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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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. 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.
Below is a brief description humra the studies and their results: Fatal and life-threatening infections including sepsis, opportunistic infections and TBHBV reactivation and various malignancies including leukaemia, lymphoma and HSTCL have also been reported with use of Humira.
Date of first authorisation: Thus additional caution should be exercised in considering Humira treatment of these patients see section 4.
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.
Paediatric population Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis from 2 years of age Smpv recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight Table 1. RA study III also had a smpf endpoint of changes in quality of life. Available data suggest that Humira does not worsen or cause strictures.
Accessed July 13,  Ramanan, A. 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.
The benefit and risk of continued long-term treatment should be periodically humlra see adult data in section 5. Detailed information on this medicinal product is available on the website of the European Medicines Agency http: First medicine recommended for approval for hidradenitis suppurativa. For the full list of all side effects reported with Humira, see the package leaflet.
The review of the marketing authorization application MAA is being conducted under the centralized licensing procedure. Congestive heart failure In a clinical trial with another TNF-antagonist worsening congestive heart failure and hu,ira mortality due to congestive heart failure have been observed.
Revised SPC: Humira (adalimumab) Pre-filled Pen, Pre-filled Syringe and Vial –
In study UC-II, patients received mg of Humira at Week 0, 80 mg at Week 2 and 40 mg eow thereafter, and patients received placebo. However, the occurrence was rare. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary humirx. Vertigo and visual impairment may occur following administration of Humira see section 4. 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.
There is insufficient evidence of the efficacy of Humira in patients with ankylosing spondylitis-like psoriatic arthropathy due to the xmpc number of patients studied. Paediatric Uveitis 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.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists. Serum levels of matrix metalloproteinases MMP-1 and MMP-3 that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration. In order to improve traceability of biological medicinal products, the nameand the batch number of the administered product should be clearly recorded.
AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive
Taking these results into consideration, Humira is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate see section 4. The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional weeks. Failure to respond to treatment for Crohn’s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Sarcoidosis 1vasculitis. All subjects received open-label induction therapy at a dose based on their Baseline body weight: The recommended adolescent HS dosing schedule is 40 mg every other week.
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.
If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed. A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken. International non-proprietary name INN or common name.
For practical information about using Humira, patients should read the package leaflet or contact their doctor or pharmacist. Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with Humira versus patients receiving placebo See Table Patients continued the trial regimen until treatment failure or until 18 months had elapsed.
Humira 40 mg solution for injection in pre-filled syringe
Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been smlc cases of serious infections and blood cancers in patients using Humira. Among those, 64 patients Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira see section 4.
In patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years, anti-adalimumab antibodies were identified in