Humira

Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. 4). Patients treated with Humira should be given the Patient Reminder Card.

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

Posology Paediatric population Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).

Humira is administered every other week via subcutaneous injection. Table 1. Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight Dosing Regimen 10 kg to < 30 kg 20 mg every other week ≥ 30 kg 40 mg every other week Available data suggest that 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. There is no relevant use of Humira in patients aged less than 2 years for this indication. Humira may be available in other strengths and/or presentations depending on the individual treatment needs.

Enthesitis-related arthritis 4 The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). Humira is administered every other week via subcutaneous injection. Table 2.

Humira Dose for Patients with Enthesitis-Related Arthritis Patient Weight Dosing Regimen 15 kg to < 30 kg 20 mg every other week ≥ 30 kg 40 mg every other week Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric plaque psoriasis The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).

Humira is administered via subcutaneous injection. Table 3. Humira Dose for Paediatric Patients with Plaque Psoriasis Patient Weight Dosing Regimen 15 kg to < 30 kg Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose ≥ 30 kg Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.

If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed. The safety of Humira in paediatric patients with plaque psoriasis has been assessed for a mean of 13 months. There is no relevant use of Humira in children aged less than 4 years for this indication.

Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric Crohn's disease The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight (Table 4).

Humira is administered via subcutaneous injection. 5 Table 4. Humira Dose for Paediatric Patients with Crohn’s disease Patient Weight Induction Dose Maintenance Dose Starting at Week 4 < 40 kg • 40 mg at week 0 and 20 mg at week 2 In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: • 80 mg at week 0 and 40 mg at week 2 20 mg every other week ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2 In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used: • 160 mg at week 0 and 80 mg at week 2 40 mg every other week Patients who experience insufficient response may benefit from an increase in dosage: • < 40 kg: 20 mg every week • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.

There is no relevant use of Humira in children aged less than 6 years for this indication. Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Paediatric Uveitis The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).

Humira is administered via subcutaneous injection. In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate. Table 5. Humira Dose for Paediatric Patients with Uveitis Patient Weight Dosing Regimen < 30 kg 20 mg every other week in combination with methotrexate ≥ 30 kg 40 mg every other week in combination with methotrexate When Humira therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.

2). 6 There is no relevant use of Humira in children aged less than 2 years in this indication. 1). Humira may be available in other strengths and/or presentations depending on the individual treatment needs. Renal and/or hepatic impairment Humira has not been studied in these patient populations.

No dose recommendations can be made. Method of […]

Summary of the safety profile Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more. These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.

The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period. 4% for control treated patients. 13 The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.

Serious adverse reactions have been reported for Humira. TNF-antagonists, such as Humira affect the immune system and their use may affect the body’s defence against infection and cancer. Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of Humira.

Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.

Paediatric population In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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); and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The highest frequency seen among the various indications has been included. 8. g. optic neuritis, Guillain-Barré syndrome) 1) Eye disorders Common Visual impairment, conjunctivitis, blepharitis, eye swelling Uncommon Diplopia Ear and labyrinth disorders Common Vertigo Uncommon Deafness, tinnitus 16 System Organ Class Frequency Adverse Reaction Cardiac disorders* Common Tachycardia Uncommon Myocardial infarction1), arrhythmia, congestive heart failure Rare Cardiac arrest Vascular disorders Common Hypertension, flushing, haematoma Uncommon Aortic aneurysm, vascular arterial occlusion, thrombophlebitis Respiratory, thoracic and mediastinal disorders* Common Asthma, dyspnoea, cough Uncommon Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1) Rare Pulmonary fibrosis1) Gastrointestinal disorders Very common Abdominal pain, […]

Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Patients taking TNF -antagonists are more susceptible to serious infections.

Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period.

Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Other opportunistic infections).

Patients who develop a new infection while undergoing treatment with Humira should be monitored closely and undergo a complete diagnostic evaluation. Administration of Humira 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.

Physicians should exercise caution when considering the use of Humira 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.

7 Serious infections Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira.

Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalisation or fatal outcomes associated with infections have been reported. Tuberculosis Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira.

e. disseminated) tuberculosis. Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people 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). It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.

3). In all situations described below, the benefit/risk balance of therapy should be very carefully considered. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Humira and in accordance with local recommendations.

Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Humira in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira. Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Humira.

, persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Humira. Other opportunistic infections Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.

These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes. 8 For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Humira should be promptly discontinued.

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. e. surface antigen positive). Some cases have had a fatal outcome.

Patients should be tested for HBV infection before initiating treatment with Humira. For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.

Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. […]

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