Soliris

Generic name: Eculizumab

What is Soliris?

Soliris is an injectable medicine used to treat paroxysmal nocturnal hemoglobinuria (PNH), a disease that affects red blood cells. Soliris works by blocking part of your immune system. This can help improve your PNH symptoms, but it can also increase your chance for infection.

What is the most important information I should know about Soliris?

Soliris is a monoclonal antibody that affects your immune system. It can lower your ability to fight infections. Therefore, it is very important that you have all recommended immunizations before you start treatment with Soliris and to stay up-to-date with immunizations during treatment.

Soliris increases your chance of getting serious and life-threatening meningococcal infections. You must receive a meningococcal vaccine at least 2 weeks before your first dose of Soliris unless you have already had this vaccine, in which case you might need a booster dose before starting Soliris. Your doctor will decide. The vaccine does not prevent all meningococcal infections. You must be aware of the following signs and symptoms of a meningococcal infection: confusion, fever of ≥103°F, moderate-to-severe headache associated with nausea or vomiting, fever, or with a stiff neck or back, rash, severe muscle aches with flu-like symptoms, and sensitivity to light. Call your doctor or get emergency medical care right away if you have any of these symptoms:

You will receive a Patient Safety Card that lists these symptoms and what to do if you have them. Carry it with you at all times. You will need to show the card to any healthcare provider that treats you.

Stopping treatment with Soliris may cause a sudden and serious breakdown of your red blood cells. Symptoms or problems from red blood cell breakdown include: confusion, chest pain, kidney problems, and blood clots. Your doctor will monitor you closely for at least 8 weeks after stopping Soliris.

Who should not take Soliris?

You should not take Soliris if you have a meningococcal infection, or if you have not been vaccinated with, or you are not up-to-date with, a meningococcal vaccine.

What should I tell my doctor before I take the first dose of Soliris?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Soliris. Also, talk to your doctor about your complete medical history, especially if you have an infection or fever. Inform your doctor if you are pregnant, planning to become pregnant, or if you are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual starting dose is 600 milligrams (mg) every 7 days for the first 4 weeks, followed by 900 mg for the fifth dose 7 days later, then 900 mg every 14 days thereafter.

How should I take Soliris?

Soliris is administered by a healthcare professional in a clinical setting. The drug is given through a vein (IV infusion) over 35 minutes. You will usually receive a Solaris infusion every 7 days for 5 weeks, then every 14 days. Following each infusion, you may be monitored for 1 hour for possible allergic reactions.

What should I avoid while taking Soliris?

Avoid situations that increase your exposure to infections, since Solaris weakens your immune system.

What are possible food and drug interactions associated with Soliris?

Drug interaction studies have not been performed with Solaris. But tell your doctor about any other prescription, over-the-counter, or herbal medications you are taking.

What are the possible side effects of Soliris?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: headaches, runny nose and colds, sore throat, back pain, nausea

Call your doctor if you have any of these side effects. These are not all the side effects with Soliris. Ask your doctor for more information.

Can I receive Soliris if I am pregnant or breastfeeding?

The effects of Solaris during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Soliris?

If you miss an appointment for your Soliris infusion, call your doctor right away.

Stopping treatment may cause a sudden and serious breakdown of your red blood cells. Symptoms or problems from red blood cell breakdown include: anemia, confusion, chest pain, kidney problems, and blood clots. Your doctor will need to monitor you closely for at least 8 weeks after stopping Soliris.

How should I store Soliris?

The medication will be stored and administered in a healthcare facility.