Overview: Eculizumab is an intravenous (IV) medicine used to treat certain rare and serious immune problems that affect your blood, muscles, or nerves. Common side effects include headache, infections, back pain, nausea, vomiting, and diarrhea. Serious infections, such as meningitis, can happen during treatment. Call your health care provider or get emergency medical help right away if you have a headache with fever, rash, nausea/vomiting, or stiff neck/back or if your eyes are sensitive to light. Keep all of your appointments for blood tests before, during, and after using eculizumab.
Uses
What is eculizumab used for?
Eculizumab is commonly used for certain people with the following rare and serious immune problems.
- Paroxysmal nocturnal hemoglobinuria (PNH), a condition where the immune system attacks red blood cells
- Atypical hemolytic uremic syndrome (aHUS), a condition where the immune system attacks blood vessels
- Generalized myasthenia gravis (gMG), a condition where the immune system attacks where muscle fibers and nerve cells meet
- Neuromyelitis optica spectrum disorder (NMOSD), a condition where the immune system attacks brain and spinal cord cells
Eculizumab may also be used for other conditions as determined by your health care provider.
How does eculizumab work (mechanism of action)?
Eculizumab is a monoclonal antibody. This medicine is man-made and works in your body like an antibody made in response to an infection. Eculizumab binds to a protein in your body called complement protein C5. The complement system is part of your immune system, so eculizumab affects your immune system.
As eculizumab binds to C5, it cannot be used to make a substance that causes red blood cell destruction in people with paroxysmal nocturnal hemoglobinuria (PNH) or blood clots in small blood vessels in people with atypical hemolytic uremic syndrome (aHUS). Eculizumab is thought to work similarly for people with generalized myasthenia gravis. Eculizumab prevents the formation of a substance that causes damage where muscle fibers and nerve cells meet.
In certain people with neuromyelitis optica spectrum disorder (NMOSD), eculizumab appears to interrupt cell damage caused by complement. Complement activation appears to play a major role in people with NMOSD and antibodies against a protein called aquaporin-4 (AQP4).
How is eculizumab supplied (dosage forms)?
Brands and other names
- Bkemv
- Epysqli
- Soliris
Dosage forms and strengths
Eculizumab is available in an injectable form that is given by a health care provider.
How should I store eculizumab?
Eculizumab is usually given by a health care provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of eculizumab?
The most common side effects of eculizumab are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.
- Headache
- Infections in the nose or throat, sore throat, or common cold symptoms
- Back pain
- Stomach pain, nausea, or vomiting
- Diarrhea
- High blood pressure
- Low red blood cells (anemia)
- Cough
- Fluid retention in your legs, feet, ankles, and arms (peripheral edema)
- Kidney or bladder infection
- Fever
- Muscle or joint pain
- Dizziness
- Flu-like symptoms (influenza)
- Bruising
There may be other side effects of eculizumab that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of eculizumab?
While less common, the most serious side effects of eculizumab are described below, along with what to do if they happen.
Severe Allergic Reactions. Eculizumab may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Serious Infections. Eculizumab may increase your risk of serious infections that can be life threatening, including meningitis and blood infection (sepsis). Even if you have received all of your recommended vaccines, you can still get a serious infection. Call your health care provider or get emergency medical care right away if you have any of the following.
- Fever
- Fever with high heart rate
- Headache and fever
- Confusion
- Muscle aches with flu-like symptoms
- Fever and rash
- Headache with nausea or vomiting
- Stiffness in your back or neck
- Eyes become sensitive to light
- Fast breathing or trouble breathing
- Very low body temperature
- Peeing less than usual or not at all
- Tiredness or weakness
- Sweating
- Severe pain
- Slurred speech
- Unconsciousness
Infusion Reactions. Eculizumab can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away if you have any of the following symptoms when you get your infusion.
- Chest pain
- Trouble breathing or shortness of breath
- Swelling of your face, tongue, or throat
- Feel faint or pass out
Warnings & Precautions
Who should not use eculizumab?
Allergies to Ingredients. People who are allergic to any of the following should not use eculizumab.
- Bkemv
- Eculizumab
- Epysqli
- Soliris
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in the specific eculizumab products they stock.
Infection. People who have an unresolved serious infection such as a blood or central nervous system infection caused by a bacteria called Neisseria meningitidis should not use eculizumab.
What should I know about eculizumab before using it?
Eculizumab is usually given by a health care provider as an infusion into your vein (IV) in a hospital or clinic.
Eculizumab is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including labs or other testing, while using eculizumab. Ask your health care provider if you have any questions.
You may have serious blood problems or certain infections after you stop using eculizumab. Keep all appointments after stopping this medicine so your health care provider can monitor you for these problems.
Your health care provider will likely give you a patient safety card that provides information about the serious side effects of eculizumab. Carry this card with you at all times during treatment and for three months after your last dose. Show this card to any health care provider who treats you.
If you have not received all of your meningitis vaccine shots, your health care will likely recommend you get your meningitis vaccine(s) at least two weeks before your first dose of eculizumab. Your health care provider may give you antibiotics if you have to start eculizumab right away and you have not gotten all of your meningitis vaccines. Take these antibiotics as prescribed for as long as your health care provider tells you. Ask your health care provider if you have any questions.
Eculizumab may lower your ability to fight certain types of infections. Your health care provider will likely give you information about how to prevent a serious infection called gonorrhea and when to get tested if you are at risk. If you have a child who is receiving eculizumab, you should make sure they receive certain vaccines, including the pneumonia vaccine, Haemophilus influenzae type b (Hib) vaccine, and meningococcal vaccine, to protect against certain infections. Ask your health care provider if you have any questions.
What should I tell my health care provider before using eculizumab?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if eculizumab is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Weak immune system or get infections easily
- Low white blood cells
- Infection or fever
Vaccines. Talk with your health care provider about any vaccines that you may need. Tell your health care provider about any vaccines you have recently received or have scheduled.
Other Medicines and Supplements. Eculizumab may interact with other medicines and supplements. Before using eculizumab, tell your health care provider about any prescription or OTC medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how eculizumab could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use eculizumab while you are pregnant or trying to get pregnant.
Breastfeeding. It is not known if eculizumab passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use eculizumab while breastfeeding.
Interactions
Does eculizumab interact with foods or drinks?
There are no known interactions between eculizumab and foods or drinks.
It is unknown if drinking alcohol will affect eculizumab. The risk of dizziness or tiredness may increase if you drink alcohol while taking eculizumab.
Does eculizumab interact with other medicines (drug interactions)?
Always tell your health care provider about any prescription or OTC medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using eculizumab.
- Certain types of blood treatment called plasma exchange (PE), plasmapheresis (PP), or fresh frozen plasma
- Intravenous immunoglobulin (Gammagard, Privigen, and others), which is a medicine used to treat certain immune system problems or inflammatory conditions
- Efgartigimod (Vyvgart, Vyvgart Hytrulo), which is a medicine used to treat certain immune system problems
Some other medicines may alter the blood levels of eculizumab. Tell your health care provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with eculizumab. Always check with your health care provider.
Overdose/Missed Dose
What should I do if I accidentally use too much eculizumab?
If you or someone else has used too much eculizumab, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of eculizumab?
Eculizumab is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving eculizumab as scheduled.
If you miss an appointment to get your eculizumab dose, call to make another appointment as soon as possible.
Are you currently using Eculizumab (Soliris)?
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