Pharmacology Tezspire Essay
The pursuit and implementation of evidence-based approaches to sickness prevention and treatment significantly impact people’s health worldwide. The US Food and Drug Administration (FDA) and other regulatory bodies worldwide have made significant contributions to the pursuit of this goal (Fleming et al., 2017). It is the responsibility of the FDA to guarantee the efficacy, safety, and security of human and veterinary medications, medical devices, biologics, and the nation’s food supply, radiation-emitting goods, and cosmetics to protect public health. The FDA is in charge of approving safe pharmaceuticals to treat human illnesses every year. Tezspire is a medication that was approved by the Food last year. Tezspire is discussed in terms of pharmacodynamics and pharmacokinetics, diseases for which the drug is used, differences between the agent and currently available therapies, potential effects associated with the agent, any necessary monitoring parameters, and whether I would personally prescribe the agent or stick with currently available alternatives.
Description of Tezspire
Tezpsire is also known as Tezepelumab. The FDA approved the drug on 17th December 2021 (Stewart, 2021). The drug is used to treat severe asthma and can be used alone or with other medications. Tezspire belongs to a class of medication known as monoclonal antibodies anti-asthmatics. The drug’s safety is not known for children of 12 years and below. Adults and children aged 12 and up with severe asthma should use the medicine as an add-on maintenance treatment. The recommended dosage of the drug is 210 mg, administered subcutaneously after every four weeks (Cunha, 2022). Missed doses should be administered as soon as possible and continued dosing on the usual administration day.
Pharmacodynamics of Tezspire
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Tezspire is a human monoclonal antibody that inhibits thymic stromal lymphopoietic cell proliferation. Tezspire improves the disease markers in asthmatic patients, including airway submucosal eosinophils and blood and IgE, FeNO, IL-5, and IL-13 levels (Ly et al., 2021).
Pharmacokinetics of Tezspire
The medication is injected subcutaneously and reaches maximal concentration in 3-10 days, with a 77 percent absolute bioavailability regardless of the injection site. Following a single subcutaneous injection, the medication exhibits dose-proportional pharmacokinetics over a range of 2.1-420 mg (Drugbank, 2021). Tezspire exhibits steady-state kinetics after 12 weeks with a 1.86 fold Ctrough accumulation ratio using a four-week dosage schedule (Drugbank, 2021). The pharmacokinetics of tezspire are not predicted to vary significantly in patients with renal or hepatic impairment. The medication does not affect protein binding. Proteolytic enzymes throughout the body destroy the medicine because it is a monoclonal antibody. The medication is removed by catabolism at the therapeutic dose, and there is no indication of targeted mediated clearance.
Overview for Disease for Which the Drug Is Used
Asthma is a chronic obstructive pulmonary disease (COPD) marked by reducing airflow, ongoing inflammation, and airway remodeling. The medication is used to treat severe asthma. T2, which includes eosinophilic and allergic manifestations, and T2 –low, which includes paucinogranuocytic and neutrophilic manifestations, are the two forms of the disease. Different routes cause different forms of asthma. Severe asthma affects about ten percent of asthma patients (Drugbank, 2021). Severe asthma may remain uncontrolled despite inhaled asthma controllers and currently available biologic treatments and oral corticosteroids. As a result of the complexity of severe asthma, many patients have unclear, or many causes of inflammation and may not be eligible for or respond effectively to current biologic medication.
The Difference Between Tezspire and Currently Available Therapies
Tezspire is a new potent asthma medicine developed by Amgen and AstraZeneca that has a novel method of action. Adults and children aged 12 and up who have severe asthma should use the medicine as an add-on maintenance treatment. Unlike other asthma drugs, the substance is not intended to treat acute bronchospasm or status asthmatics. The medicine can potentially transform the treatment of severe asthma that has failed to react to the current pharmacologic medications of inhaled therapies, oral corticosteroids, and biologics (Park, 2022). The medicine functions differently than any other anti-asthmatic medication now available. The medicine is efficacious without being linked to the eosinophilic illness profile, and it is appropriate for a wide range of patients. The medicine is the only biologic for severe asthma without a phenotypic or biomarker restriction on its authorized label. Oral corticosteroids are a cheap and widely available medication for severe asthma, but they have a lot of severe side effects; the drug is considerably safer for people with severe asthma.
