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Safety Information

SIMPONI® 50 mg Prescribing Information Great Britain / Northern Ireland [External links]
SIMPONI® 100 mg Prescribing Information Great Britain / Northern Ireland [External links]

SIMPONI® (golimumab) Selected Safety Information

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

Contraindications: Do not use in patients with active tuberculosis, 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.

Special warnings and precautions for use:

  • Monitor patients closely for infections, including active and latent TB, before, during and five months after treatment. Patients should be tested for Hepatitis B infection before initiating treatment.
  • Concurrent use with live vaccines with SIMPONI is not recommended.
  • Anti-TNFs have also been associated with malignancies, leukaemia 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.
  • Screen for dysplasia in all patients with UC who are at increased risk or had a prior history for dysplasia or colon carcinoma; assessing carefully assess the risks and benefits of continued treatment with SIMPONI in newly diagnosed dysplasia patients.
  • Patients should undergo periodic skin examination, particularly those with risk factors for skin cancer.
  • Use of TNF-blocking agents, including SIMPONI, have been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders including multiple sclerosis and peripheral demyelinating disorders, treatment discontinuation with SIMPONI is to be considered.
  • Closely monitor patients for infections if surgery is required.
  • SIMPONI should be used with caution in patients with impaired hepatic function.
  • Particular attention should be paid to infections when treating the elderly. SIMPONI contains sorbitol (E420), use with caution in patients with rare hereditary problems of fructose intolerance.
  • Concomitant use with other biological therapeutics to treat the same conditions as SIMPONI, including anakinra and abatacept is not recommended.
  • Discontinue treatment with SIMPONI in patients with symptoms suggestive of a lupus-like syndrome and antibodies against double-stranded DNA are present.
  • Patients should be advised to seek medical attention if they develop signs and symptoms suggestive of blood dyscrasias
  • Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last SIMPONI treatment. Women must not breast feed for at least 6 months after SIMPONI treatment.

Most common side effects – Refer to SmPC for more information on side effects:

Very Common ≥1/10: Upper respiratory tract infection.

Summary of the safety profile1

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, 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 and 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)
Rare: Lymphoma, leukaemia, melanoma, Merkel cell carcinoma
Not known: Hepatosplenic T-cell lymphoma*, Kaposi’s sarcoma
Blood and lymphatic system disorders
Common: Leukopenia (including neutropenia), anaemia
Uncommon: Thrombocytopaenia, pancytopaenia
Rare: Aplastic anaemia, agranulocytosis
Immune system disorders
Common: Allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive
Rare: Serious systemic hypersensitivity reactions (including anaphylactic reaction), vasculitis (systemic), sarcoidosis
Endocrine disorders
Uncommon: Thyroid disorder (such as hypothyroidism, hyperthyroidism and goitre)
Metabolism and nutrition disorders
Uncommon: Blood glucose increased, lipids increased
Psychiatric disorders
Common: Depression, insomnia
Nervous system disorders
Common: Dizziness, headache, paraesthesia
Uncommon: Balance disorders
Rare: Demyelinating disorders (central and peripheral), dysguesia
Eye disorders
Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritis and irritation)
Cardiac disorders
Uncommon: Arrhythmia, ischemic coronary artery disorders
Rare: Congestive heart failure (new onset or worsening)
Vascular disorders
Common: Hypertension
Uncommon: Thrombosis (such as deep venous and aortic), flushing
Rare: Raynaud's phenomenon
Respiratory, thoracic and mediastinal disorders
Common: Asthma and related symptoms (such as wheezing and bronchial hyperactivity)
Uncommon: Interstitial lung disease
Gastrointestinal disorders
Common: Dyspepsia, gastrointestinal and abdominal pain, nausea, gastrointestinal inflammatory disorders (such as gastritis and colitis), stomatitis
Uncommon: Constipation, gastro-oesophageal reflux disease
Hepatobiliary disorders
Common: Alanine aminotransferase increased, aspartate aminotransferase increased
Uncommon: Cholelithiasis, hepatic disorders
Skin and subcutaneous tissue disorders
Common: Pruritus, rash, alopecia, dermatitis
Uncommon: Bullous skin reactions, psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria
Rare: Lichenoid reactions, skin exfoliation, vasculitis (cutaneous)
Not known: Worsening of symptoms of dermatomyositis
Musculoskeletal and connective tissue disorders
Rare: Lupus-like syndrome
Renal and urinary disorders
Rare: Bladder disorders, renal disorders
Reproductive system and breast disorders
Uncommon: Breast disorders, menstrual disorders
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
Rare: Impaired healing
Injury, poisoning and procedural complications
Common: Bone fractures

*: Observed with other TNF-blocking agents.

Throughout this section, median duration of follow-up (approximately 4 years) is generally presented for all golimumab use. Where golimumab use is described by dose, the median duration of follow-up varies (approximately 2 years for 50 mg dose, approximately 3 years for 100 mg dose) as patients may have switched between doses.


  1. SIMPONI Summary of Product Characteristics.

Supporting documentation

SIMPONI® 50 mg Prescribing Information Great Britain / Northern Ireland
SIMPONI® 100 mg Prescribing Information Great Britain / Northern Ireland

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GB-GOL-00525 | Date of Preparation: November 2020