ROLE_ANONYMOUS
Important Safety Information
Updated on 11/02/2019
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 III/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.
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* |
| 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: | Skin exfoliation, vasculitis (cutaneous) |
| 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-NON-00378 | Date of Preparation: February 2019