Fact Sheet for Patients And Parents/Caregivers

Emergency Use Authorization (EUA) Of Remdesivir For Coronavirus Disease 2019 (COVID-19)

 

You are being given a medicine called remdesivir for the treatment of coronavirus disease 2019 (COVID-19). This Fact Sheet contains information to help you understand the potential risks and potential benefits of taking remdesivir, which you have received or may receive.

 

There is no U.S. Food and Drug Administration (FDA) approved product available to treat COVID-19. Receiving remdesivir may benefit certain people in the hospital with COVID-19. Read this Fact Sheet for information about remdesivir. Talk to your healthcare provider if you have questions. It is your choice to receive remdesivir or stop it at any time.

 

What is COVID-19?

 

COVID-19 is caused by a virus called a coronavirus. This type of coronavirus has not been seen before. This new coronavirus was first found in people in Wuhan, Hubei Province, China in December 2019. Person-to-person spread was reported outside Hubei and in countries outside China, including in the United States. You can get COVID-19 through contact with another person who has the virus.

 

COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your other medical conditions to become worse. Older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for COVID-19.

 

What are the symptoms of COVID-19?

 

The symptoms of COVID- 19 are fever, cough, and shortness of breath, which may appear 2 to14 days after exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to become worse.

 

What is remdesivir?

 

Remdesivir is an investigational antiviral medicine used for the treatment of certain people in the hospital with COVID-19. Remdesivir is investigational because it is still being studied. There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19. Remdesivir was shown in a clinical trial to shorten the time to recovery in some people. There are no medicines approved by the FDA as safe and effective to treat people in the hospital who have COVID -19. Therefore, the FDA has authorized the emergency use of remdesivir for the treatment of COVID-19 under an Emergency Use Authorization (EUA). For more information on EUA, see the "What is an Emergency Use Authorization (EUA)?" section at the end of this Fact Sheet.

 

What should I tell my healthcare provider before I receive remdesivir?

Tell your healthcare provider about all of your medical conditions, including if you:

 

      Have any allergies

 

      Have kidney or liver problems

 

      Are pregnant or plan to become pregnant

 

      Are breastfeeding or plan to breastfeed

 

      Have any serious illnesses

 

      Are taking any medicines (prescription, over-the-counter, vitamins, or herbal products) . Remdesivir may affect the way other medicines work, and other medicines may affect how remdesivir works.

o Especially tell your healthcare provider if you are taking the medicines chloroquine phosphate or hydroxychloroquine sulfate.

 

How will I receive remdesivir?

 

Remdesivir is given to you through a vein (intravenous or IV) one time each day for up to 10 days depending on what your healthcare provider thinks is best for you. Remdesivir may help decrease the amount of the coronavirus in your body. This may help you to get better faster.


 

What are the important possible side effects of remdesivir?

 

Possible side effects of remdesivir are:

 

      Allergic reactions. Remdesivir can cause allergic reactions, including serious reactions, during and after infusion. Tell your healthcare provider or nurse, or get medical help right away if you get any of the following signs and symptoms of allergic reactions: low blood pressure, changes in your heartbeat, shortness of breath, wheezing, swelling of your lips, face, or throat, rash, nausea, vomiting, sweating, or shivering.

 

      Increases in levels of liver enzymes. Increases in levels of liver enzymes have been seen in people who have received remdesivir, which may be a sign of inflammation or damage to cells in the liver. Your healthcare provider will do blood tests to check your liver before you receive remdesivir and daily while receiving remdesivir.

 

These are not all the possible side effects of remdesivir. Remdesivir is still being studied so it is possible that all of the risks are not known at this time.

 

Not a lot of people have taken remdesivir. Serious and unexpected side effects may happen. The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site.

 

What other treatment choices are there?

 

Like remdesivir, FDA may allow for the emergency use of other medicines to treat people in the hospital with COVID-19. Go to www.cdc.gov/COVID19 for information on the emergency use of other medicines that are not approved by FDA to treat people in the hospital with COVID-19. Your healthcare provider may talk with you about clinical trials you may be eligible for.

 

It is your choice to be treated or not to be treated with remdesivir. Should you decide not to receive it or stop it at any time, it will not change your standard medical care.

 

What if I am pregnant or breastfeeding?

 

There is limited experience giving remdesivir to pregnant women or breastfeeding mothers. For a mother and unborn baby, the benefit of receiving remdesivir may be greater than the risk from the treatment. If you are pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

 

How do I report side effects with remdesivir?

 

Tell your healthcare provider right away if you have any side effect that bothers you or does not go away.

 

Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.

 

How can I learn more?

 

      Ask your healthcare provider.

 

      Visit http://www.cdc.gov/COVID19

 

      Contact your local or state public health department.

 

What is an Emergency Use Authorization (EUA)?

 

The United States FDA has made remdesivir available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

 

Remdesivir has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID -19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.


 

The EUA for remdesivir is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

 

ⓒ 2020 Gilead Sciences, Inc. All rights reserved.

 

Revised: 06/2020

 

Reference

 

US Food and Drug Administration. Fact sheet for health care providers Emergency Use Authorization (EUA) of remdesivir (GS-5734™). https://www.fda.gov/media/137566/download. Accessed May 1, 2020.