Humira, which generic name is Adalimumab, is the first recombinant human IgGI monoclonal antibody (proteins that are made in a laboratory, similar to the antibodies that our body produces when are exposed to a disease) specific for human Tumor Necrosis Factor (TNF). Humira was developed by Abbot Laboratories as a part of scientific collaboration with Cambridge Antibody, and it was approved by the FDA, on December 31, 2002. Humira can be used only by order of a physician and must be dispensed by a pharmacist, means that is a prescribed medication. It has a cost of approximately 13000 dollars for one year for those patients who do not have any drug coverage. Humira, classified as anti-rheumatic medication (DMARD), is one of the drug that works blocking the action of TNF, a substance called cytokine, that plays an important role in delivering messages between the cells, and involved in normal inflammatory and immune system, present at high level in the synovial fluids in Rheumatoid arthritis and Psoriatic arthritis. This drugs helps to relieve the pain in patient with these autoimmune disease, but at the same time, it decrease the level of action of the immune system of the body, leaving the patient at risk of develop lymphomas, and other infections due to opportunist diseases that had caused the death of those patient, reason why the FDA is requiring the manufacturer of TNF blockers to update the Black Box Warning in the prescribing information to alert about the side effect of this drugs, making as fundamental factor to be consider, in the election of this medication, than the benefit to the patient justified the risk at which, he or she is going to be exposed.
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Humira (Adalimumab) is a medicine called a TNF blocker, that is a type of protein that blocks the action of TNF, involve in our body immune response, and responsible for the inflammation of the joints 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 own joints, causing pain, swelling and loss of function) and Psoriatic Arthritis ( joint pain and swelling and scales in the skin) have too much of it in their bodies, resulting in the attack of normal healthy body tissue and causing inflammation the tissue in bones, cartilages and joints. Humira helps to reduce the signs and symptoms of these autoimmune diseases, such as pain and swollen, may help prevent further damage to their bones and joints, and may improve their ability to perform daily activities, but also can lower the ability of the body to fight infections (PDR, 2007).
Humira is also used to treat Ankilosing Spondylitis( inflammation of the spine and sacroiliac joints, causing pain and joint damage ), active Crohn's disease( inflammation that affect the GI tract, most common the ileum y and colon, causing pain, diarrhea, weight loss and fever) and Juvenile Idiopathic Arthritis ( Medline, 2010).
Humira is supplied both in a single-use pen (Humira pen) and in single-use, 1 ml prefilled glass syringes as a sterile, solution for subcutaneous administration. Can be given in the abdomen (2 inches away from the umbilicus), or in the thighs muscle in the leg. The solution of Humira is transparent, with a pH of about 5.8, if particulate or coloration is noted, the product it should be no used. Each syringes or pen contains 0.8 ml equal to 40 mg adalimumab, which are the recommend dose for adult patient with rheumatoid arthritis and psoriasis arthritis, given once a week, but the dose can be different for different patient, and also depend of the medical problem why the patient is taking it. The dose for children has to be in consideration with the age and weight, and at the same time it is not recommended for the elderly population, a cause the risk of develops infection due to opportunistic diseases (Mayo clinic, 2010).
Humira has a category B for pregnancy, there are a few studies in pregnant woman taken TNF Inhibitors, and those studies did not show an increase of miscarriages or birth defect, any way, some studies from 2009 find one case where these medication might be caused a pattern of birth defect know as VACTERL (vertebral, anal, trachea-esophagus, and renal birth defect). Thus is better used only if is it clearly needed (Medline, 2010).
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Common side effects of Humira are: headache, hypertension, nausea, abdominal pain, rash, back pain, and redness, itching, bruising as an injection site reaction. The most serious reactions are: serious infections, neurologic events, and malignancies. Accords to a report due for the FDA from December 31, 2002 to July 7, 2009 were 42,852 case of adverse report about Humira, 12,693 were serious, and 1618 succumbed in death. Reason why the FDA, required the manufacturer of TNF blocker to update the Box Warning, in 2009 (Durmowicz, MD, 2009 ).
Boxed Warning: "Serious infection: increased of serious infections leading to hospitalization and death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and infection due to opportunist pathogens". "Malignancy: Lymphoma and other malignancy, some fatal, have been reported in children and adolescents patient treated with TNF blockers of which Humira is a member" (Durmowicz, MD, 2009).
Warning and precaution: " Serious infections, malignancies( lymphomas and leukemia), anaphylaxis, hepatitis B virus, demyelinating disease, cytopenia, histoplasmosis, heart failure, Lupus syndrome; and some rare disease, such as Leiomyosarcoma, renal carcinoma and hepatic malignancies" (Durmowicz, MD, 2009).
Humira cannot be taken longer with Anakirina or other TNF blocking agent, because the increased of serious infections and is contraindicated. Also the liver vaccination neither a live vaccination such polio vaccine, influenza vaccine should be given concurrently. (Hazard & Hopfer, 2008).
When I started looking for a case studied from people who had died from diseases developed a cause of taking Humira, I found thousand of them, but I only going to mention two to them;
Case #1: Jolle Mohr, a 36-year-old woman who died during a gene therapy trial for Rheumatoid Arthritis, who at the same time was taking Humira. She died from histoplasmosis, a disease caused by a fungus Histoplasm capsulatum, infection that is documented as a side effect of Humira. In this case, the infections spread through her entire body, wrecking her organs. As we know Humira blocks TNF by suppressing the immune system, the gene therapy that her received does the same thing but only in a target area, the combination of both left her open to infection, with a really weak immune system. (Wired Science 2007)
Case #2: "a 16 year old with interstitial pneumonia, pyrexia, productive cough and dyspnea, died of respiratory failure; laboratories consist with macrophage activation syndrome; 11 month history of adalimumab use for Juvenile Idiophatic Arthritis. He also was treated with antibiotic and cyclosporine "(Durmowicz, MD, 2009).