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Important Safety Information

Updated on 24/04/2018

IMMUNOLOGY
SIMPONI indications

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)
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
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: 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

  1. 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

MULT-1246520-00001 | Date of Preparation: April 2018