chance of contracting meningococcal infection which can harm the covering of the brain and spinal cord and/or spread via the bloodstream during treatment or for some time afterward may increase if you receive eculizumab injection. Meningococcal infections have the potential to result in mortality quickly. To lessen the likelihood that you will get this kind of infection, you must have a meningococcal vaccination at least two weeks before starting therapy with the injection of eculizumab. Before starting your therapy, you might need to take a booster dose if you have previously had this vaccine. You will get your meningococcal vaccine as soon as feasible, unless your doctor determines that you need to start eculizumab injectable therapy right away.

Even if you take the meningococcal vaccine, there is still a chance that you could contract the disease while receiving the eculizumab injection or afterward. Get emergency medical assistance or call your doctor right away if you develop any of the following symptoms: Fever exceeding 103°F (39.4°C) or higher, rash, fever, confusion, muscular aches, and other flu-like symptoms, as well as if your eyes are sensitive to light are all signs that you should seek medical attention.

Before starting your eculizumab injection therapy, let your doctor know if you have a fever or any other signs of infection. If you currently have a meningococcal infection, your doctor will not administer the eculizumab injection.

A patient safety card that details the possibility of contracting meningococcal disease while receiving treatment or for some time after will be given to you by your doctor. Throughout your treatment and for three months after it, keep this card on you at all times. All of your medical professionals who treat you should see the card so they are aware of your risk.

Eculizumab injection risks have been reduced with the implementation of a programme called Soliris REMS. Only a doctor who has signed up for this programme, who has discussed the dangers of meningococcal disease with you, who has given you a patient safety card, and who has made sure you’ve had the meningococcal vaccine can administer eculizumab injection to you.

When you start therapy with eculizumab injection and after each injection, your doctor or chemist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of receiving an injection of eculizumab with your doctor.

Eculizumab injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a form of anaemia in which the body breaks down too many red blood cells, leaving insufficient numbers of healthy cells to carry oxygen throughout the body. Atypical hemolytic uremic syndrome (aHUS), an inherited illness in which the body develops tiny blood clots that may harm blood vessels, blood cells, the kidneys, and other organs, is similarly treated with eculizumab injection. Another condition that can be treated with eculizumab injection is a specific type of myasthenia gravis (MG), a neurological illness that causes muscle weakness. It is additionally used to treat some adults with neuromyelitis optica spectrum disease (NMOSD), an autoimmune neurological illness that affects the spinal cord and eye nerves. In the class of drugs known as monoclonal antibodies is the injectable eculizumab. It functions by preventing the immune system’s component from damaging blood cells, as it might in PNH patients, and causing clots to form in aHUS patients. Additionally, it functions by stymieing nerve and muscle transmission in those with MG or NMOSD to prevent the immune system’s ability to attack specific areas of the central nervous system.

In a medical office, a doctor or nurse will administer eculizumab injection intravenously (into a vein) over the course of at least 35 minutes. Adults often receive it once per week for the first five weeks, then once every other week. Depending on their age and weight, children may receive eculizumab injections on a different schedule. Additionally, extra eculizumab injectable doses may be administered before or after specific additional PNH, aHUS, MG, or NMOSD treatments.

Your doctor will likely start you on a low dose of the injectable eculizumab and then gradually raise it over the course of four weeks.

Serious adverse responses are possible with eculizumab injection. Your doctor will keep a close eye on you while you receive the eculizumab injection and for an hour afterward. If you experience an adverse response, your doctor may reduce or stop your infusion. Tell your doctor right away if you suffer any of the following symptoms: Chest pain, feeling lightheaded, rash, hives, swelling of the eyes, face, lips, tongue, or throat, hoarseness, or trouble breathing or swallowing are some of the other symptoms.

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

Before receiving eculizumab injection,

• If you have any allergies, including to eculizumab injection, other medicines, or any of the chemicals in eculizumab injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
• Inform your doctor and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor of any additional medical conditions you now have or have ever had.
• If you have any allergies, including to eculizumab injection, other medicines, or any of the chemicals in eculizumab injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
• Inform your doctor and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Inform your doctor of any additional medical conditions you now have or have ever had.
• If you are having treatment for PNH, you should be aware that once you stop getting eculizumab injections, your disease can lead to an excessive number of red blood cells breaking down. During the first eight weeks after you stop your therapy, your doctor will closely monitor you and perhaps request laboratory testing. If you have any of the following symptoms: confusion, chest pain, breathing difficulties, or any other strange symptoms, call your doctor straight once.
• If you have aHUS and are having treatment for it, you should be aware that stopping eculizumab injections could result in blood clots forming in your body. During the first 12 weeks following the completion of your therapy, your doctor will closely monitor you and may request laboratory testing. Immediately contact your physician if you experience any of the following signs: Flushing, seizures, chest pain, difficulty breathing, difficulty speaking or understanding speech, confusion, sudden weakness or numbness of an arm or leg (especially on one side of the body), or of the face; sudden difficulty walking; dizziness; loss of balance; swelling in the arms or legs; or any other unusual symptoms.

Keep eating normally unless your doctor instructs you otherwise.

Call your doctor as soon as possible if you are running late for an eculizumab injection appointment.

The injection of eculizumab may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Headache
• Clogged nose
• Discomfort or swelling in the throat or nose
• Cough
• Having trouble falling or staying asleep
• Extreme fatigue
• Dizziness
• Joint or muscle ache
• Back ache
• Ache in the legs or arms
• Throat and mouth sores
• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Difficult or painful urinating

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

• Fever
• Edoema of the lower legs, lower arms, feet, ankles, or hands
• Rapid heart rate
• Weakness
• Light skin
• Breathing difficulty

Other negative effects after eculizumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you suffer a serious side event.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the eculizumab injection, your doctor will request specific lab tests.

If you have any inquiries about eculizumab injection, ask your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.