Soliris

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

Warnings

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

Soliris affects your immune system. You may get infections more easily, even serious or fatal infections.

You must be vaccinated against meningococcal infection at least 2 weeks before treatment with Soliris.

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.

Your doctor may recommend certain vaccines while you are using Soliris. 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.

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.

Your doctor will perform a blood test to make sure Soliris is the right treatment for your condition.

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.

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

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

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 to avoid

  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;
  • body aches, flu symptoms;
  • confusion, increased sensitivity to light; or
  • stiffness in your neck or back.