Soliris (eculizumab) is used to treat certain nerve problems, such as myasthenia gravis. It can also help with rare blood problems, like paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. This medication is a monoclonal antibody known as a complement inhibitor. It's given as an infusion through the vein by a healthcare professional. Side effects include headache, nausea, and high blood pressure. There's also a risk of serious meningococcal infection. So, it's only available through a special program called the Soliris Risk Evaluation and Mitigation Strategy (REMS). Currenly, Soliris (eculizumab) is a brand-name medication only.
Soliris (eculizumab) is a type of monoclonal antibody called a complement inhibitor. It blocks the complement system, which is part of your immune system.
In some autoimmune problems, the complement system doesn't work as it should and becomes overly active. This causes the immune system to attack parts of your own body and lead to symptoms.
By blocking the complement system from working, Soliris (eculizumab) is thought to help relieve symptoms of certain autoimmune problems.
| Common Brands | Soliris |
|---|---|
| Drug Class | Complement inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
PNH:
aHUS:
gMG:
NMOSD:
PNH:
aHUS:
gMG:
NMOSD:
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Back pain
black, tarry stools
bladder pain
blindness
bloody or cloudy urine
blurred vision
body aches or pain
burning or stinging of the skin
burning, dry, or itching eyes
chest pain or tightness
chills
cough producing mucus
difficult, burning, or painful urination
difficulty breathing or swallowing
difficulty with moving
dizziness
ear congestion
fast heartbeat
frequent urge to urinate
general feeling of discomfort or illness
headache
joint pain or swelling
loss of appetite
loss of voice
lower back or side pain
muscle ache, cramp, pain, or stiffness
nervousness
pain or tenderness around the eyes and cheekbones
painful cold sores or blisters on the lips, nose, eyes, or genitals
pale skin
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
shivering
slow or fast heartbeat
sores, ulcers, or white spots on the lips or in the mouth
stuffy or runny nose
sweating
swollen glands
trouble breathing
trouble sleeping
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What to expect with Soliris (eculizumab) infusions:
Soliris (eculizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Soliris (eculizumab) can raise the risk of meningococcal infection. This infection can be very serious and life-threatening. It can affect the brain and spinal cord and cause meningitis. It can also affect the blood and lead to septicemia.
Because of this risk, Soliris (eculizumab) is only available through a special safety program. Your care team will help you enroll in the Soliris Risk Evaluation and Mitigation Strategy (REMS) program. Your prescriber and the pharmacy you get the medication from must also enroll. This makes sure you and everyone involved in your care know about the dangers and steps to lower the risk.
At least 2 weeks before starting Soliris (eculizumab), you'll need to get vaccinated against meningococcal infection series. If you must start the medication right away, complete the vaccination series as soon as you can. In this case, you'll also need to take antibiotics to help protect you. Vaccines don't fully prevent infection, but they help lower the risk.
Talk to your prescriber about the symptoms of a meningococcal infection to look out for. Some include fever, stiff neck, sensitivity to bright lights, and confusion. If this happens, get medical care right away.
Soliris (eculizumab) can raise your risk of other serious infections. These can include bacterial infections like pneumococcal infection and gonorrhea. Certain fungal infections like aspergillosis are also possible. You're at higher risk of this fungal infection if you have a weak immune system or a low white blood cell count.
If your child is taking Soliris (eculizumab), they should be vaccinated to protect them from some infections. They should get the pneumococcal vaccine. They should also get vaccinated against Haemophilus influenzae type b (Hib). Children taking this medication are at higher risk of these infections. Talk to your child's prescriber about vaccinations.
For people with PNH, Soliris (eculizumab) helps stop red blood cells from breaking down too fast. But when you stop treatment, the effects of the medication could go away. This means your red blood cells can break down quickly again and cause problems.
Your care team will continue to check in with you for at least 2 months after you stop Soliris (eculizumab). Tell them if you feel unusually tired, dizzy, or weak. Also let them know if you feel your heart racing. These could be signs of problems from stopping the medication.
