Trudexa

Trudexa treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or Crohn’s disease. Patients treated with Trudexa should be given the special alert card.

After proper training in injection technique, patients may self-inject with Trudexa if their physician determines that it is appropriate and with medical follow-up as necessary. , corticosteroids and/or immunomodulatory agents) should be optimised.

Adults Rheumatoid arthritis The recommended dose of Trudexa for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Trudexa.

Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Trudexa. 1. In monotherapy, some patients who experience a decrease in their response may benefit from an increase in dose intensity to 40 mg adalimumab every week.

Psoriatic arthritis and ankylosing spondylitis The recommended dose of Trudexa for patients with psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.

For all of the above indications, available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.

Crohn’s disease The recommended Trudexa induction dose regimen for adult patients with severe Crohn’s disease is 80 mg at week 0 followed by 40 mg at week 2. In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction.

After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection. Alternatively, if a patient has stopped Trudexa and signs and symptoms of disease recur, Trudexa may be re-administered. There is little experience from re-administration after more than 8 weeks since the previous dose.

Clinical Trials Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months. These trials included rheumatoid arthritis patients with short term and long standing disease as well as psoriatic arthritis, ankylosing spondylitis and Crohn’s disease patients.

1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period. 3% for control treated patients. Adverse events at least possibly causally-related to adalimumab for Studies I− IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common≥ 1/100 < 1/10; uncommon≥ 1/1000 to ≤ 1/100) and rare < 1/1000 in Table 1 below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1 Undesirable Effects in Clinical Studies System Organ Class Frequency Adverse Reaction Infections and infestations Common lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection Uncommon opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot) Rare necrotising fasciitis, viral meningitis, diverticulitis Uncommon skin papillomaNeoplasms benign and malignant (including cysts and polyps) Rare lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin Medicinal Product no longer authorised9 Common lymphopaenia Uncommon neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, , lymphadenopathy, leucocytosis Blood and the lymphatic system disorders Rare pancytopaenia, idiopathic thrombocytopaenia purpura Uncommon systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy Immune system disorders Rare serum sickness Endocrine disorders Rare thyroid disorder (including goitre) Uncommon Hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia Metabolism and nutrition disorders Rare hypercalcaemia Psychiatric disorders Uncommon mood disorders, anxiety (including nervousness and agitation) Common dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias) Uncommon syncope, migraine, tremor, sleep disturbances Nervous system disorders Rare multiple sclerosis Common infection, irritation or inflammation of the eye Uncommon vision disorder, ocular sensation disorders Eye disorders Rare Panophthalmitis, iritis, glaucoma Uncommon tinnitus, ear discomfort (including pain and swelling) Ear and labyrinth disorders Rare hearing loss Uncommon arrhythmias, tachycardia, palpitationsCardiac disorders Rare cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion Vascular disorders Uncommon hypertension, flushing, haematoma Rare vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm Respiratory, thoracic and mediastinal disorders Common cough, nasopharyngeal pain Medicinal Product no longer authorised10 Uncommon asthma, dyspnoea, dysphonia, nasal congestion Rare pulmonary oedema, pharyngeal oedema, pleural effusion, pleurisy Common diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea Uncommon rectal haemorrhage, gastritis, vomiting, dyspepsia, abdominal bloating, constipation, Gastrointestinal disorders Rare intestinal stenosis, colitis, enteritis, oesophagitis Hepato-biliary disorders Common hepatic enzymes increased Rare hepatic necrosis, hepatitis Common rash, dermatitis and eczema, pruritus, hair loss Uncommon urticaria, psoriasis, ecchymosis and increased bruising, purpura Skin and subcutaneous tissue disorders Rare erythema multiforme, panniculitis Common musculoskeletal painMusculoskeletal, connective tissue and bone disorders Rare rhabdomyolysis Uncommon haematuria, renal impairment, bladder and urethral symptoms Renal and urinary disorders Rare proteinuria, renal pain Reproductive system and breast disorders Uncommon menstrual cycle and uterine bleeding disorders Very Common injection site reaction (including pain, swelling, redness or pruritus) Common pyrexia, fatigue (including asthenia and malaise) General disorders and administration site conditions Uncommon chest pain, oedema, influenza like illness Investigations Uncommon blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present Injury and poisoning Uncommon accidental injury, impaired healing Injection site reactions Medicinal Product no longer authorised11 In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.

Infections Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with Trudexa. Because the elimination of adalimumab may take up to five months, monitoring should be continued throughout this period.

Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. Patients who develop a new infection while undergoing treatment with Trudexa should be monitored closely.

Administration of Trudexa should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering the use of Trudexa in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.

Serious infections, sepsis, tuberculosis and other opportunistic infections, including fatalities, have been reported with Trudexa.

Serious infections:

In clinical trials an increased risk of serious infections in patients receiving Trudexa has been shown, and reports from the post-marketing setting support this finding. Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia.

Tuberculosis:

There have been reports of tuberculosis in patients receiving Trudexa. e. disseminated. Medicinal Product no longer authorised5 Before initiation of therapy with Trudexa, all patients must be evaluated for both active or inactive (latent) tuberculosis infection.

This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/or current immunosuppressive therapy. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).

Hypersensitivity to the active substance or to any of the excipients. 4). 4).