infliximab-dyyb (Inflectra)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

What is infliximab-dyyb, and how does it work?

  • Infliximab-dyyb is an antibody administered intravenously and is used for treating several chronic inflammatory diseases such as Crohn's disease, psoriatic arthritis, or rheumatoid arthritis. It is a biosimilar version of the biologic drug, infliximab (Remicade). Biologic drugs are drugs that are produced by natural, biologic processes, for example, within cells. A biosimilar version is a medication that works like the original biologic drug but is manufactured by a different company by a different process. Infliximab-dyyb works by blocking the effects of tumor necrosis factor alpha (TNF alpha), a substance made by cells of the body which has an important role in promoting inflammation. There are two other injectable drugs that block TNF alpha--adalimumab (Humira) and etanercept (Enbrel).
  • Infliximab-dyyb reduces the signs and symptoms of inflammation by blocking the action of TNF-alpha. Infliximab-dyyb does not cure Crohn's disease, psoriatic arthritis, or rheumatoid arthritis. Infliximab-dyyb can retard the destruction of joints by rheumatoid arthritis.
  • The FDA approved Infliximab-dyyb in April 2016.

What brand names are available for infliximab-dyyb?

  • Inflectra is the brand name available for infliximab-dyyb in the US.

Is infliximab-dyyb available as a generic drug?

  • No, this drug is not available in generic form.

Do I need a prescription for infliximab-dyyb?

  • Yes, a patient must obtain a prescription by a doctor or other health care professional to receive this medication.

What are the uses for infliximab-dyyb?

Infliximab-dyyb is a medication that belongs to the class of drugs called biologics, and is approved for the treatment of the following health conditions.

  • Crohn's and pediatric Crohn's disease: Reducing signs and symptoms and inducing and maintaining clinical remission in children and adult patients with moderate to severe disease who did not fully respond to conventional therapy. It also is used for the treatment of adult patients with fistulas due to Crohn's.
  • Ulcerative Colitis: Reducing signs and symptoms and inducing and maintaining clinical remission and mucosal healing (healing of the lining of the colon), and eliminating corticosteroid use in adult patients with ulcerative colitis who did not fully respond to conventional therapy.
  • Rheumatoid Arthritis: Infliximab-dyyb is used in combination with the medication methotrexate (Trexall, Rheumatrex) to reduce signs and symptoms, reduce structural damage, and slow the progression of rheumatoid arthritis.
  • Ankylosing Spondylitis: Reducing signs and symptoms of ankylosing spondylitis (a type of arthritis).
  • Psoriatic Arthritis: Reducing signs and symptoms, reducing structural damage, and slowing the progression of active psoriatic arthritis.
  • Plaque Psoriasis: It is used for treatment of adult patients with chronic severe plaque psoriasis who need oral or injectable medications when other oral or injectable medications are medically less appropriate.

Why is there a black box warning for infliximab-dyyb?

Infliximab type products have a BLACK BOX WARNING, and are associated with increased risk of serious infections leading to hospitalization or death. These infections include:

  • Tuberculosis (TB)
  • Bacterial sepsis
  • Invasive fungal infections (such as histoplasmosis)
  • Infections due to other opportunistic pathogens. Infliximab-dyyb should be stopped if a serious infection develops.
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients received treatment with tumor necrosis factor (TNF) blockers, including infliximab products.
  • Post marketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers, including infliximab products.
Medically Reviewed by a Doctor on 1/31/2017

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