What is Soliris?
Soliris is a monoclonal antigen. Eculizumab is a monoclonal antibody that binds to blood proteins and can destroy the red blood cell in people who have genetic conditions that interfere with the red blood cell's natural defenses. Soliris prevents the breakdown of red cells in adults who have paroxysmal nighttime hemoglobinuria.
Soliris can also be used to treat adults and children with a rare blood disorder called atypical hematuric syndrome. Soliris can also be used to treat myasthenia gravis among adults. Soliris can also be used to treat adults with neuromyelitis spectrum disorder (NMOSD). Soliris is only available under a specific program. To use this medicine, you must register with the programme.
Warnings
Soliris can affect your immune system. You could get serious or even fatal infections. You should call your doctor if you experience a headache with a fever, nausea, or vomiting. A card will be sent to you listing the symptoms associated with meningococcal disease. Learn what symptoms you should be on the lookout for by reading this information. You should keep the card on you while taking Soliris and for 3 months following your last dose.
Soliris should not be used if you are suffering from bacterial meningitis or if your meningitis vaccination has not been completed. Call your doctor or seek emergency medical care if you experience any of the following symptoms: meningitis: headache, fever, nausea, or vomiting; skin rash: body aches, flu, confusion, sensitivity or lightness, stiffness, or pain in your neck and back.
Soliris must be administered at least two weeks after you have been vaccinated for meningococcal disease. Consult your doctor before stopping Soliris. If you stop or interrupt your treatment, it could have serious and sudden effects on your blood cells.
Similar/related drugs
Pyridostigmine, Mestinon, Neostigmine, Ultomiris, Vyvgart, Eculizumab, and Empaveli
Before you take this drug
Soliris should not be used if you:
- You have a meningococcal infection.
- You have not received a vaccination against meningitis.
If you experience fever or any type of infection, do not hesitate to inform your physician. Your doctor may recommend specific vaccines. Soliris must be administered at least two weeks after you have been vaccinated. You may need to receive a booster shot if you have been vaccinated before. You should follow your doctor's advice when using it during pregnancy. A doctor can tell you if breastfeeding is safe while taking Soliris.
How to take Soliris?
Soliris is administered by a healthcare professional into a vein. In adults, the infusion may take up to four hours. Soliris will be tested by your doctor to ensure that it is the best treatment for you. Soliris should not be taken every day. Do not forget to follow your doctor's instructions. Dosing may differ for children and teenagers compared to adults.
Weight is used to determine the dose for children and adolescents.If your child loses or gains weight, their dose may need to change accordingly. After each infusion, you should be closely monitored for at least an hour to ensure that there is no reaction.
You could get infected more easily. This includes serious infections that can be fatal. You'll need to undergo frequent medical tests. A card will be sent to you listing the symptoms associated with meningococcal disease. Learn what symptoms you should be on the lookout for by reading this information. You should keep the card on you while taking Soliris and for 3 months following your last dose.
Consult your doctor before stopping Soliris. If you interrupt your treatment, it could have serious and sudden effects on your blood red cells. Eculizumab may affect your body for up to three months. If you stop taking this medication, you may need to undergo medical tests for up to 8–12 weeks. Tell any doctor that treats you that you have used Soliris.
Details on dosage
Adult dose for paroxysmal nocturnal hemoglobinuria
After 4 weeks of 600 mg IV per week, 900mg IV is given at week 5. Then a 900-mg IV is given every 2 weeks.
Use: To reduce hemolysis in paroxysmal nighttime hemoglobinuria
Adult dose for hemolytic uremic syndrome:
After the first four weeks, 900 mg is given IV each week. Then 1200 mg at week five and 1200 mg every two weeks.
Use: To inhibit complement-mediated microangiopathy in atypical hemolytic uremic syndrome (ahus).
Adult dose for Myasthenia gravis:
After the first four weeks, 900 mg is given IV each week. Then 1200 mg at week five and 1200 mg every two weeks.
Use: Patients with gmg who have anti-acetylcholine receptor (achr), antibody-positive
Adult dose for neuritis:
After the first four weeks, 900 mg is given IV each week. Then 1200 mg at week five and 1200 mg every two weeks.
Use: To treat adult patients with anti-aquaporin-4 antibodies who have neuromyelitis spectrum disorder (NMOSD).
The usual pediatric dose for hemolytic uremic syndrome:
Two months or older
Weight: 5 kg to 10 kg: 300mg IV in the first dose. 300mg IV in week 2, 300 mg IV every three weeks.
Weight 10 kg to 20 kg: 600mg IV first dose followed by 300mg IV week 2 and 300mg IV every two weeks
Weight 20 kg to 30 kg: 600 mg IV every two weeks for the first dose, then 600mg IV in week three, and 600 mg IV every two weeks thereafter.
Weight 30 kg or less: 600 mg IV for the first two doses. Then 900mg IV in week three, then 900 mg IV every 2 weeks.
Weight 40 kg and greater: 900mg IV per week for the 4 first doses. Then 1200 mg IV in week 5. Finally, 1200 mg IV every 2 weeks.
Use: To inhibit complement-mediated microangiopathy in atypical hemolytic uremic syndrome (ahus).
What happens if I miss the dose?
Contact your doctor to get the instructions.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Side effects of Soliris
If you experience any of the following symptoms of an allergic reaction: hives, chest pain, difficulty breathing, feeling as if you could pass out, or swelling of your lips, face, tongue, or throat, call 911. These side effects may occur after the injection.
If you experience any of the meningitis symptoms, seek immediate medical attention.
- A fever, headache, and skin rash are all symptoms of a febrile illness.
- Headache with nausea
- Body aches and flu symptoms
- Confusion and increased sensitivity to light
- You may experience stiffness in your neck or spine.
Call your doctor immediately if:
- Fever;
- Pain or burning after urinating;
- Dangerously elevated blood pressure—dizziness, weakness, numbness, confusion, blurred sight, vomiting, chest discomfort, cough, shortness of breath, seizure.
- Kidney disease: swelling, less urination, feeling tired, or short of breath
- Signs and symptoms of a blood-cell disorder: pale skin, unusual fatigue, feeling lightheaded, cold feet and hands, easy bruises, unusual bleeding, confusion, chest pain, trouble breathing, or seizures (convulsions);
- Signs of a Blood Clot: sudden numbness, weakness, difficulty speaking or balancing, rapid breathing, blood in the cough, or pain or swelling on your arms or legs.
Soliris may cause side effects such as:
- Headache, dizziness;
- Flu symptoms (fever and fatigue, sore throat, cough).
- Runny or stuffy nasal congestion, sinus pain
- Painful urination
- Nausea, vomiting, diarrhea, and stomach pain;
- Swelling in the legs or feet
- Bruising;
- Back pain, muscle, or joint
- A blood cell disorder;
- High blood pressure
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Interaction with other drug
Other drugs, such as vitamins and herbal remedies, may also interact with eculizumab. Inform your doctor of all the medicines you are taking and those that you stop or start using.
