Applies to remdesivir: intravenous powder for solution, intravenous solution. They did not mention the potential for kidney damage or failure linked to infections, including SARS-CoV-2, the infection that causes COVID-19. Clinical studies evaluated its effectiveness, but did not generate conclusive results. Overall, 21% of patients in the 5-day group and 35% in the 10-day group had serious adverse events. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Remdesivir API has six stereocenters and has multiple polymorphic forms.2,3 Using API forms that differ from the API in the FDA-approved drug may affect the compounded drugs quality, including the solubility of the API in the compounded drug. All rights reserved. Gilead Sciences, Inc. (2022). high blood pressure slow heartbeat sinus bradycardia low blood pressure seizures trouble breathing decreased oxygen in the tissues or blood a significant type of allergic reaction called. Remdesivir has potential side-effects on the kidneys, according to data shared by Gilead with the European Medicines Agency, which is assessing its possible toxicity. low albumin, a protein that the liver produces, swelling of the face, throat, tongue, lips, or eyes, pain or discomfort in the right upper stomach area. GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Based on interim results from studying more than 5000 participants, the international study concluded that remdesivir "had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.". By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx. You can report any suspected side effect using the Yellow Card safety scheme. Although not all of these side effects may occur, if they do occur they may need medical attention. Learn more. Covid-19 vaccines have been developed 10 times faster than traditional drugs, but they've passed the phase-3 clinical trials that test whether a potential medicine is both safe and effective in thousands of people. Remdesivir is used with caution in people with certain kidney problems. Can Remdesivir be used to treat COVID-19 (coronavirus)? Remdesivir has the potential to cause kidney issues. Elevated liver enzymes in patients with COVID-19: Look, but not too hard. Copyright 2023 IBM Watson Health. [31] However, the specific way that remdesivir impacts your kidneys is still being studied. Because of this, your care team will monitor you for side effects while youre still on site. other information we have about you. U.S. Food and Drug Administration. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. (2022). Rare side effects of remdesivir include: Hypersensitivity reactions which may include Low blood pressure ( hypotension) High blood pressure ( hypertension) Rapid heart rate (tachycardia) Slow heart rate (bradycardia) Low oxygen in tissues ( hypoxia) Fever Shortness of breath (dyspnea) Wheezing Kokic, G., et al. According to the results of the latest study released by Gilead Sciences, the most common adverse reactions were nausea and acute respiratory failure . Find everything you need to know about remdesivir, including what it is used for, warnings, reviews, side effects, and interactions. vials containing 100 mg powder or 100 mg/20 mL concentrate. Call your doctor for medical advice about side effects. Remdesivir (Veklury) is an antiviral medication that treats several viral infections, including COVID-19. Common side effects of remdesivir include nausea and reactions associated with infusion, such as pain, bleeding, bruising, soreness, and swelling at the injection site. Veklury is an injectable drug and should only be administered in a hospital or in a health care setting capable of providing acute care comparable to inpatient hospital care. These side effects may go away during treatment as your body adjusts to the medicine. Ideally, you should receive it within a week of developing symptoms for it to be most effective. The effects may be increased because of slower removal of the medicine from the body. All rights reserved. Foods that are beneficial for kidney health include dark leafy greens, berries, and apples. Other medications may be effective for treating infections and carry a reduced risk of adverse effects on the kidneys. However, since remdesivir has been approved and recommended for use, weve learned more about its possible risks and side effects. Kidney diseaseUse with caution. Remdesivir doesn't prevent people from being infected by the SARS-CoV-2 virus. That leads us to why it's worth studying remdesivir. The results are consistent with the current WHO guidelines, which recommend remdesivir for patients with severe but non-critical COVID-19 infections. They receive the medication once per day for around 510 days. Stay hydrated throughout the day small but frequent sips of water are often beneficial. Are renal insufficiency and renal failure the same? When you do eat, try to avoid heavy meals. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Following WHO's finding, an article in the British Medical Journal highlighted another antiviral as a cautionary tale: oseltamivir or 'Tamiflu' a drug that aims to block the influenza virus. Background To summarise specific adverse effects of remdesivir, hydroxychloroquine and lopinavir/ritonavir in patients with COVID-19. Number of Patients (Remdesivir) . - Difficulty breathing. [Ref], Very common (10% or more): Increased transaminases, increased ALT, increased AST, Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin, Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests, Frequency not reported: Hyperbilirubinemia, increased direct bilirubin[Ref], Postmarketing reports: Anaphylactic reaction, hypersensitivity[Ref], Uncommon (0.1% to 1%): Injection site erythema, Frequency not reported: Administration site extravasation[Ref], Very common (10% or more): Increased glucose (up to 12%)[Ref], Frequency not reported: Generalized seizure[Ref], Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase, Frequency not reported: Decreased potassium[Ref], Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%), Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury[Ref]. Drug information provided by: IBM Micromedex. The .gov means its official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The authors highlighted the significant association between remdesivir and acute kidney injury and urged the need for more studies into its safety. View remdesivir information, including dose, uses, side-effects, renal impairment, pregnancy, breast feeding, monitoring requirements and important safety information. U.S. Food and Drug Administration (2020, October 22). Indication. Relatively common but manageable side effects are nausea and elevated liver enzymes. Learn more about remdesivir at EverydayHealth.com. A 2020 study of over 1,000 people hospitalized with the disease found that it safely and effectively shortened the time to recovery in adults. It can treat confirmed cases of COVID-19 regardless of whether youre in the hospital. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Acute kidney injury associated with remdesivir: A comprehensive pharmacovigilance analysis of COVID-19 reports in FAERS. Page last reviewed: 18 May 2022 We avoid using tertiary references. Summary on compassionate use for remdesivir Gilead. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. It's also simpler to administer: while remdesivir must be injected, GS-441524 could be ingested in pill form. Medically reviewed by Drugs.com. Your risk for developing kidney problems also depends on your situation. You can learn more about how we ensure our content is accurate and current by reading our. 2004-2023 Healthline Media UK Ltd, Brighton, UK, a Red Ventures Company. All rights reserved. Beneficial with conventional oxygen therapy. - Chills. The results have been contradictory. This may make you feel dizzy, short of breath or very tired. Download and complete the form, then submit it via fax at 1-800-FDA-0178. The effects of remdesivir on vaccinated people and people who have recovered from COVID-19 and the question of how cost-effective remdesivir is remain to be clarified in future studies. Infusion-related reactions have been seen during a remdesivir infusion or around the Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of remdesivir injection in children 28 days of age and older and weighing at least 3 kilograms (kg). If youve left your clinic or hospital and develop serious side effects like these, contact your healthcare provider right away. Keep in mind: The list below isnt an exhaustive list of possible side effects. It's one of many drug candidates that were originally designed in response to the threat from emerging diseases caused by RNA viruses germs like the one behind the 2002 SARS outbreak that have potential to cause global pandemics. Delirium was reported in two patients (Grein et al. vision changes or damage to your retina caused by an anti-malaria medication; heart disease, heart rhythm disorder (such as long QT syndrome ); diabetes; a stomach disorder; an allergy to quinine; liver or kidney disease; psoriasis; alcoholism; porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or A person with reduced kidney function should discuss this with a doctor. Their computer models suggest that remdesivir beats the other drugs because it's the best at binding and destabilizing the RNA polymerase. FDA is concerned that compounders may have difficulty identifying an appropriate solubilizing agent and sourcing one of sufficient quality. 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