For complete Prescribing and Safety Information please refer to the Summary of Product Characteristics for SIMPONI.1
SIMPONI® (golimumab) should not be used in patients with active tuberculosis (TB), other severe infections, moderate/severe heart failure (NYHA class III/IV) or in patients with a history of hypersensitivity to SIMPONI or to any of the excipients.
Patients should be tested for both active and inactive (‘latent’) TB before initiating treatment with SIMPONI. For patients who test positive, consultation with a physician with expertise in the treatment of TB is recommended.
Patients should be tested for hepatitis B virus (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.
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.
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. If anaphylactic reaction or other serious allergic reactions occur, administration of golimumab should be discontinued immediately and appropriate therapy initiated.
Anti-TNFs have been associated with malignancies and lymphomas including hepatosplenic T-cell lymphoma (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.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of Simponi. Discontinuation of Simponi should be considered if these disorders develop.
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bleeding pallor). Discontinuation of Simponi should be considered in patients with confirmed significant hematologic abnormalities.
Live vaccines or therapeutic infectious agents should not be given concurrently with SIMPONI. Administration of live 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 breastfeeding.
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 Reminder Card2, included within the SIMPONI packaging, which contains relevant safety information.
For complete Prescribing and Safety Information please refer to the Summary of Product Characteristics for SIMPONI.1
In the controlled period of the pivotal trials in RA, PsA, AS, nr-Axial SpA, and UC, upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in 12.6% of golimumab-treated patients compared with 11.0% of control patients. The most serious ADRs that have been reported for golimumab include serious infections (including sepsis, pneumonia, TB, invasive fungal and opportunistic infections), demyelinating disorders, HBV reactivation, congestive heart failure (CHF), autoimmune processes (lupus-like syndrome), haematologic reactions, serious systemic hypersensitivity (including anaphylactic reaction), vasculitis, lymphoma and leukaemia.
Adverse events occurring in patients treated with SIMPONI across clinical trials and post marketing reporting1
ADRs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in the table below. Within the designated system organ classes, the adverse drug reactions are listed under headings of frequency and using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Tabulated list of Adverse Reactions1
Infections & Infestations
Very common:
Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis)
Common:
Bacterial infections (such as cellulitis), lower respiratory tract infection (such as pneumonia), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections, abscess
Uncommon:
Sepsis including septic shock, pyelonephritis
Rare:
Tuberculosis, opportunistic infections (such as invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), hepatitis B reactivation, bacterial arthritis, infective bursitis
Neoplasms, benign, malignant and unspecified
Uncommon:
Neoplasms (such as skin cancer, squamous cell carcinoma and melanocytic naevus)
General disorders and administration site conditions
Common:
Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort
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