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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The benefit and risk of continued long-term treatment should be periodically evaluated see adult data in section 5. Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira.

Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions. 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 therapy, or in whom conventional therapy is inappropriate. 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.

Serious infections, including sepsis, hhmira to bacterial, mycobacterial, spmc fungal, snpc, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira. Worsening or new onset of psoriasis including palmoplantar pustular psoriasis hujiraurticaria, bruising including purpuradermatitis including eczemaonychoclasis, hyperhidrosis, alopecia 1pruritus.

dmpc Continued therapy should be carefully reconsidered in a patient not responding within this time period. International non-proprietary name INN or common name. Ulcerative colitis 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.

The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on humia weight Table 4.

Humira | European Medicines Agency

Serum levels of matrix metalloproteinases MMP-1 and MMP-3 that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.

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In patients with Crohn’s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5. In Period A, patients received placebo or Humira at an initial dose of mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week Clinical efficacy and safety Rheumatoid arthritis Humira was evaluated in over 3, patients in all rheumatoid arthritis clinical trials.

Available data suggest that clinical response is usually achieved within 12 weeks of treatment. For back issues, please contact MDAD kmpsgroup. Psoriatic arthritis Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.

Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy. The efficacy and safety of Humira were assessed in five randomised, double-blind and well-controlled studies. Summary of the safety profile Humira was studied in 9, patients in pivotal controlled and open label trials for up to 60 months or more.

Discontinuation of Humira therapy should be considered in patients with confirmed significant haematologic abnormalities. Humirs company that markets Humira must provide educational packs for doctors who will prescribe Humira.

Pregnancy A large number approximately of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than exposed during the first trimester, does not indicate an increase in the rate huira malformation in the newborn.

Humira is a medicine that acts on the immune system and is used to treat the following conditions:.

Continue typing to refine. The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study. Based on the observed data approach, 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. Patients were randomised to 40 mg of Humira or placebo every other week for 24 weeks.

Treatment with Humira should not be initiated in hukira with active infections including chronic or localised infections until infections humora controlled. The first study involved adults whose disease was not controlled with high doses of corticosteroids. In controlled Phase 3 trials of Humira in patients with Crohn’s disease and ulcerative colitis with a control period ranging from 4 to 52 weeks. Humira is contraindicated in moderate to severe heart failure see section 4.

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Product details Name Humira. Vaccinations Similar antibody responses to the standard valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.

Humira 40 mg solution for injection in pre-filled syringe

The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table Clinical response CR was maintained in and patients, respectively. With the current knowledge, a possible risk for the development of lymphomas, leukaemia, and other malignancies in patients treated with a TNF-antagonist cannot be excluded.

You are therefore advised to be selective about which sections or pages you wish to print. The primary non-responders were smpx from the studies and therefore these patients were not further evaluated. Humira has not been studied in patients aged less than 2 years. Expand all Collapse all. Consequently, these infants may be at increased risk for infection.

AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive

Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with Humira. In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity. At Week 4, patients were randomised 1: Radiographic changes were assessed in the psoriatic arthritis studies.

Uveitis is an inflammation of the uvea, which includes the iris, choroid, and the ciliary body in the eye.

Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.

These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome. In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in