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Safety Information
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.
Reference
- SIMPONI Summary of Product Characteristics.
Supporting documentation
SIMPONI 50 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Syringe | Patient Information Leaflet for Pre-filled Pen
SIMPONI 100 mg
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet for Pre-filled Pen
GB-GOL-00525 | Date of Preparation: November 2020