Wednesday, December 11, 2013

Google Images References: 1 U.S. Food and Drug Administration. FDA approves Benlysta to treat lupus


New therapy, belimumab (Benlysta ) is a specific mclain drug for the treatment mclain of systemic lupus erythematosus. Approved by the FDA (U.S. Food and Drug Administration) in March 2011, this drug had its authorized marketing in Brazil in July of that year 1.2.
This consists of a recently approved for the treatment considerable advancement of the disease since the last drug approved by the FDA for use in patients with lupus were hydroxychloroquine and anti-inflammatory steroids in 1955 1.
The belimumab belongs to the group of medicines called monoclonal antibodies. Its action is based on the autoimmune nature of the disease, it reduces the production of autoantibodies that attack the cells and organs of the affected individual. It is an adult or intravenous drug use which requires about 1 hour to be completely administered 3.
The new pharmacotherapy is indicated as an adjunct in the treatment of patients with SLE who are already in use of standard therapy, such as anti-inflammatory steroids, antimalarials, anti-inflammatory steroids or other immunosuppressive 3. According disclosed by the FDA, the addition of belimumab to the standard treatment regimen decreases the activity of the disease, and potentially further reduce crisis and the doses of anti-inflammatory steroids mclain administered 1.
The cost of the drug is expressive. Each infusion of Benlysta costs U.S. $ 3,800.00 for a patient with 60 kg. Only in the first year of treatment, it is estimated the cost of R $ 57,000.00 for the set of 15 doses, depending mainly on the patient's weight 2.
Google Images References: 1 U.S. Food and Drug Administration. FDA approves Benlysta to treat lupus . [Cited 2013 August 26]. Available in 2 http://www.fda.gov/newsevents/newsroom/pressAnnouncements/ucm246489.htm Brazil approves new biological drug for lupus. Folha de Sao Paulo. [Cited 2013 August 26]. Available in 3 National Health Surveillance Agency. Benlysta . [Cited 2013 August 26]. Available in http://www.anvisa.gov.br/fila_bula/frmVisualizarBula.asp?pNuTransacao=4152582013&pIdAnexo=1625654
About Cemed UFMG Center mclain for the Study of Drug (CEMED), under the Department of Social Pharmacy, Faculty of Pharmacy, UFMG, was created in 1990 with the goal of developing projects for teaching, research and extension related to medication use.
A new drug is always welcome, however, a more rigorous pharmacovigilance in the case of drugs derived from biotechnology and molecular assess mclain adverse effects and establish the cost and benefit in dealing with the high cost of this drug is required.
Dr. Roberto, staff Cemed appreciates your visit to the blog and agree with its placement. After the inclusion of a drug on the market, it is expected that clinical studies continue happening during your marketing. With regard to molecular biotechnology, a recent technique, but should follow in detail the effects of this new technology in patients taking the drug. On the cost / benefit, only the use of the drug and the reporting of clinical results indicate that proportion. To this end, the participation of a multidisciplinary team both in hospitals and in primary care shows it essential. Att, Mariana Colen.
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