Soliris (eculizumab)

Soliris^® (eculizumab) is a laboratory-made antibody approved for adults with neuromyelitis spectrum disorder (NMOSD) who have the AQP4 antibody (AQP4-IgG). Soliris is given by intravenous (through the vein, or IV) infusion, usually every 2 weeks. ^1,2

What are the ingredients in Soliris?

The active ingredient in Soliris is eculizumab. It is a lab-made antibody.¹

How does Soliris work?

Soliris works by blocking the last step in a pathway called the complement system. Your body uses this pathway to help fight off harmful bacteria and other pathogens. The complement system has been shown to be involved in the inflammatory response in NMOSD that leads to nerve damage. Blocking the complement pathway can prevent this inflammation and nerve damage.¹
Soliris binds to and inhibits a specific protein in the complement system called C5. Preventing complement system activation prevents the damaging effects of the immune system attacking its own healthy cells in NMOSD.¹

What are the possible side effects?

An increased risk of infection has been linked to other drugs like Soliris. Other common side effects of Soliris include:¹

• Headache
• Swelling of the nose and throat
• Upper respiratory infection
• Cough
• Back pain
• Nausea and vomiting
• Diarrhea
• Belly pain
• High blood pressure
• Decreased red blood cells
• Urinary tract infection
• Swelling of the lower legs or hands
• Fever
• Muscle and bone pain
• Dizziness
• Bruising

Soliris also has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA), because life-threatening and fatal meningitis has occurred in those who have taken Soliris.¹

Meningitis is an infection and inflammation of the layers of fluid and tissues surrounding your brain and spinal cord. Though this side effect is rare, before starting Soliris you will be given a vaccine (shot) to help prevent this kind of infection.¹

These are not all the possible side effects of Soliris. Talk to your doctor about what to expect when taking Soliris. You should also call your doctor if you have any changes that concern you when taking Soliris.

Other things to know

At least 2 weeks before starting Soliris, you will need to have a vaccine to protect you from meningitis. While this vaccine helps protect many people, there is still a risk of life-threatening or fatal meningitis.¹

Because of the risk of meningitis, your doctor will enroll you in a program designed to monitor any signs and symptoms you may have with Soliris.¹

Soliris is given by IV infusion. IV site reactions may occur, including life-threatening allergic reactions. In a clinical trial, there were no reported cases of this type of reaction in those who received Soliris.¹

There are people whose bodies fight against laboratory-made antibodies. This can make Soliris ineffective. It also may cause an allergic response or harmful side effects. Doctors cannot predict who will end up with this type of response.^1,3

It is not known if Soliris can harm an unborn baby. Small studies of pregnant women who took Soliris suggest it is safe, but more data is needed to be conclusive. Talk to your doctor if you or your partner are or plan to become pregnant before taking Soliris.¹

It is not known if Soliris can pass through breast milk. Doctors do not know the effect of Soliris on babies who are breastfed. There is no information on the effects of Soliris on milk production.¹

Some immunosuppressive drugs may slightly increase the risk of cancer in the long term. There are currently no long-term studies on Soliris and cancer risk.¹

Before beginning treatment for NMOSD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Soliris.¹