COVID-19 Oral Treatments - Information for Providers
Treatment for COVID-19 is recommended for some people who have tested positive for COVID-19. For patients who are at high risk of severe COVID-19 disease, there are currently two available oral treatments:
These treatments are authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) while clinical studies continue to look at their usefulness and safety.
Treatments must be given within 5 days of developing symptoms.
Frequently Asked Questions
Please read the Frequently Asked Questions (FAQ) so you can help protect yourself, your family, your friends, and your community.
What outpatient options are currently available for COVID-19 treatment?
Are the COVID oral treatments FDA approved?
- No, these medications have been granted an emergency use authorization (EUA).
- This is the Food and Drug Administration (FDA) authorization of an unapproved product or unapproved uses of an approved product for emergency use.
- EUA is NOT the same as FDA approval.
- EUA medications are considered investigational.
What should individuals of childbearing potential know about oral treatments?
There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Benefit of Paxlovid may outweigh risk. The Society of Maternal Fetal Medicine has issued a statement supporting the use of Paxlovid in pregnant patients who meet the clinical qualifications. Talk to your health care provider regarding the risks and benefits of this medication if you are pregnant.
Tell your healthcare provider if you are taking combined hormonal contraceptive. Paxlovid may affect how your birth control pills work. It is recommended that you use effective barrier contraception or do not have sexual activity while taking Paxlovid and for four days following treatment.
For individuals who are able to become pregnant:
- You should use a reliable method of birth control (contraception) consistently and correctly during treatment with molnupiravir and for 4 days after the last dose of molnupiravir. Talk to your healthcare provider about reliable birth control methods.
- Before starting treatment with molnupiravir your healthcare provider may do a pregnancy test to see if you are pregnant before starting treatment with molnupiravir.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with molnupiravir.
For individuals who are sexually active with partners who are able to become pregnant:
- It is not known if molnupiravir can affect sperm. While the risk is regarded as low, animal studies to fully assess the potential for molnupiravir to affect the babies of males treated with molnupiravir have not been completed. The risk to sperm beyond 3 months is not known. Studies to understand the risk to sperm beyond 3 months are ongoing.
- A reliable method of birth control (contraception) should be used consistently and correctly during treatment with molnupiravir and for at least 3 months after the last dose.
- Talk to your healthcare provider about reliable birth control methods. Talk to your healthcare provider if you have questions or concerns about how molnupiravir may affect sperm.
Are oral treatments effective against current variants?
Is there a cost for this treatment?
- There may be some costs associated with the treatment. Patients should talk to their provider regarding the cost of treatment and available coverage options.
Are there tools to guide COVID-19 treatment selection?
Questions about Prescribing Oral Treatments
What Information must I provide to my patients regarding these products?
Providers should review the FDA fact sheets for providers and carefully review required consultation, contraindications, and potential drug interactions prior to prescribing either of the new oral therapeutics. Providers should be aware that the pharmacy may not have access to medication lists for patients. Prescribers are responsible for assessing any potential drug interactions prior to prescribing an oral therapeutic.
Paxlovid Factsheet for Healthcare Providers
Molnupiravir Factsheet for Healthcare Providers
In addition, prescribing health care providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving molnupiravir or paxlovid and must document that the patient/caregiver has been given an electronic or hardcopy of the “Fact Sheet for Patients and Caregivers”
Paxlovid Factsheet for Patients, Parents, and Caregivers
Molnupiravir Factsheet for Patients, Parents, and Caregivers
Weekly HHS Office Hours
New information regarding these treatments, administration and their distribution is provided weekly by the federal government. If you are interested in joining, please email COVID19Therapeutics@hhs.gov to request Zoom links.