Soliris
Soliris (eculizumab) is used to treat many rare, blood- and nerve-related problems. This medication is given by a healthcare provider as an infusion through the vein to stop the body's immune system from attacking itself. Soliris (eculizumab) can suppress (block) the immune system and lower inflammation, but it can raise the risk of infections.
What is Soliris (eculizumab)?
What is Soliris (eculizumab) used for?
Blood-related problems
Nerve-related problems
How Soliris (eculizumab) works
Soliris (eculizumab) is a monoclonal antibody. This medication affects a process in the body called the complement system.
The complement system is part of your immune system. Its job is to fight against bacteria or remove foreign or damaged cells. Sometimes, this system can become overly active, and it attacks your healthy cells by mistake. This can result in conditions such as paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). These conditions are blood- and nerve-related problems.
The exact ways that Soliris (eculizumab) works to treat these conditions aren't known, but it's thought to help by stopping the complement system.
Drug Facts
What are the side effects of Soliris (eculizumab)?
Common Side Effects
- Headache (44%)
- Nose and throat infection (23%)
- Back pain (19%)
- Nausea (16%)
- Tiredness (12%)
- Cough (12%)
- Fever (21-50%)
- Headache (18-41%)
- Diarrhea (32-37%)
- Cough (23-36%)
- High blood pressure (18-33%)
- Stomach pain (19-32%)
- Upper respiratory tract infection ((e.g., common cold; 19-32%)
- Vomiting (21-30%)
- Nose and throat infection (27%)
- Anemia (low blood cell count; 26%)
- Nausea (23%)
- Swelling in arms and legs (23%)
- Urinary tract infection (UTI; 18-22%)
- Headache (26%)
- Nose and throat infection (24%)
- Diarrhea (15%)
- Muscle and bone pain (15%)
- Joint pain (12%)
- Upper respiratory tract infection (11%)
- Nausea (10%)
- Upper respiratory tract infection (29%)
- Nose and throat infection (21%)
- Diarrhea (16%)
- Dizziness (15%)
- Back pain (15%)
- Joint pain (11%)
- Flu (11%)
- Sore throat (10%)
- Bruising (10%)
Other Side Effects
- Constipation
- Lower appetite
- Muscle spasm
- Muscle pain
- Pain in arms or legs
- "Pins and needles" feeling
- Weakness
- Difficulty sleeping
- Fast heart rate
- Kidney problems
- Runny nose
- Flu-like symptoms
- Other respiratory tract or sinus infection
- Other infections (e.g., herpes, bladder, skin, stomach, catheter site)
- Eye infection or stye
- Cataract
- Rash
Serious Side Effects
- Meningococcal infection: headache, stiff neck or back, muscle ache, nausea, vomiting, fever, flu-like symptoms, sensitivity to bright light, confusion, rash
- Serious infusion-related reactions: chest pain, trouble breathing or shortness of breath, feeling faint or wanting to pass out, swelling of face, tongue, or throat
- Blood clots, other blood problems, or worsening of aHUS: stroke confusion, seizures, difficulty breathing, chest pain, kidney problems, swelling in arms or legs
Source:Â DailyMed
The following side effects have also been reported
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.
Pros and cons of Soliris (eculizumab)
Pros
Treatment given every 1 to 3 weeks
Works directly on immune system function to treat many conditions
Can be given to adults (all conditions) and children (aHUS only)
Monitored by a healthcare provider for reactions after each treatment
Cons
Only given by injection, so might not be comfortable for people who don't like needles
Need to receive certain vaccines before starting treatment
Higher risk of getting an infection
Can't be used to treat Shiga-toxin E. coli-related hemolytic uremic syndrome (STEC-HUS)
Pharmacist tips for Soliris (eculizumab)
Bring your vaccination records to your visit with your provider before starting Soliris (eculizumab) to make sure all of your vaccinations are complete. It's important your vaccines are up to date to lower your risk of infections while you're receiving this medication.
You'll be given a Soliris Patient Safety Information Card by your provider. Carry it with you at all times so you know when to get emergency medical help. Continue to carry this card for 3 months after stopping your treatment, because you're still at risk for developing an infection during that time.
Soliris (eculizumab) can raise your risk of serious infections, including meningitis and gonorrhea, so discuss with your provider on how to best prevent infection. If you're at a higher risk of developing gonorrhea, get tested regularly while you're receiving Soliris (eculizumab) treatment.
Let your provider know if you experience any reactions during or after your infusion so they can give you the appropriate treatment.
After stopping your treatment, continue to follow up with your provider in case you experience any problems or complications. Depending on your condition, you'll be monitored for at least 2 to 3 months after stopping your treatment.
