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golimumab (Simponi)
Indications:
- for use in combination with methotrexate for treatment of rheumatoid arthritis [4,5]
- psoriatic arthritis [4]
- ankylosing spondylitis [4]
- ulcerative colitis [3]
Contraindications:
Pregnancy category: B [4]
Dosage:
- injection, 50 mg SC monthly
Monitor:
- screening for tuberculosis [4]
- CBC, LFTs, serum creatinine at baseline & every 3-6 months thereafter [4]
Adverse effects:
- risk of serious fungal infections, including histoplasmosis
Laboratory:
- golimumab in serum/plasma
- golimumab Ab in serum/plasma
Mechanism of action:
- TNF-alpha inhibitor
Notes:
- cost about $1500 a month (2009)
Interactions
drug adverse effects of immunosuppressive agents
monitor with immunosuppressive agents
General
recombinant protein; chimer
tumor necrosis factor (TNF) inhibitor
References
- FDA MedWatch - Simponi (golimumab)-Risk of serious
fungal infections associated with TNF-?lpha blockers,
including Simponi
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Simponi
- Prescriber's Letter 16(6): 2009
Simponi (Golimumab): A Monthly Injectable Drug for Arthritis
PATIENT HANDOUT: What I Need to Know About My Rheumatoid
Arthritis Medication
GUIDELINES: Use of Disease-Modifying Antirheumatic Drugs
(DMARDs) in Rheumatoid Arthritis
Detail-Document#: 250603
(subscription needed) http://www.prescribersletter.com
- FDA News Release: May 15, 2013
FDA approves Simponi to treat ulcerative colitis
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352383.htm
- Medical Knowledge Self Assessment Program (MKSAP) 16, 17, 18, 19.
American College of Physicians, Philadelphia 2012, 2015, 2018, 2022.
- Singh JA, Noorbaloochi S, Singh G.
Golimumab for rheumatoid arthritis: a systematic review.
J Rheumatol. 2010 Jun;37(6):1096-104
PMID: 20436075