The Humira pre-filled pen is a single-use grey and plum-coloured pen which contains a glass syringe with Humira. Following the subcutaneous administration of body weight-based dosing of 0.6 mg/kg (maximum of 40 mg) every other week to paediatric patients with ulcerative colitis, the mean trough steady-state serum adalimumab concentration was 5.01±3.28 µg/ml at Week 52. Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively). At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy. Your results will vary based on your condition being treated and other factors, such as tolerability to treatment and other medications you may be using. If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions on your skin. 0074-4339-06, Available via Click & Collect. • 1 pre-filled pen (0.4 ml sterile solution), with 2 alcohol pads in a blister. ₹ 18,000/ Number Get Latest Price. Study PsA-I enrolled 313 adult patients with moderately to severely active PsA (>3 swollen and >3 tender joints) who had an inadequate response to NSAID therapy in one of the following forms: (1) distal interphalangeal (DIP) involvement (N=23); (2) polyarticular arthritis (absence of rheumatoid nodules and presence of plaque psoriasis) (N=210); (3) arthritis mutilans (N=1); (4) asymmetric PsA (N=77); or (5) AS-like (N=2). After that, a maintenance dose of 40 mg was administered every other week. You can call your doctor or 1-800-4HUMIRA (1-800-448-6472) if you have any questions about giving yourself an injection. The safety profile for patients with PsA and AS treated with HUMIRA 40 mg every other week was similar to the safety profile seen in patients with RA, HUMIRA Studies RA-I through IV. 0074-0243-02, Manufacturer: Cipla. Additionally, in Study Ps-I, subjects on HUMIRA who maintained a PASI 75 were re-randomized to HUMIRA (N = 250) or placebo (N = 240) at Week 33. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. 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Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Humira, especially: certolizumab, golimumab, infliximab, rituximab. Files, All Mapping For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Humira should be promptly discontinued. 53/58, Kutty Gramani Street, Raja Annamalai Puram, Chennai - 600028, Dist. Refrigerated HUMIRA may be used until the expiration date printed on the HUMIRA carton, dose tray or prefilled syringe. Continued therapy should be carefully reconsidered in a patient not responding within this time period. Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells. a. p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. E SINGLE-DOSE PREFILLED SYRINGE CONTAINS: All Drug In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of 0.05 per 100 patient-years. 21. 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 5.1 and 5.2). There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.