Peanut Allergen Powder
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Peanut Allergen Powder
Peanut allergen powder, sold under the brand name Palforzia, is an oral immunotherapy used for the treatment of children who have confirmed cases of peanut allergy. It is taken by mouth. Peanut allergen powder is a powder that is manufactured from peanuts (''Arachis hypogaea'') and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The accurate dosing of the pharmaceutical product allows use by people with allergies extreme enough to be seriously affected by a few milligrams too much. The most common side effects of peanut allergen powder are abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis. Peanut allergen powder should not be administered to those with uncontrolled asthma. In January 2020, the FDA approved the drug to Aimmune Therapeutics for mit ...
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Oral Administration
Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications. Oral administration can be easier and less painful than other routes of administration, such as Injection (medicine), injection. However, the onset of action is relatively low, and the effectiveness is reduced if it is not absorbed properly in the digestive system, or if it is broken down by digestive enzymes before it can reach the bloodstream. Some medications may cause gastrointestinal side effects, such as nausea or vomiting, when taken orally. Oral administration can also only be applied to conscious patients, and patients able to swallow. Terminology ''Per os'' (; ''P.O.'') is an adverbial phrase meaning literally from Latin "through the mouth" or "by mouth". The expression is used in medicine to describe a treatment that is taken orally (but not ...
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Immunotherapy
Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherapies that reduce or suppress are classified as '' suppression immunotherapies''. Immunotherapy is under preliminary research for its potential to treat various forms of cancer. Cell-based immunotherapies are effective for some cancers. Immune effector cells such as lymphocytes, macrophages, dendritic cells, natural killer cells, and cytotoxic T lymphocytes work together to defend the body against cancer by targeting abnormal antigens expressed on the surface of tumor cells. Vaccine-induced immunity to COVID-19 relies mostly on an immunomodulatory T-cell response. Therapies such as granulocyte colony-stimulating factor (G-CSF), interferons, imiquimod and cellular membrane fractions from bacteria are licensed for medical use. Others in ...
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Peanut Allergy
Peanut allergy is a type of food allergy to peanuts. It is different from tree nut allergy, tree nut allergies, because peanuts are legumes and not true Nut (fruit), nuts. Physical symptoms of allergic reaction can include pruritus, itchiness, hives, angiodema, swelling, eczema, sneezing, asthma attack, abdominal pain, Hypotension, drop in blood pressure, diarrhea, and cardiac arrest. Anaphylaxis may occur. Those with a history of asthma are more likely to be severely affected. It is due to a type I hypersensitivity reaction of the immune system in susceptible individuals. The allergy is recognized "as one of the most severe food allergies due to its prevalence, persistency, and potential severity of allergic reaction". Prevention may be partly achieved through early introduction of peanuts to the diets of pregnant women and babies. It is recommended that babies at high risk be given peanut products in areas where medical care is available as early as 4 months of age. The prin ...
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Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ...
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Peanut
The peanut (''Arachis hypogaea''), also known as the groundnut, goober (US), goober pea, pindar (US) or monkey nut (UK), is a legume crop grown mainly for its edible seeds. It is widely grown in the tropics and subtropics by small and large commercial producers, both as a grain legume and as an oil crop. Atypically among legumes, peanut pods geocarpy, develop underground; this led botanist Carl Linnaeus to name peanuts ''hypogaea'', which means "under the earth". The peanut belongs to the botanical family Fabaceae (or Leguminosae), commonly known as the legume, bean, or pea family. Like most other legumes, peanuts harbor symbiotic nitrogen-fixing bacteria in root nodules, which improve soil fertility, making them valuable in crop rotations. Despite not meeting the Botanical nut, botanical definition of a nut as "a fruit whose ovary (botany), ovary wall becomes hard at maturity," peanuts are usually categorized as nuts for culinary purposes and in common English. Some pe ...
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Hives
Hives, also known as urticaria, is a kind of skin rash with red or flesh-colored, raised, itchy bumps. Hives may burn or sting. The patches of rash may appear on different body parts, with variable duration from minutes to days, and typically do not leave any long-lasting skin change. Fewer than 5% of cases last for more than six weeks (a condition known as chronic urticaria). The condition frequently recurs. Hives frequently occur following an infection or as a result of an allergic reaction such as to medication, insect bites, or food. Psychological stress, cold temperature, or vibration may also be a trigger. In half of cases the cause remains unknown. Risk factors include having conditions such as hay fever or asthma. Diagnosis is typically based on appearance. Patch testing may be useful to determine the allergy. Prevention is by avoiding whatever it is that causes the condition. Treatment is typically with antihistamines, with the second generation antihistamines su ...
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Asthma
Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wheezing, coughing, chest tightness, and shortness of breath. A sudden worsening of asthma symptoms sometimes called an 'asthma attack' or an 'asthma exacerbation' can occur when allergens, pollen, dust, or other particles, are inhaled into the lungs, causing the bronchioles to constrict and produce mucus, which then restricts oxygen flow to the alveoli. These may occur a few times a day or a few times per week. Depending on the person, asthma symptoms may become worse at night or with exercise. Asthma is thought to be caused by a combination of genetic and environmental factors. Environmental factors include exposure to air pollution and allergens. Other potential triggers include medications such as aspirin and beta blockers. Diag ...
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Indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. The opposite of an indication is a contraindication, a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits. In the United States, indications for prescription drugs are approved by the FDA. Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof ...
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Risk Evaluation And Mitigation Strategy
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. The REMS program was formalized in 2007. The FDA determines as part of the drug approval process that a REMS is necessary, and the drug company develops and maintains the individual program. REMS applies only to specific prescription drugs, but can apply to brand-name or generic drugs. REMS for generic drugs may be created in collaboration with the manufacturer of the brand-name drug. The FDA may remove the REMS requirement if it is found to not improve patient safety. The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as isotretinoin, which causes serious birth defects; clozapine, which can cause agranulocytosis; a ...
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Committee For Medicinal Products For Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal product Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...s for human use. See also * Committee for Medicinal Products for Veterinary Use References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ...
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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would ...
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Peanuts
''Peanuts'' (briefly subtitled ''featuring Good ol' Charlie Brown'') is a print syndication, syndicated daily strip, daily and Sunday strip, Sunday American comic strip written and illustrated by Charles M. Schulz. The strip's original run extended from 1950 to 2000, continuing in reruns afterward. ''Peanuts'' is among the most popular and influential in the history of comic strips, with 17,897 strips published in all, making it "arguably the longest story ever told by one human being". At the time of Schulz's death in 2000, ''Peanuts'' ran in over 2,600 newspapers, with a readership of roughly 355 million across 75 countries, and had been translated into 21 languages. It helped to cement the Yonkoma, four-panel gag strip as the standard in the United States, and together with its merchandise earned Schulz more than $1 billion. Following successful TV and theatrical adaptations over the years, a The Peanuts Movie, movie adaptation was released by Blue Sky Studios in 20 ...
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