It's not known if Soliris (eculizumab) can harm your unborn baby or pass into your breastmilk. Let your provider know if you're pregnant, planning to become pregnant, or breastfeeding so they can discuss if this medication is right for you.
Frequently asked questions about Soliris (eculizumab)
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What are the risks and warnings for Soliris (eculizumab)?
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.
Risk of serious infections
Soliris (eculizumab) can raise the risk of a serious and life-threatening infection called meningococcal infection. This infection can affect your brain and spinal cord (leading to meningitis) or your bloodstream (leading to septicemia, a serious blood infection). Due to the risk of meningococcal infection, Soliris (eculizumab) is only available through a restricted program called the Soliris Risk Evaluation and Mitigation Strategy (REMS). Your provider must be enrolled in this program before they can give you Soliris (eculizumab) and make sure they discuss this serious risk with you before you start therapy.
Your provider will require you to get the meningococcal vaccines at least 2 weeks before starting your treatment with Soliris (eculizumab) to help lower your risk of meningococcal infection. If you need to start this medication right away, then you'll need to get the vaccines as soon as possible and take antibiotics for 2 weeks. The meningococcal vaccines don't prevent you from getting the infection, but it can lower your risk. Speak with your provider about what meningococcal infection symptoms you should look out for and when to call them.
Soliris (eculizumab) might also raise your risk for getting other serious infections, such as gonorrhea and certain fungal infections (aspergillosis). The risk for fungal infections is higher if you have a weak immune system or have a low white blood cell count. Make sure your child is vaccinated against certain types of bacteria, including Streptococcus pneumoniae and Haemophilus influenzae type b (Hib), because they have a higher risk of developing these infections while getting Soliris (eculizumab) treatment.
Problems after stopping treatment
Stopping Soliris (eculizumab) treatment might cause your red blood cells to break down if you have PNH, or clotting problems called thrombotic microangiopathy (TMA) if you have aHUS. TMA is a problem where your body forms little blood clots in your smallest blood vessels. You can also have a low red blood cell count, low platelet levels, and organ damage. Your provider will follow up with you for any problems that you might experience after stopping your treatment (at least 2 months for PNH and at least 3 months for aHUS). Let your provider know if you experience signs and symptoms of TMA or red blood cell breakdown, such as confusion, seizures, chest pain, shortness of breath, swelling in arms or legs, or blood clots.
Reactions relating to infusion
Although rare, there is a risk of allergic reactions with Soliris (eculizumab) treatments. These reactions can include life-threatening reactions (e.g., anaphylaxis). During your infusion, let your provider know right away if you experience any heart or breathing problems, such as chest pain or shortness of breath. If you have a reaction, your provider might slow or stop your infusion and treat you appropriately.
Soliris (eculizumab) dosage forms
Typical dosing for Soliris (eculizumab)
The typical dosing can vary greatly depending on your condition, age, and weight.
Paroxysmal nocturnal hemoglobinuria (PNH)
Adults: The typical dose is 600 mg injected into the vein (IV) every week for the first 4 weeks, 900 mg on week 5, then 900 mg every 2 weeks thereafter.
Atypical hemolytic uremic syndrome (aHUS)
Adults and children weighing at least 88 lbs: The typical dose is 900 mg IV every week for the first 4 weeks, 1,200 mg on week 5, then 1,200 mg every 2 weeks thereafter.
Children 66 lbs to less than 88 lbs: The typical dose is 600 mg IV every week for the first 2 weeks, 900 mg on week 3, then 900 mg every 2 weeks thereafter.
Children 44 lbs to less than 66 lbs: The typical dose is 600 mg IV every week for the first 2 weeks, 600 mg on week 3, then 600 mg every 2 weeks thereafter.
Children 22 lbs to less than 44 lbs: The typical dose is 600 mg IV on week 1, 300 mg on week 2, then 300 mg every 2 weeks thereafter.
Children 11 lbs to less than 22 lbs: The typical dose is 300 mg IV on week 1, 300 mg on week 2, then 300 mg every 3 weeks thereafter.
Generalized myasthenia gravis (gMG) or neuromyelitis optica spectrum disorder (NMOSD)
Adults: The typical dose is 900 mg IV every week for the first 4 weeks, 1,200 mg on week 5, then 1,200 mg every 2 weeks thereafter.
Interactions between Soliris (eculizumab) and other drugs
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.
- Tofacitinib
Soliris (eculizumab) contraindications
Current infection caused by the bacteria Neisseria meningitidis (meningococcal infection)
Not vaccinated against Neisseria meningitidis bacteria (meningococcal vaccines), unless the provider approves treatment without these vaccines
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