golimumab (Simponi, Simponi Aria)

  • 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 golimumab, and how does it work?

  • Golimumab is an injectable synthetic (man-made) protein that binds to tumor necrosis factor alpha (TNFα) in the body and blocks the effects of TNFα in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. As a result, the inflammation caused by these diseases and its consequences are reduced. Adalimumab (Humira), certolizumab (Cimzia) and etanercept (Enbrel) are two other injectable drugs that block TNFα.
  • Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is an protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. The unchecked inflammation of rheumatoid and psoriatic arthritis as well as ankylosing spondylitis eventually leads to destruction of the joints. Golimumab binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its inflammatory consequences in joints are reduced, and the progressive destruction of the joints is slowed or prevented.
  • The FDA approved golimumab in April 2009.
  • Simponi and Simponi Aria are the brand names for golimumab available in the US.
  • Is golimumab available as a generic drug?

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

    Quick GuideRheumatoid Arthritis (RA) Symptoms & Treatment

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    Do I need a prescription for golimumab?

    • Yes, you need a prescription for this drug.

    What are the uses for golimumab?

    What are the side effects of golimumab?

    Common side effects include:

    • Flu
    • Elevated liver function test results
    • Fever
    • Abnormal prickling, tingling, tickling, or burning sensation (paraesthesia)

    Other side effects include:

    • Injection site reactions (redness, swelling)
    • Reduced levels of blood cells
    • Reactivation of hepatitis B virus
    • New onset or worsening of psoriasis

    Less common side effects include:

    Possible serious side effects include:

    Individuals with active infections should not be treated with golimumab. This drug may worsen or cause new diseases of the nervous system. It also may cause or worsen congestive heart failure. In studies, some patients who used golimumab or other TNFα blocking drugs developed cancer.

    What is the dosage for golimumab?

    • Golimumab is injected under the skin.
    • Injection sites should be rotated.
    • The recommended dose is 50 mg monthly.

    Which drugs or supplements interact with golimumab?

    Is golimumab safe to use during pregnancy or while breastfeeding?

    • There are no adequate studies of golimumab in pregnant women.
    • It is not known whether this drug is excreted in breast milk.

    What else should I know about golimumab?

    What preparations of golimumab are available?
    • Injection (Prefilled Syringe): 50 mg/0.5 ml
    How should I keep golimumab stored?
    • This drug should be stored refrigerated at 2 C to 8 C (36 F to 46 F).

    REFERENCE: FDA prescribing information for Simponi

    Quick GuideRheumatoid Arthritis (RA) Symptoms & Treatment

    Rheumatoid Arthritis (RA) Symptoms & Treatment

    Summary

    Golimumab (Simponi) is an injectable protein (man-made) used in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Side effects are

    Drug interactions, warnings and precautions, and pregnancy and breastfeeding information should be reviewed prior to taking any medication.

    Treatment & Diagnosis

    Medications & Supplements

    Prevention & Wellness

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    See more info: golimumab on RxList
    Reviewed on 1/27/2017
    References
    REFERENCE: FDA prescribing information for Simponi

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