HUMIRA SMPC PDF

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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A similar safety profile was observed during retreatment as before withdrawal. In Period A, patients received placebo or Humira at an initial dose of mg at Week 0 and 80 mg at Week 2 and 40 mg every week starting at Week 4 to Week The study in younger children aged 2 to 4 years showed that the majority of children responded well to Humira treatment and this response was maintained after 24 weeks.

In the open-label extension, improvement in the humora and symptoms was maintained with Humira therapy through Week In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone.

Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.

They were followed for up to two years after randomization. Infections Patients taking TNF-antagonists are more susceptible to serious infections. Surgery There is limited safety experience of surgical procedures in patients treated with Humira. Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. The syringe inside the pen is made from type 1 glass with a plunger stopper bromobutyl rubber and a needle with a needle shield thermoplastic elastomer.

Top Articles Annual Report: Most ALT elevations occurred with concomitant methotrexate use. Ear and labyrinth disorders. Patients continued the trial regimen until treatment failure or until 18 months had elapsed. Posology Rheumatoid arthritis 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.

Humira 40 mg solution for injection in pre-filled syringe

Last updated March 31, Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period. Beyond 16 weeks, patients with empc 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.

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A marketing authorization decision is anticipated by September. After Week 2, patients in both adalimumab arms received 40 mg eow. Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.

The median time to treatment failure was Humira 40 mg eow. There were three groups in this study. Humira 40 mg solution for injection in pre-filled syringe Each 0. 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.

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 see sections 5. 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 every other week as a single dose via subcutaneous injection.

To email a medicine you must sign up and log in. 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.

Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with Humira, out of which 37 Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.

Table 25 Maintenance regimen.

For practical information about using Humira, patients should read the humora leaflet or contact their doctor or pharmacist. Patients in rheumatoid arthritis studies I, II and III were tested at multiple time points for anti-adalimumab antibodies during the 6 to 12 month period.

Haematologic reactions Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. After treatment with Humira, a rapid decrease in levels of acute phase reactants of inflammation C-reactive protein CRP and erythrocyte sedimentation rate ESR and hmuira cytokines IL-6 was observed, compared to baseline in patients with rheumatoid arthritis.

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Pulmonary embolism 1interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion 1. In a prospective cohort registry, women with rheumatoid arthritis RA or Crohn’s disease CD treated with adalimumab at least during the first trimester and women with RA or CD not treated with adalimumab were enrolled.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:. 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.

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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Hepatic or renal impairment Humira has not been studied in patients with hepatic or renal impairment. In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients. Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard Each 0.

Mannitol Polysorbate 80 Water for injections. Maintenance of remission and response rates are presented in Table Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week Patients taking TNF-antagonists are more susceptible to serious infections.

Patients were randomised to 40 mg of Humira or placebo every other week for 24 weeks. Administration of live vaccines e. Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab see section 4. In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

Uveitis associated with juvenile idiopathic arthritis. Hypersensitivity, allergies including seasonal allergy.