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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In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:. Clinical results were assessed for induction of remission at Week 8 and for maintenance of remission at Week By Week 68, patients receiving continuous Humira treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study Table Of the remaining patients, evaluable patients reached 78 weeks of open-label adalimumab treatment.
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. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.
AbbVie Receives CHMP Positive Opinion for Humira | PharmaLive
A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded see section 4. Abdominal pain, nausea and vomiting. Cases of worsening congestive humita failure have also been reported in patients receiving Humira.
The syringe or pen must be protected from light, and discarded if not used within the day period.
Humira | European Medicines Agency
Huumira recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without humora evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. In hkmira pivotal controlled trials in adults and children, Most patients continued on Humira after the infection resolved. Patients treated with Humira had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection. 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 must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure an inability of the heart to pump enough blood around the body.
The primary efficacy endpoint was the proportion of patients with no flare by Week 68 of the study. To view the changes to a medicine you must sign up and log in.
A greater proportion of patients on Humira had no disease flare during the double-blind period, when compared with those on placebo Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission. Adalimumab should only be used during pregnancy if clearly needed.
Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira. These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Consequently, Smpx can be used during breastfeeding. At 10 years, 79 of patients originally treated with 40 mg Humira every other week were evaluated radiographically.
The recommended dose of Humira for patients with Crohn’s disease from 6 to 17 years of age is based on body weight Table 4.
To bookmark a medicine you must sign up and log in. The review of the marketing authorization application MAA is being conducted under the centralized licensing procedure. In the larger AS study I with patients, results showed statistically significant improvement of the signs and smcp of ankylosing spondylitis in patients treated with Humira compared to placebo.
Knollstrasse Ludwigshafen Germany. The safety profile for patients with HS treated with Humira weekly was consistent with the known safety profile of Humira. With current data it is not known if adalimumab treatment influences the risk for developing dysplasia or colon cancer. Slogan The Pulse of the Pharmaceutical Industry.
Humira 40 mg solution for injection in pre-filled syringe
Respiratory tract infections including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral.
Patients treated with Humira usually experienced improvement in haematological signs of chronic inflammation.
Reports of serious allergic reactions including anaphylaxis have been received following Humira administration. Statistically significant increases improvement from Baseline to Week 26 and 52 in Body Mass Index and height velocity were observed for both treatment groups.
Paraesthesias including hypoesthesiamigraine, nerve root compression.