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This section of the website is for UK healthcare professionals only. If you are not a healthcare professional, please click here.

What is SIMPONI® (golimumab) in Rheumatology

Prescribing Information

An animated outline of the key clinical data for SIMPONI in Rheumatoid Arthritis

Length: 02:41

More information about SIMPONI:

Important Safety Information1

For complete information on the prescribing and safety information relating to use of SIMPONI please refer to the Summary of Product Characteristics.

  • Do not use in patients with active tuberculosis, other severe infections, moderate/severe heart failure {NYHA class Ill/IV) or in patients with a history of hypersensitivity to SIMPONI or to any of the excipients.
  • Monitor patients for new or worsening heart failure. If suspected, SIMPONI must be discontinued.
  • Monitor patients closely for infections, including active and latent TB, before, during and five months after treatment.
  • Patients should be tested for HBV before initiating treatment with SIMPONI. For patients who test positive for HBV, consultation with a physician with expertise in the treatment of HBV is recommended.
  • SIMPONI has been associated with injection site reactions. Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following SIMPONI administration. Some of these occurred after the first administration.
  • Anti-TNFs have been associated with malignancies and lymphomas including HSTCL Caution should be exercised in initiating or continuing anti-TNF therapy in patients with a history of risk factors for malignancy.
  • Patients should undergo periodic skin examination, particularly those with risk factors for skin cancer.
  • Live vaccines should not be given concurrently with SIMPONI. Administration of vaccines to infants exposed to SIMPONI in utero is not recommended for 6 months following the mother's last SIMPONI injection during pregnancy.
  • Administration of SIMPONI is not recommended during pregnancy or breast-feeding.
  • The needle cover on the pre-filled pen or pre-filled syringe is made from dry natural rubber containing latex and may cause allergic reactions in individuals sensitive to latex.
  • Patients should be instructed how to self-inject, and to retain the Patient Alert Card included within the SIMPONI packaging which contains relevant safety information and a record of the patient's TB screening.

References:

  1. SIMPONI® (golimumab) Patient Information Leaflet. Available from: https://www.medicines.org.uk/emc/medicine/23765 and https://www.medicines.org.uk/emc/medicine/28319.