What is Eculizumab?

  • It 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.
  • It is used to prevent the breakdown of red blood cells in adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • It is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who weigh at least 11 pounds (5 kilograms).
  • It is also used to treat myasthenia gravis in adults.
  • It is also used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults.
  • It is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Eculizumab is the first treatment to be approved to treat adults with anti-AChR Ab+ gMG in more than 60 years

Eculizumab works to help manage anti-acetylcholine receptor antibody-positive generalized Myasthenia Gravis (anti-AChR Ab+ gMG) by focusing on a specific part of your immune system.

In a clinical trial, some patients with gMG who responded to it experienced early symptom improvement by 12 weeks.

  • In a clinical trial of 125 patients,Eculizumab was shown to improve activities of daily living and muscle weakness in some patients with unresolved symptoms, despite multiple treatments
  • Clinical response in this trial was defined as:
    • ≥3-point improvement from baseline in MG-ADL total score at 26 weeks of treatment
    • ≥5-point improvement from baseline in quantitative MG (QMG) total score at 26 weeks of treatment
  • Of patients receivingEculizumab (n=62) or placebo (n=63)
    • MG-ADL: 60% reported an improvement in activities of daily living compared with 40% of those taking placebo
    • QMG: 45% had a clinically meaningful improvement in muscle weakness compared with 19% of those taking placebo
  • The 14-day infusion schedule for Soliris was carefully studied when determining safety and efficacy. It is important to follow your doctor’s prescribed treatment schedule and try to keep all of your infusion appointments within that 14-day time frame

Prednisone

Prednisone is used to treat many different inflammatory conditions such as arthritis, lupus, psoriasis, ulcerative colitis, allergic disorders, gland (endocrine) disorders, and conditions that affect the skin, eyes, lungs, stomach, nervous system, or blood cells.

IVIG

Intravenous immune globulin (“IVIG”) is a product made up of antibodies that can be given intravenously (through a vein). IVIG is given into a vein (“intravenously”), in an infusion that takes one hour or more. The amount of IVIG you need for each dose depends on your weight as well as the reason you are getting the IVIG:

Plasmapheresis/Apheresis

Plasmapheresis/Apheresis is a process in which the fluid part of the blood, called plasma, is removed from blood cells by a device known as a cell separator. The separator works either by passing the blood at high speed to separate the cells from the fluid or by passing the blood through a membrane with pores so small that only the fluid part of the blood can pass through. 

Eculizumab

Eculizumab is the first treatment to be approved to treat adults with anti-AChR Ab+ gMG in more than 60 years. Soliris works to help manage anti-acetylcholine receptor antibody-positive generalized Myasthenia Gravis (anti-AChR Ab+ gMG) by focusing on a specific part of your immune system.

Rituximab

Rituximab is a genetically engineered antibody that depletes CD20+ B-cells and is Food and Drug Administration- approved for treatment of non-Hodgkin lymphoma, CD20+ CLL, and rheumatoid arthritis. It carries a favorable side effects profile.