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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By continuing to browse the site you are agreeing to our policy on the use of cookies. Patients received placebo, an initial dose of MTX 7. The first received placebo injections every week for 52 weeks.

Appropriate screening tests i.

Humira, when used as directed, has been shown in clinical trials to be effective at reducing important humria of each of the conditions for which it is approved. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4. Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings. Concomitant antibiotic use was not allowed during the study.

Surgery There is limited safety experience of surgical procedures in patients treated with Humira. Most Recent Most Recent.

Humira 40 mg solution for injection in pre-filled syringe

Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the Humira group experienced worsening of abscesses Please refer to the product information document. None of these patients experienced rebound during the withdrawal period.

All subjects received open-label induction therapy at a dose based on their Baseline body weight: The benefit and risk of continued long-term treatment should be periodically evaluated see section 5.

Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Humira. Hypersensitivity, allergies including seasonal allergy.

Humira | European Medicines Agency

ssmpc Erythema multiforme 1Stevens-Johnson syndrome 1angioedema 1cutaneous vasculitis 1 lichenoid skin reaction 1. In this multicenter, double-masked, randomized, placebo-controlled trial, researchers assessed the efficacy and safety of HUMIRA in children and adolescents two years of age or older who had active JIA-associated uveitis.

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For the full list of all side effects reported with Humira, see the package leaflet. Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira. In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Patients who were taking a stable dose of methotrexate were randomly assigned in a 2: In controlled trials of Humira initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 in adult patients with uveitis up to 80 weeks with a median exposure of No malignancies were observed in 77 paediatric patients with an exposure of Injection site reactions generally did not necessitate discontinuation of the medicinal product.

Autoimmune processes Treatment with Humira may result in the formation of humita antibodies.

In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone. Some rare but serious side effects have been reported, mspc serious infections. Use of anti-tuberculosis prophylaxis treatment should humir 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 humkra active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Expand all Collapse all. Hukira 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. Humira is administered via subcutaneous injection. Patients were then re-treated with adalimumab 0. Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy. Hepatosplenic T-cell lymphoma 1 Merkel cell carcinoma neuroendocrine carcinoma of the skin 1.

GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome. The combination of Humira and anakinra is not recommended see section 4.

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AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Corticosteroid taper was permitted after Week 8. It is not intended to provide practical advice on how to use Humira.

At Humirx 16, more patients randomised to Humira 0. Continued therapy should be carefully reconsidered in a patient not responding within this time period. Uveitis 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.

Some of those had a fatal outcome. Patients received an initial dose of 80 mg Humira followed by 40 mg every other week starting one week after the initial dose or placebo for 16 weeks.

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 ASpsoriatic arthritis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.

The adjusted OR accounting for baseline differences was 1. The European Medicines Agency concluded that benefits of Humira outweigh its risks and recommended that it be given marketing authorisation. The most common side effects with Humira seen in more than 1 patient in 10 are infections including in the nose, throat and sinusesinjection site reactions redness, itching, bleeding, pain or swellingheadache and muscle and bone pain.

Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity, and genotoxicity. The recommended dose of Humira for paediatric patients with uveitis from 2 years of age is based on body weight Table 5. Humira may have a minor influence on the ability to drive and use machines.