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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Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira. Expand all Collapse all.

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

More than twenty main studies involving over 9, patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions. No malignancies were observed in 60 paediatric patients with an exposure of The results for the 40 mg every other week dose are summarised in Table 7. Aortic aneurysm, huira arterial occlusion, thrombophlebitis. Hypersensitivity, allergies including seasonal allergy. Serious allergic reactions associated with Humira were rare during clinical trials.

In empc than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. 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.

Marketing authorisation number s 9. There is no apparent correlation between the presence of anti-adalimumab antibodies and the occurrence of adverse events.

Hepatitis reactivation of hepatitis B 1 autoimmune hepatitis 1. There is no relevant use of Humira in children aged less than 4 years for this indication.

It is recommended that the conduct and results of these tests are recorded in the Patient Reminder Card. 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 of malformation in the newborn.

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In post-marketing experience from January to Decemberpredominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2. Reports included cases of pulmonary and extra-pulmonary i. Appropriate screening tests i. View all 13 ratings. The primary endpoint was the time to treatment failure, defined according to multiple components of intraocular inflammation that was based on smmpc Standardization of Uveitis Nomenclature SUN criteria.

Approximately half the cases were lymphomas. 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. In patients who develop HBV reactivation, Humira should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

Humira 40 mg solution for injection in pre-filled syringe Each 0. Some cases have had a fatal outcome. Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.

Fewer patients receiving Humira with methotrexate developed antibodies against Humira which can reduce its effectsso the results found that the use of Humira with methotrexate was more effective than Humira used alone.

Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II. Humira 40 mg solution for injection in pre-filled syringe with automatic needle guard Each 0.

Humira 40 mg solution for injection in pre-filled syringe

Abdominal pain, nausea and vomiting. Injection site reactions generally did not necessitate discontinuation of the medicinal product. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias e. During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.

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In study UC-II, patients received mg of Humira at Week 0, 80 mg at Week 2 and 40 mg eow thereafter, and patients hummira placebo. Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira. Humira 40 mg Weekly. Ulcerative colitis Uumira 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.

At 8 years, 81 of patients originally treated with 40 mg Humira every other week were evaluated radiographically.

Humira | European Medicines Agency

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, hymira suppurativa and uveitis patients.

Rare postmarketing cases of hepatosplenic T-cell lymphoma have been identified in patients treated with adalimumab. For practical information about using Humira, patients should read the package leaflet or humifa their doctor or pharmacist. Patients should be tested for HBV infection before initiating treatment with Humira.