Patients who develop a new infection while undergoing treatment with Humira should be monitored closely. Administration of Humira should be discontinued if a. HIGHLIGHTS OF PRESCRIBING INFORMATION. These highlights do not include all the information needed to use. HUMIRA safely and effectively. See full. HUMIRA safely and effectively. See full prescribing information for. HUMIRA. HUMIRA (adalimumab) injection, for subcutaneous use. Initial U.S. Approval:

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Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Humira has been shown to reduce the rate of progression of joint sm;c as measured by X-ray and to improve physical function, when given in combination with methotrexate. Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs DMARDs.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate for the efficacy in monotherapy see section 5. Humira has not been studied in patients aged less than 2 years. Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy see section 5.

Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Humira is indicated himira the smpx of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.

Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease see Section 5. Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates hymira systemic therapy.

Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa acne inversa in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy bumira sections 5.

Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine 6-MP or azathioprine AZAor who are intolerant to or have medical contraindications for such therapies. Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional smpv, or in whom conventional therapy is inappropriate. Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated.

Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira see section 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. During treatment with Humira, other concomitant therapies e. The recommended dose of Humira 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 Humira. Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during hhumira with Humira.

Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4. In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.

Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.

Continued therapy should be reconsidered in a patient not responding within this time period. There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of Humira after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.

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Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis.

The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered sm;c other week as a single dose via subcutaneous injection.

The recommended smpd of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose. Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.

Revised SPC: Humira (adalimumab) Pre-filled Pen, Pre-filled Syringe and Vial –

Beyond 16 weeks, patients with inadequate response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage see section 5.

If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week. The recommended Humira dose regimen for adult patients with hidradenitis suppurativa HS is mg initially at Day 1 given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive daysfollowed by 80 mg two weeks later at Day 15 given as two 40 mg injections in one day. Two weeks later Day 29 continue with a dose of 40 mg every week or 80 mg every other week given as two 40 mg injections in one day.

Antibiotics may be continued during treatment with Humira if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be re-introduced see section 5. The benefit and risk of continued long-term treatment should be periodically evaluated see section 5.

The recommended Humira induction dose regimen for adult patients with moderately to severely active 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 mg at Week 0 given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days80 mg at Week 2 given as two 40 mg injections in one daycan 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 Humira and signs and symptoms of disease recur, Humira may be re-administered.

There is little experience from re-administration after more than 8 weeks since the previous dose. During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Some patients who experience decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week. Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week Continued therapy should be carefully reconsidered in a patient not responding within this time period. The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is mg at Week 0 given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days and 80 mg at Week 2 given as two 40 mg injections in one day.

Some patients who experience decrease in their response to 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week. Available data suggest that clinical response is usually achieved within weeks of treatment.

Humira therapy should not be continued in patients failing to respond within this time period. The recommended dose of Humira for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with Humira alone. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.

It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis see section 5. 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.

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Available data suggest that clinical response is usually achieved within 12 weeks of treatment. The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight Table 2. Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.

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.

Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose. 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.

Humira 40 mg solution for injection in pre-filled syringe

If retreatment with Humira is indicated, the above guidance smoc 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 are no clinical trials with Humira in adolescent patients with HS. The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation see section 5.

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The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection. In adolescent patients with inadequate response to Humira 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.

The benefit and risk of continued long-term treatment should be periodically evaluated see adult data in section 5. 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.

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:.

The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight Table 5. In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate. The safety and efficacy of Humira in children aged years have not yet been established.

No data are available. There is no relevant use of Humira in children aged less than 4 years for this indication. Psoriatic arthritis and axial spondyloarthritis including ankylosing spondyliti s.

There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis. Humira is administered by subcutaneous injection. Full instructions for use are provided in the package leaflet. Active tuberculosis or other severe infections such as sepsis, and opportunistic infections see section 4.

In order to improve traceability of biological medicinal products, the nameand the batch number of the administered product should be clearly recorded. 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.

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