Soliris

Soliris (Eculizumab injection) is a monoclonal antibody. It is used for the management of a blood disease called paroxysmal nocturnal hemoglobinuria (PNH). It reduces the red blood cell destruction or breakdown (hemolysis) in patients with PNH. It can be used for treating serious kidney disorder called atypical hemolytic uremic syndrome (aHUS). This medicine is used only with a restricted distribution program called Soliris REMS (Risk Evaluation and Mitigation Strategy) Program.

Soliris is a prescription drug and must be used only with doctor's supervision. Treatment with Soliris requires certain precautions because it makes the patient more vulnerable to infections. 

Soliris has several important requirements and limitations.

Risk of Meningitis

Note that Soliris can greatly increase your risk of having meningitis, a condition caused by inflammation of membranes surrounding the brain. This risk is high during and for at least 3 months after using Soliris. You must be vaccinated against bacteria that cause meningitis (meningococcal vaccine) at least two weeks before receiving Soliris. If you have received the meningococcal vaccine before, you must take a booster dose before using Soliris. You cannot take Soliris if you have meningitis.

Other health conditions

Because Soliris can make you more vulnerable to infections, you have to make the doctor know if you have symptoms of infection such as fever, sore throat, or a cough before treatment.

Use on children and elderly

Soliris can be used on children under doctor’s supervision. However, children need to be vaccinated against influenza and pneumonia before starting treatment.

Elderly patients need to be closely monitored when treated with Soliris.

Pregnancy and breastfeeding

You must tell the doctor if you are pregnant or breastfeeding before taking Soliris. Soliris is an FDA pregnancy category C drug, which means it may not be completely safe to the fetus in pregnant patients. It is possible that Soliris may be passed into breast milk, so do not nurse while using the drug. 

Soliris is injected into the veins (intravenous route). Your dose of Soliris is determined by your doctor. Soliris is usually given once a week for the first five weeks, and then at higher dose once every two weeks.Soliris is also given as a supplement dose during plasmapheresis or infusion of fresh blood plasma.

The dose of Soliris is based on your body weight, so report to your doctor if you have significant changes in weight. Make sure to follow the doctor’s instructions in taking Soliris.

Infusion of Soliris requires special equipment, and the drug itself have very specific preparation instructions. Soliris is also infused very slowly and can take at least two hours or more. Your health providers will prepare and administer Soliris, and will have to do monitoring for at least an hour after infusion. Thus, you must have Soliris only at the hospital or doctor’s clinic.

It is very important not to miss doses of Soliris, which can result in sudden serious side effects. If you missed a dose of Soliris, call your doctor right away and head to the hospital. Overdosing on Soliris is unlikely because it is given by health professionals and you will be monitored throughout and after infusion.

You must be seen frequently by the doctor when you are having treatment with Soliris. Make sure to keep up with clinic appointments and lab tests.

Each vial of Soliris is single-use only, so it must be thrown away after extracting the medicine, even if there is still some liquid left. Do not reuse or store opened Soliris vials for later infusion.

You must be monitored for at least an hour after administration of Soliris. At this time, make sure to contact your health providers right away for any untoward symptoms.

If you are taking Soliris, do not take any other medicine without your doctor’s approval.

Soliris may cause side effects. Call the doctor if you experience the following during or after infusion of Soliris:

• Severe allergic reaction symptoms such as hives, chest pain, difficulty breathing, lightheadedness,  swelling of the face, lips, mouth, or tongue.
• Symptoms of possible meningitis such as a headache, high fever, skin rash, body aches and other flu symptoms, stiffness in the back or neck, confusion, and increased sensitivity to light
• Symptoms of possible kidney problems such as passing too little or no urine, swelling of the feet or ankles, tiredness or shortness of breath
• Symptoms of possible blood cell disorder such as paleness, easy bruising, bleeding tendencies, confusion, chest pain, difficulty breathing, and having seizures
• Symptoms of possible blood clot in the circulation such as sudden numbness or weakness, speech or balance difficulties, rapid breathing, coughing up blood, pain or swelling in the legs
• Low or high fever
• Pain or burning sensation during urination

Soliris may cause minor side effects such as:

• Headache
• Back pain
• Increased blood pressure
• Nausea and vomiting
• Diarrhea
• Stomach upset
• Swelling of the hands or feet
• Cold symptoms