Potential Risks Associated with the Agent
Tezspire is associated with potential side effects which entail. Individuals may present with difficulty breathing at the initial phases of drug administration. The difficulty in breathing can be severe and need urgent attention following the drug administration (Stewart, 2022). Secondly, severe dizziness, which occurs, can occur hours to days following the administration of the drug. Individuals should seek medical attention immediately following the feeling of dizziness. Thirdly, rash at the injection site and other body parts as potential side effects of the drug. The rash may be due to an allergy to the tezspire. Moreover, swelling of the face, lips, tongue, or throat. The swelling episode is rare, and it can subside on its own.
The drug’s most common side effects entail sore throat, also known as pharyngitis. The sore throat occurs days after the administration of the drug. Individuals should use antihistamine and lozenges to soothe the throat. Secondly, joint pain is common among the patients using the drug. Joint pain can develop days to weeks after the drug administration (Stewart, 2022). Individuals should use pain medications such as NSAIDs to relieve joint pain.
Furthermore, back pain occurs following the administration of the drug. Back pain occurs following the drug metabolism process in the body. The back pain can be relieved by using pain medications following the administration of tezspire.
The parameters to be monitored following administration of the drug entail monitoring the patient’s breathing rate as frequently as possible. The drug has the potential to cause disturbances in the breathing rate. Secondly, monitor for changes in the skin. The drug has potential effects on the skin, which should be monitored.
Whether I Would Personally Prescribe the Agent
The FDA has approved the drug as safe for treating severe asthma. Following the efficacy and safety of the drug, I would personally prescribe the medication to patients presenting with severe asthma. The drug has minimal side effects compared to the currently available medication in the market to treat asthma. In addition, the drug provides relief to patients with asthma and is only administered once after four weeks. The drug is also associated with asthma exacerbations requiring an emergency room visit or hospitalization. Following the reduced exacerbations, the drug is more effective in managing asthma patients. I will use the drug in combination with other approved medications for asthma.
Tezspire is a new medication that has been approved for the management of severe asthma. The drug is approved for adults patients and children above 12 years. Tezspire can provide adequate therapeutic relief to patients with severe asthma following effective use. Compared to the available asthma medications in the market, the drug has minimal side effects, proving safe for use. More research should be done on the medications to gather more information about them, which is currently unavailable.
Cunha, J. P. (2022, January 5). Tezspire. RxList; RxList. https://www.rxlist.com/tezspire-drug.htm#description
Drugbank. (2021, December 28). Tezepelumab. Go.drugbank.com. https://go.drugbank.com/drugs/DB15090
Fleming, T. R., Demets, D. L., & McShane, L. M. (2017). Discussion: The role, position, and function of the FDA—The past, present, and future. Biostatistics (Oxford, England), 18(3), 417–421. https://doi.org/10.1093/biostatistics/kxx023
Gubar, M. (2021, December 19). Tezspire: Effective Treatment for Severe Uncontrolled Asthma. BioPharma Media. https://biopharma.media/tezepelumab-effective-treatment-for-severe-uncontrolled-asthma-1520/
Ly, N., Zheng, Y., Griffiths, J. M., van der Merwe, R., Agoram, B., Parnes, J. R., & Roskos, L. (2021). Pharmacokinetic and Pharmacodynamic Modeling of Tezepelumab to Guide Phase 3 Dose Selection for Patients With Severe Asthma. Journal of Clinical Pharmacology, 61(7), 901–912. https://doi.org/10.1002/jcph.1803
Park, B. (2022, January 13). Tezspire Now Available for Treatment of Severe Asthma. MPR. https://www.empr.com/home/news/tezspire-now-available-for-treatment-of-severe-asthma/
Stewart, J. (2021, December 20). Tezspire (tezepelumab-ekko) FDA Approval History. Drugs.com. https://www.drugs.com/history/tezspire.html
Stewart, J. (2022, January 24). Tezspire: Uses, Dosage, Side Effects & Warnings. Drugs.com. https://www.drugs.com/tezspire.html
Choose a drug that has been approved by the FDA within the past year.
Write a 1,000-1,250 word paper in which you:
Describe the drug approved by the FDA. Include the pharmacodynamics and pharmacokinetic properties of the chosen drug.
Provide an overview of the disease state for which the drug is used.
Describe what is different about this agent compared to currently available therapies.
Discuss the potential risks associated with this agent and any monitoring parameters that are necessary.
Decide whether you would personally prescribe this agent or stick with currently available alternatives.
You are required to cite 5-10 sources to complete this assignment. Sources must be published within the last 5 years and appropriate for the assignment criteria and nursing content.
Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center.
This assignment uses a rubric. Review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.