SIMPONI Precautions for Use

For complete Prescribing and Safety Information please refer to the Summary of Product Characteristics for SIMPONI.¹

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)
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:	Thrombocytopenia, pancytopenia
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.

References

1. SIMPONI Summary of Product Characteristics.
   https://www.medicines.ie/medicines/simponi-50-mg solution-for-injection-pre filled-syringe-33740/spc
2. SIMPONI Patient Reminder Card.
   https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/simponi_hcp_important-safety-information.pdf?