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Eculizumab is available as a 300 mg/30 mL (10 mg/mL) single-dose vial.

Eculizumab is a type of monoclonal antibody used to treat:

• Paroxysmal nocturnal hemoglobinuria (PNH) in adults
• Atypical hemolytic uremic syndrome (aHUS) in adults and children
• Generalized myasthenia gravis (gMG)) in certain people who are 6 years and older
• Neuromyelitis optica spectrum disorder (NMOSD)) in certain adults

Eculizumab is a complement inhibitor. It blocks the complement system, which is part of your immune system. In some autoimmune problems, the complement system doesn’t work as it should and becomes overly active. This causes the immune system to attack parts of your own body and lead to symptoms. By blocking the complement system from working, Eculizumab is thought to help relieve symptoms of certain autoimmune problems.

Eculizumab is dosed as follows:

• Adults
• PNH: The typical dose is 600 mg as an infusion through the vein (IV) every week for the first 4 weeks, 900 mg on week 5, then 900 mg every 2 weeks thereafter.
• AHUS, gMG, or NMOSD: The typical dose is 900 mg IV every week for the first 4 weeks, 1,200 mg on week 5, then 1,200 mg every 2 weeks thereafter.
• Children’s doses are based on weight and determined by their healthcare provider.

Eculizumab is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

• Unresolved serious Neisseria meningitidis infection

Common side effects of Eculizumab:

• Headache
• Cold-like symptoms
• Back pain
• Nausea
• Tiredness
• Cough
• Diarrhea
• Vomiting
• High blood pressure
• Anemia

Serious side effects are rare with Eculizumab. Contact your healthcare provider immediately if you experience any of the following:

• Meningococcal infection: headache, stiff neck or back, muscle ache, nausea, vomiting, fever, flu-like symptoms, sensitivity to bright light, confusion, rash
• Serious infusion reaction: chest pain; trouble breathing; shortness of breath; feeling faint or wanting to pass out; itchiness; swelling of the face, tongue, or throat

The following medications may interact with Eculizumab:

• Neonatal Fc receptor (FcRn) blockers

Various FDA-approved generic manufacturers

It is not known whether this medication is safe for you and your unborn baby during pregnancy. Talk to your doctor if you are already pregnant or if you have plans on becoming pregnant. They will recommend what is best for you.

• Soliris