Humira, which generic name is Adalimumab, is the first recombinant human IgGI monoclonal antibody ( proteins that are made in a research lab, similar to the antibodies that our organic structure produces when are exposed to a disease ) particular for human Tumor Necrosis Factor ( TNF ) . Humira was developed by Abbot Laboratories as a portion of scientific coaction with Cambridge Antibody, and it was approved by the FDA, on December 31, 2002. Humira can be used merely by order of a physician and must be dispensed by a druggist, means that is a prescribed medicine. It has a cost of about 13000 dollars for one twelvemonth for those patients who do non hold any drug coverage. Humira, classified as anti-rheumatic medicine ( DMARD ) , is one of the drug that works barricading the action of TNF, a substance called cytokine, that plays an of import function in presenting messages between the cells, and involved in normal inflammatory and immune system, nowadays at high degree in the synovial fluids in Rheumatoid arthritis and Psoriatic arthritis. This drugs helps to alleviate the hurting in patient with these autoimmune disease, but at the same clip, it decrease the degree of action of the immune system of the organic structure, go forthing the patient at hazard of develop lymphomas, and other infections due to opportunist diseases that had caused the decease of those patient, ground why the FDA is necessitating the maker of TNF blockers to update the Black Box Warning in the prescribing information to alarm about the side consequence of this drugs, doing as cardinal factor to be consider, in the election of this medicine, than the benefit to the patient justified the hazard at which, he or she is traveling to be exposed.
Humira ( Adalimumab ) is a medical specialty called a TNF blocker, that is a type of protein that blocks the action of TNF, involve in our organic structure immune response, and responsible for the redness of the articulations in some patients. Adalimumab, it is a combination of 1330 amino acids and has a molecular weight of 148 kilodaltons. Patient with Rheumatoid Arthritis ( the Body attacks its ain articulations, doing hurting, swelling and loss of map ) and Psoriatic Arthritis ( joint hurting and puffiness and graduated tables in the tegument ) have excessively much of it in their organic structures, ensuing in the onslaught of normal healthy organic structure tissue and doing redness the tissue in castanetss, gristles and articulations. Humira helps to cut down the marks and symptoms of these autoimmune diseases, such as hurting and swollen, may assist forestall farther harm to their castanetss and articulations, and may better their ability to execute day-to-day activities, but besides can take down the ability of the organic structure to contend infections ( PDR, 2007 ) .
Humira is besides used to handle Ankilosing Spondylitis ( redness of the spinal column and sacroiliac articulations, doing hurting and joint harm ) , active Crohn ‘s disease ( redness that affect the GI piece of land, most common the ileum Y and colon, doing hurting, diarrhoea, weight loss and febrility ) and Juvenile Idiopathic Arthritis ( Medline, 2010 ) .
Humira is supplied both in a single-use pen ( Humira pen ) and in single-use, 1 milliliter prefilled glass panpipes as a sterile, solution for hypodermic disposal. Can be given in the venters ( 2 inches off from the navel ) , or in the thighs musculus in the leg. The solution of Humira is crystalline, with a pH of about 5.8, if particulate or colour is noted, the merchandise it should be no used. Each panpipes or write contains 0.8 milliliters equal to 40 milligram adalimumab, which are the recommend dosage for big patient with arthritic arthritis and psoriasis arthritis, given one time a hebdomad, but the dosage can be different for different patient, and besides depend of the medical job why the patient is taking it. The dosage for kids has to be in consideration with the age and weight, and at the same clip it is non recommended for the aged population, a cause the hazard of develops infection due to timeserving diseases ( Mayo clinic, 2010 ) .
Humira has a class B for gestation, there are a few surveies in pregnant adult female taken TNF Inhibitors, and those surveies did non demo an addition of abortions or birth defect, any manner, some surveies from 2009 happen one instance where these medicine might be caused a form of birth defect know as VACTERL ( vertebral, anal, trachea-esophagus, and nephritic birth defect ) . Thus is better used merely if is it clearly needed ( Medline, 2010 ) .
Common side effects of Humira are: concern, high blood pressure, sickness, abdominal hurting, roseola, back hurting, and inflammation, itchiness, contusing as an injection site reaction. The most serious reactions are: serious infections, neurologic events, and malignances. Agreements to a study due for the FDA from December 31, 2002 to July 7, 2009 were 42,852 instance of inauspicious study about Humira, 12,693 were serious, and 1618 succumbed in decease. Reason why the FDA, required the maker of TNF blocker to update the Box Warning, in 2009 ( Durmowicz, MD, 2009 ) .
Boxed Warning: “ Serious infection: increased of serious infections taking to hospitalization and decease, including TB ( TB ) , bacterial sepsis, invasive fungous infections, and infection due to opportunist pathogens ” . “ Malignancy: Lymphoma and other malignance, some fatal, have been reported in kids and striplings patient treated with TNF blockers of which Humira is a member ” ( Durmowicz, MD, 2009 ) .
Warning and safeguard: “ Serious infections, malignances ( lymphomas and leukaemia ) , anaphylaxis, hepatitis B virus, demyelinating disease, cytopenia, histoplasmosis, bosom failure, Lupus syndrome ; and some rare disease, such as Leiomyosarcoma, nephritic carcinoma and hepatic malignances ” ( Durmowicz, MD, 2009 ) .
Humira can non be taken longer with Anakirina or other TNF barricading agent, because the increased of serious infections and is contraindicated. Besides the liver inoculation neither a unrecorded inoculation such infantile paralysis vaccinum, influenza vaccinum should be given at the same time. ( Hazard & A ; Hopfer, 2008 ) .
When I started looking for a instance studied from people who had died from diseases developed a cause of taking Humira, I found 1000 of them, but I merely traveling to advert two to them ;
Case # 1: Jolle Mohr, a 36-year-old adult female who died during a cistron therapy test for Rheumatoid Arthritis, who at the same clip was taking Humira. She died from histoplasmosis, a disease caused by a fungus Histoplasm capsulatum, infection that is documented as a side consequence of Humira. In this instance, the infections spread through her full organic structure, bust uping her variety meats. As we know Humira blocks TNF by stamp downing the immune system, the cistron therapy that her received does the same thing but merely in a mark country, the combination of both left her unfastened to infection, with a truly weak immune system. ( Wired Science 2007 )
Case # 2: “ a 16 twelvemonth old with interstitial pneumonia, fever, productive cough and dyspnoea, died of respiratory failure ; research labs consist with macrophage activation syndrome ; 11 month history of adalimumab usage for Juvenile Idiophatic Arthritis. He besides was treated with antibiotic and cyclosporine “ ( Durmowicz, MD, 2009 ) .