Simponi

Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated. Patients treated with Simponi should be given the Patient Card which is included in the pack.

45 mL pre-filled pen is for paediatric patients. Each pre-filled pen is for single use in a single patient, and should be discarded immediately after use. 3 Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m2 body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month.

The prescribed volume of injection should be selected according to patient’s height and weight as shown in Table 1. 4 Polyarticular juvenile idiopathic arthritis in children with a body weight of at least 40 kg For children with body weight of at least 40 kg, a 50 mg pre-filled pen or pre-filled syringe is available.

2 of the Simponi 50 mg pre-filled pen or pre-filled syringe SmPC. Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.

Ulcerative colitis Paediatric ulcerative colitis (pUC) in children 2 years of age and older with a body weight of at least 15 kg The recommended dose of Simponi for patients from 2 to 17 years of age with ulcerative colitis is based on body weight.

For patients with body weight of at least 15 kg to less than 40 kg who are in remission at or after week 54, the physician may consider decreasing the maintenance dose to 25 mg every 4 weeks. To administer this dose, the 45 mg pre-filled pen is available.

25 mL For induction and maintenance treatment a 50 mg pre-filled syringe or 100 mg pre-filled syringe is available. 2 of the Simponi 50 mg or 100 mg pre-filled syringe SmPC. Missed dose If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers.

Patients should be instructed not to inject a double dose to make up for the forgotten dose. The next dose should be administered based on the following guidance: 4  if the dose is less than 2 weeks late, the patient should inject the forgotten dose and stay on the original schedule.

0% of control patients. 4). Tabulated list of adverse reactions ARs observed in clinical studies and reported from world-wide post-marketing use of golimumab are listed in Table 2. Within the designated system organ classes, the ARs 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.

Table 2 Tabulated list of ARs 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 11 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), dysgeusia Eye disorders Uncommon: Visual disorders (such as blurred vision and decreased visual acuity), conjunctivitis, eye allergy (such as pruritus and irritation) Cardiac disorders Uncommon: Arrhythmia, ischaemic 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 12 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.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab.

Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. 3). Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection.

Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving golimumab.

Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with golimumab should be monitored closely and undergo a complete diagnostic evaluation.

Administration of golimumab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. 5 For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of golimumab treatment should be carefully considered before initiation of golimumab therapy.

In at-risk patients treated with golimumab, an invasive fungal infection should be suspected if they develop a serious systemic illness. Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections, if feasible.

1. 4). 4).