{"id":48972,"date":"2022-02-14T15:15:58","date_gmt":"2022-02-14T20:15:58","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=48972"},"modified":"2022-04-06T10:23:37","modified_gmt":"2022-04-06T14:23:37","slug":"evusheld-covid-prevention","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/evusheld-covid-prevention\/","title":{"rendered":"Everything you need to know about Evusheld"},"content":{"rendered":"<p><i><span style=\"font-weight: 400;\">CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news and information changes. For the latest on the COVID-19 pandemic, please visit the<\/span><\/i> <a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/index.html\" target=\"_blank\" rel=\"noopener\"><i><span style=\"font-weight: 400;\">Centers for Disease Control and Prevention<\/span><\/i><\/a><i><span style=\"font-weight: 400;\">.<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">Evusheld, a COVID-19 prevention medication manufactured by AstraZeneca, received emergency use authorization (EUA) from the <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">U.S. Food and Drug Administration<\/span><\/a><span style=\"font-weight: 400;\"> (FDA) on Dec. 8, 2021. It is not intended to replace a <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/compare-covid-vaccines\/\"><span style=\"font-weight: 400;\">COVID-19 vaccine series<\/span><\/a><span style=\"font-weight: 400;\"> for anyone who is eligible. It is a protective option for those who cannot receive the COVID vaccine or who may not mount an adequate immune response to the vaccine\u2014specifically those with a history of severe adverse reactions or allergic reaction to vaccines or those who are immunocompromised due to medication or a medical condition.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">What is Evusheld?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Evusheld is a combination of two human monoclonal antibodies (tixagevimab and cilgavimab) that are co-packaged and administered together. It\u2019s the first monoclonal antibody therapy intended to work as a pre-exposure prophylaxis for people who are not yet infected with COVID-19. \u201cThe previous monoclonal antibodies, (bamlanivimab and etesevimab, <\/span><a href=\"https:\/\/www.fda.gov\/media\/145611\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">REGEN-COV<\/span><\/a><span style=\"font-weight: 400;\"> [casirivimab and imdevimab], and <\/span><a href=\"https:\/\/www.fda.gov\/media\/149534\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">sotrovimab<\/span><\/a><span style=\"font-weight: 400;\">), were authorized for \u2026 treatment of COVID-19,\u201d says <\/span><a href=\"https:\/\/www.telemed2u.com\/meet-our-team\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Javeed Siddiqui,<\/span><\/a><span style=\"font-weight: 400;\"> MD, MPH, the co-founder and chief medical officer at TeleMed2U in California. Bamlanivimab\u00a0 and etesvimab, and REGEN-COV, also held EUAs for post-exposure prophylaxis.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/media\/154703\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Monoclonal antibodies<\/span><\/a><span style=\"font-weight: 400;\"> (mAbs) are laboratory-produced molecules that restore, improve, or replicate the immune system\u2019s defenses against pathogens.<\/span> <span style=\"font-weight: 400;\">Evusheld works by targeting the <\/span><a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2788354\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">surface spike protein of the SARS-CoV-2 virus<\/span><\/a><span style=\"font-weight: 400;\">, thereby preventing it from interacting with the human ACE2 receptor, which is required for virus attachment and incorporation into human cells.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">So far, the combination monoclonal preventive treatment appears to be effective against all known variants of the novel coronavirus\u2014including Delta and Omicron variants, although the <\/span><a href=\"https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2788354\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">neutralizing activity is decreased against Omicron<\/span><\/a><span style=\"font-weight: 400;\">. \u201cAfter receiving Evusheld, if you do test positive for COVID, the prevailing thought is that your immune system is primed and much more prepared to fight a COVID-19 infection,\u201d says <\/span><a href=\"http:\/\/www.dr911md.com\/bio.php\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Robert Glatter, MD<\/span><\/a><span style=\"font-weight: 400;\">, an emergency medicine physician at <\/span><a href=\"https:\/\/lenoxhill.northwell.edu\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Lenox Hill Hospital<\/span><\/a><span style=\"font-weight: 400;\"> in New York. \u201cIf you do get infected, you will likely have a mild infection or may even be asymptomatic.\u201d\u00a0<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/drug-classes\/monoclonal-antibodies\"><b>What are monoclonal antibodies?<\/b><\/a><\/p>\n<h3><span style=\"font-weight: 400;\">Dosage<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">The recommended dosage of Evusheld is 150 mg of tixagevimab and 150 mg of cilgavimab. \u201cEach antibody should be administered as intramuscular injections at separate sites on the body,\u201d says Dr. Siddiqui. The gluteal muscles are the preferred sites of injection, and patients should be monitored for a minimum of one hour after the pair of shots are given. Evusheld can be administered to the same patient once every six months.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Evusheld is authorized for use in adults and adolescents over 12 years of age who weigh a minimum of 88 pounds. It is meant to be administered before exposure to or infection with COVID-19 and can be given in an outpatient setting. \u201cThe antibodies should not be used for treatment or post-exposure prophylaxis of COVID-19, or within two weeks after administration of a COVID-19 vaccine,\u201d Dr. Siddiqui says. However, an antibody test is not required before receiving Evusheld.