For people with aHUS, stopping Soliris (eculizumab) can lead to clotting problems called thrombotic microangiopathy (TMA). When this happens, your body forms little blood clots in your smallest blood vessels. You can also have a low red blood cell count, low platelets, and other abnormal lab results.
Your prescriber will follow up with you for at least 3 more months after stopping Soliris (eculizumab). This can help them check for any problems you might experience afterwards. Be sure to tell your care team if you feel confused of breath or confused. Also let them know if you have chest pain, swelling in the arms or legs, a blood clot, or a seizure. These can be signs of problems from TMA.
Although rare, there's a risk of having a reaction to the Soliris (eculizumab) infusion. They can include life-threatening reactions like anaphylaxis.
To be safe, your nurse will keep an eye on you during your Soliris (eculizumab) infusion. But also let your nurse know right away if you feel your heart racing, have trouble breathing, or feel chest pain. If you have a reaction, the nurse might slow or stop your infusion and treat these symptoms.
Adults
Children younger than 18 years old with aHUS or children 6 to 18 years old with gMG
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Soliris (eculizumab) will not be safe for you to take.
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Soliris is given as an intravenous infusion. This means it's given as an injection through the vein. You need to go to a medical center so that a nurse can administer the medication to you. For adults, each infusion takes at least 35 minutes. And for children, the infusion can last 1 to 4 hours. Talk to your care team to learn more about what to expect with Soliris infusions.
The Soliris REMS, or Risk Evaluation and Mitigation Strategy, is a special safety program for this medication. This is because it has a risk of serious meningococcal infection. You, your prescriber, and the pharmacy must all sign up with this program. The REMS program helps make sure everyone involved in your care is aware of this danger. It also makes sure everyone knows about the dangerous, the signs to look out for, and ways to lower the risk. Soliris is only available through this restricted program. Talk to your prescriber to learn more about the Soliris REMS program.
Some people can call Soliris an immunosuppressant. The medication works to block a part of your immune system called the complement system. Normally, your immune system fights against germs. But when part of your immune system is blocked, your immune system might be weaker than usual. This can make it more likely for you to get serious infections. Tell your prescriber right away if you have signs of an infection while taking this medication. Look out for headaches, fever, stiff neck, muscle aches, flu-like symptoms, nausea, sensitivity to light, or confusion. This can be early signs of a serious infection called meningococcal infection.
In studies, some people with NMOSD who took Soliris reported hair loss. In general, it doesn't seem common though. If you notice hair shedding or thinning during treatment, talk to your care team. They can help figure out what might be going on.
During studies, people didn't report weight gain while taking Soliris. If you notice changes in weight that worry you during treatment, talk to your prescriber. For children, it's extra important to tell the prescriber about weight changes. The dose for children changes with weight, so the prescriber should check if the dose needs to be adjusted.
The pharmaceutical company Alexion Pharmaceuticals makes Soliris.
Get vaccinated against meningococcal infection at least 2 weeks before your first infusion of Soliris. If you need to start the medication right away and you haven't gotten vaccinated yet, you'll get prescribed antibiotics to take. Then, get vaccinated as soon as you can. These steps help prevent serious meningococcal infection. Children with aHUS or gMG will also need to get vaccinated against certain other germs before starting. They should get vaccinated against Hib bacteria and pneumococcal bacteria (which causes pneumonia). Talk to your prescriber to check what you need to do.
Soliris and Ultomiris (ravulizumab) are both monoclonal antibodies that work in the same way to treat the same health conditions. They're both infusions that are given through the vein. But you'll need to get Soliris infusions more often than Ultomiris infusions. For most people, Soliris is given every week for the first couple weeks, then every 2 weeks after that. Ultomiris is generally given every 8 weeks (or every 4 weeks for children of certain weight). Talk to your prescriber to compare and help you decide which is right for you.
