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Soliris

Generic Name: eculizumab (E kue LIZ oo mab)
Brand Names: Soliris

Medically reviewed: April 5, 2018

What is Soliris?

Soliris (eculizumab) is a monoclonal antibody. Eculizumab binds to proteins in the blood that can destroy red blood cells in people with genetic conditions that affect the natural defenses of red blood cells.

Soliris is used to prevent the breakdown of red blood cells in people with paroxysmal nocturnal hemoglobinuria (PNH).

Soliris is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS)

Soliris is also used to treat myasthenia gravis in adults.

Soliris is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Important Information

You should not use Soliris if you have bacterial meningitis or if you have not been vaccinated against meningitis.

You must be vaccinated against meningococcal infection at least 2 weeks before treatment with Soliris. If you have been vaccinated in the past, you may need a booster dose.

Seek emergency medical attention or call your doctor right away if you have symptoms of meningitis: headache and fever with nausea or vomiting, skin rash, body aches, flu symptoms, confusion, sensitivity to light, stiffness in your neck or back.

You will receive a card listing the symptoms of meningococcal infection. Read this information and learn what symptoms to watch for. Keep the card with you at all times while using Soliris and for at least 3 months after your last dose.

Do not stop receiving Soliris without first talking to your doctor. Stopping or interrupting your treatment could cause sudden and serious effects on your red blood cells.

Before taking this medicine

You should not use Soliris if you are allergic to eculizumab, or if:

  • you have bacterial meningitis; or

  • you have not been vaccinated against meningitis.

Tell your doctor if you have a fever or any type of infection.

You must be vaccinated against meningococcal infection at least 2 weeks before you start treatment with Soliris. If you were vaccinated in the past, you may need a booster dose.

Your doctor may also recommend other vaccines while you are using Soliris.

Follow your doctor's instructions about using Soliris if you are pregnant. It is very important to control your blood disorder during pregnancy to avoid unwanted effects in you or the baby.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

How is Soliris given?

Soliris is given as an infusion into a vein. A healthcare provider will give you this injection. The infusion can take at least 35 minutes to complete in adults, or up to 4 hours in children.

Soliris is not given every day. Follow your doctor's dosing instructions very carefully. The dosing schedule may be different for a child or teenager than for an adult.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Doses are based on age and weight in children, and any changes may affect your child's dose.

You should be watched closely for at least 1 hour after each infusion, to make sure you do not have an allergic reaction.

Soliris affects your immune system. You may get infections more easily, even serious or fatal infections, during treatment and for up to 3 months after your last dose.

You will receive a card listing the symptoms of meningococcal infection. Read this information and learn what symptoms to watch for. Keep the card with you at all times while using Soliris and for at least 3 months after your last dose.

Do not stop receiving Soliris without first talking to your doctor. Interrupting your treatment could cause sudden and serious effects on your red blood cells.

Soliris can have long-lasting effects on your body (up to 3 months). You may need frequent medical tests for 8 to 12 weeks if you stop using this medicine for any reason. Make sure any doctor who treats you knows that you've used Soliris.

Soliris dosing information

Usual Adult Dose of Soliris for Paroxysmal Nocturnal Hemoglobinuria:

600 mg IV every week for 4 weeks, followed by 900 mg IV at week 5, then 900 mg IV every 2 weeks

Comments:
-Administer this drug IV over 35 minutes in adults.
-Administer this drug at the recommended time, or within 2 days of the recommended time.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 2 hours in adults.
-The patient should be monitored for infusion reactions for at least 1 hour following the infusion.
-Monitor patients with PNH for hemolysis for at least 8 weeks after the final dose.

Use: For paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis

Usual Adult Dose of Soliris for Hemolytic Uremic Syndrome:

900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks

Comments:
-Administer this drug IV over 35 minutes in adults.
-Administer this drug at the recommended time, or within 2 days of the recommended time.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 2 hours in adults.
-The patient should be monitored for infusion reactions for at least 1 hour following the infusion.
-Monitor patients with aHUS for thrombotic microangiopathy (TMA) complications for at least 12 weeks after the final dose.

Use: For atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy

Usual Adult Dose of Soliris for Myasthenia Gravis:

900 mg IV every week for the first 4 weeks, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks

Comments:
-Administer this drug IV over 35 minutes in adults.
-Administer this drug at the recommended time, or within 2 days of the recommended time.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 2 hours in adults.
-The patient should be monitored for infusion reactions for at least 1 hour following the infusion.

Use: For patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive

Usual Pediatric Dose for Hemolytic Uremic Syndrome:

2 months and older:
-Weight 5 kg to less than 10 kg: 300 mg IV for the first dose, followed by 300 mg IV at week 2, then 300 mg IV every 3 weeks
-Weight 10 kg to less than 20 kg: 600 mg IV for the first dose, followed by 300 mg IV at week 2, then 300 mg IV every 2 weeks
-Weight 20 kg to less than 30 kg: 600 mg IV every week for the first 2 doses, followed by 600 mg IV at week 3, then 600 mg IV every 2 weeks
-Weight 30 kg to less than 40 kg: 600 mg IV every week for the first 2 doses, followed by 900 mg IV at week 3, then 900 mg IV every 2 weeks
-Weight 40 kg or greater: 900 mg IV every week for the first 4 doses, followed by 1200 mg IV at week 5, then 1200 mg IV every 2 weeks

Comments:
-Administer this drug IV over 1 to 4 hours in pediatric patients.
-Administer this drug at the recommended time, or within 2 days of the recommended time.
-If an adverse reaction occurs, the infusion may be slowed or stopped at the discretion of the physician. If the infusion is slowed, the total infusion time should not exceed 4 hours in pediatric patients.
-The patient should be monitored for infusion reactions for at least 1 hour following the infusion.
-Monitor patients with aHUS for thrombotic microangiopathy (TMA) complications for at least 12 weeks after the final dose.

Use: For atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Soliris?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Soliris side effects

Get emergency medical help if you have signs of an allergic reaction to Soliris: hives; chest pain, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. These symptoms may occur during the injection.

Seek emergency medical attention if you have symptoms of meningitis:

  • fever and a headache or skin rash;

  • headache with nausea and vomiting;

  • high fever (103 degrees F or higher), body aches, flu symptoms;

  • confusion, increased sensitivity to light; or

  • stiffness in your neck or back.

During or after your treatment with Soliris call your doctor at once if you have:

  • fever;

  • pain or burning when you urinate;

  • kidney problemslittle or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • signs of a blood cell disorderpale skin, unusual tiredness, feeling light-headed, cold hands and feet, easy bruising, unusual bleeding, confusion, chest pain, trouble breathing, seizure (convulsions); or

  • signs of a blood clotsudden numbness or weakness, problems with speech or balance, rapid breathing, coughing up blood, pain or swelling in your arms or legs.

Common Soliris side effects may include:

  • headache;

  • nausea, vomiting, diarrhea, stomach pain;

  • swelling in your legs or feet;

  • cold symptoms such as runny or stuffy nose, sinus pain, cough, sore throat;

  • joint pain, back pain; or

  • increased blood pressuresevere headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Soliris?

Other drugs may interact with eculizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Soliris only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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