Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.
From the official U.S. FDA label for golimumab, the active ingredient registered with NAFDAC.
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. …
The most serious adverse reactions were: Serious Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
None. None ( 4 )
Serious Infections: Do not start SIMPONI ARIA during an active infection. If an infection develops, monitor carefully, and stop SIMPONI ARIA if infection becomes serious ( 5.1 ). Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI ARIA, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic ( 5.1 ). Hepatitis B Reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop SIMPONI ARIA and begin anti-viral therapy ( 5.1 ). Malignancies: More cases of lymphoma have been observed among patients receiving TNF blockers compared with patients in the control groups. …
8.1 Pregnancy Risk Summary Available data from postmarketing case reports with golimumab use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. An observational study of northern European births observed similar unadjusted rates of major birth defects in infants exposed in utero to golimumab compared to no treatment or non-biologic systemic therapy. …
Refrigerate SIMPONI ARIA at 36 ⁰F to 46 ⁰F (2 ⁰C to 8 ⁰C) and protect from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. …
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Simponi Solution for Injection in Prefilled Pen contains Golimumab (50 mg/0.5 mL), as solution for injection, according to its NAFDAC registration record.
Yes. Simponi Solution for Injection in Prefilled Pen is listed on the NAFDAC register under registration number A6-100193, and its registration is active as of 5 November 2026.
No WHO falsified or substandard medical product alert currently matches Simponi Solution for Injection in Prefilled Pen in our automatically synced alert list.
Run a free authenticity scan with the NAFDAC number A6-100193, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA (Summarised from the official U.S. FDA label for golimumab. Always follow your doctor or pharmacist.)
Reviews are personal experiences from RxVerify users, not medical advice. Report side effects to your doctor and to NAFDAC.