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Side effects<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">In <\/span><a href=\"https:\/\/www.fda.gov\/media\/154701\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">clinical trials<\/span><\/a><span style=\"font-weight: 400;\"> of tixagevimab and of cilgavimab<\/span><span style=\"font-weight: 400;\">, <\/span><span style=\"font-weight: 400;\">35% of those who received the drug experienced mild to moderate adverse reactions, similar to the amount of those in the placebo group. The most common side-effects reported were:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Headache<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fatigue<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cough<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Overall, in the clinical trials, the medication was tolerated well. The following serious adverse effects were rare, affecting only 0.6% of those who received the drug:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">C<\/span><span style=\"font-weight: 400;\">oronary artery disease or myocardial ischemia<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Myocardial infarctions<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Cardiac failure<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Arrhythmia<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Other (cardiomegaly, cardiomyopathy, and cardio-respiratory arrest)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">It\u2019s important to note that all of the participants who experienced a cardiac event had cardiac risk factors or a history of cardiac disease at baseline. Because the medication is so new, it is not known at this time whether side effects can be minimized.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the trial, people who received Evusheld had a 77% reduction in risk of contracting COVID-19 compared with those who received a placebo. \u201cWhile Evusheld does not completely remove the risk of contracting COVID-19,\u201d Dr. Glatter says, \u201cit helps to blunt the potentially serious clinical course that could result in persons who are immunocompromised.\u201d That means it decreases the risk of developing severe COVID-19.<\/span><\/p>\n<h3><span style=\"font-weight: 400;\">Contraindications and restrictions<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">Evusheld is not authorized for use in pediatric patients under the age of 12 or those who weigh less than 40 kilograms (88 pounds). In clinical trials, there was no increase in adverse events among those over 65 years old or over 75 years old, so no limitations have been placed on older patients.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To date, there is no data on the safety of Evusheld in those who are pregnant or breastfeeding. At present, the FDA recommends that the medication only be used when the benefits outweigh the risk to the mother and the fetus.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Evusheld is approved for use in patients with mild to moderate renal impairment. Currently, no contraindications have been identified for patients with severe renal impairment or for patients on dialysis. There are no specific recommendations for those with hepatic impairment at this time.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">When will it be available?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Although Evusheld is available now, many large health systems in the U.S. have limited supplies. In December 2021, the U.S. government purchased 700,000 doses of Evusheld.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On Jan. 12, 2022, <\/span><a href=\"https:\/\/www.reuters.com\/world\/us\/astrazeneca-says-us-buy-additional-500000-evusheld-doses-2022-01-12\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">AstraZeneca<\/span><\/a><span style=\"font-weight: 400;\"> announced that the U.S. government agreed to purchase 500,000 additional doses of Evusheld, for a total of 1.2 million.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Healthcare providers are reaching out to immunocompromised patients who are eligible to receive the injections, working to get the COVID-19 prevention to the people who need it most and to distribute the limited doses in the most equitable way possible. \u201cSome institutions have implemented a lottery that prioritizes the most immunocompromised patients to help make distribution fair,\u201d Dr. Glatter says. In instances of limited availability, priority should be given to those who are at highest risk of severe SARS-CoV-2.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Where to buy Evusheld<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Allocation is handled primarily through the local health department. \u201cCurrently, there is limited information on availability and access to Evusheld will be varied,\u201d says Dr. Siddiqui.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Those who receive Evusheld must receive one hour of post-administration observation. \u201cTherefore, clinics, hospitals and out-patient infusion centers are most likely best equipped to offer this medication,\u201d Dr. Sidiqqui explains.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How much does Evusheld cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Because the federal government has purchased a supply of monoclonal antibody doses, there is typically no cost to the patient for the injection itself, <\/span><a href=\"https:\/\/www.phe.gov\/emergency\/events\/COVID19\/therapeutics\/Pages\/mAb-cost-and-coverage-faqs.aspx\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">according to the U.S. Department of Health and Human Services<\/span><\/a><span style=\"font-weight: 400;\">. However, patients may be charged an administration fee by their providers. When in doubt, check with your insurance company first.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Currently, Medicare is covering the costs of injection and administration. Patients without insurance should also ask their treatment facility if they will be responsible for any costs.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Other COVID treatment updates<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Evusheld is not a treatment and therefore will not be used in patients who are currently infected with coronavirus. The following COVID-19 therapeutics are available for nonhospitalized patients with mild to moderate cases of COVID-19 who are at high risk of serious disease progression, according to a statement updated by the <\/span><a href=\"https:\/\/www.covid19treatmentguidelines.nih.gov\/therapies\/statement-on-therapies-for-high-risk-nonhospitalized-patients\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">National Institute of Health\u2019s COVID-19 Treatment Guidelines Panel<\/span><\/a><span style=\"font-weight: 400;\"> on January 19, 2022. They are ranked in order of recommendation, with Pavloxid being the favored treatment. <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/news\/molnupiravir-covid-pill\/\"><span style=\"font-weight: 400;\">Molnupiravir<\/span><\/a><span style=\"font-weight: 400;\"> should be the last treatment considered because in trials of the drug, it only reduced the risk of hospitalization or death by 30%, compared to 88% with Pavloxid,\u00a0 87% with Remdesivir, and 70%-85% with Sotrovimab.<\/span><\/p>\n<ol>\n<li><b>Paxlovid (ritonavir-boosted nirmatrelvir):<\/b><span style=\"font-weight: 400;\"> Dosage is 300 mg of nirmatrelvir and 100mg of ritonavir,\u00a0 taken orally twice daily for five days as soon as possible within five days of symptom onset. Because Pavloxid has significant drug interactions, providers must review their patients\u2019 medications before prescribing the treatment and may need to utilize alternatives if severe interactions exist.\u00a0<\/span><\/li>\n<li><a href=\"https:\/\/www.singlecare.com\/prescription\/sotrovimab\"><b>Sotrovimab<\/b><\/a><b>:<\/b><span style=\"font-weight: 400;\"> Dosage is a 500 mg intravenous antibody infusion administered as soon as possible up to 10 days after symptom onset. Patients must be monitored for an hour after receiving the infusion in case of severe allergic reaction. Unlike Evusheld, which is a preventive therapy, sotrovimab is a monoclonal antibody treatment for mild to moderate COVID-19 in those patients at risk for progressing to severe disease.<\/span><\/li>\n<li><b>REGEN-COV:<\/b><span style=\"font-weight: 400;\"> Like sotrovimab, REGEN-COV is a monoclonal antibody treatment for COVID-19 whereas Evusheld is a preventive therapy. Dosage is 600 mg of casirivimab and 600 mg of imdevimab administered via IV or subcutaneous injection. On Jan. 24, 2022, the <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-limits-use-certain-monoclonal-antibodies-treat-covid-19-due-omicron\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA amended REGEN-COV&#8217;s EUA<\/span><\/a><span style=\"font-weight: 400;\"> to restrict its use in regions of the United States where exposure is likely due to a variant not susceptible to this treatment, such as the Omicron variant. Given the predominance of the Omicron variant across the U.S., REGEN-COV is not currently authorized for use.\u00a0<\/span><\/li>\n<li><a href=\"https:\/\/www.singlecare.com\/prescription\/remdesivir\"><b>Remdesivir<\/b><\/a><b>: <\/b><span style=\"font-weight: 400;\">\u00a0Dosage is intravenous infusion for three consecutive days (200 mg on day 1 followed by 100 mg on days 2 and 3) administered in a setting such as a medical center as soon as possible up to seven days of symptom onset. Patients must be monitored for an hour after receiving the infusion in case of severe allergic reaction.<\/span><\/li>\n<li><b>Molnupiravir: <\/b><span style=\"font-weight: 400;\">Dosage is 800 mg taken orally twice a day for five days as soon as possible within five days of symptom onset. The drug is not recommended in pregnant individuals.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Eligible patients can receive the antiviral treatments Pavloxid, sotrovimab, remdesivir, and molnupiravir free of charge from the federal government.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On Feb. 11, 2022, the <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-treatment-covid-19-retains\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA issued an EUA<\/span><\/a><span style=\"font-weight: 400;\"> for yet another monoclonal antibody for treatment of mild to moderate COVID-19, which retains activity against the Omicron variant, known as <\/span><a href=\"https:\/\/www.fda.gov\/media\/156153\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">bebtelovimab.<\/span><\/a><span style=\"font-weight: 400;\"> The dose is a single 175 mg injection, which can be administered in those at high risk of progressing to severe disease within seven days of symptom onset.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news and information changes. For the latest on the COVID-19 pandemic, please visit the Centers for Disease Control and Prevention. Evusheld, a COVID-19 prevention medication manufactured by AstraZeneca, received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on Dec. 8, 2021. [&hellip;]<\/p>\n","protected":false},"author":94,"featured_media":50651,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[14636,4141],"coauthors":[20608],"class_list":["post-48972","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-coronavirus","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Evusheld for COVID-19 prevention: Dose, side effects, cost<\/title>\n<meta name=\"description\" content=\"Evusheld is the first authorized monoclonal antibody therapy for COVID-19 prevention. 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