Molnupiravir is an experimental medicine being studied for the treatment of mild-to-moderate COVID-19. This drug is still being studied and all of its risks are not yet known.

The US Food and Drug Administration (FDA) has authorized emergency use of molnupiravir for the treatment of mild-to-moderate COVID-19 in people 18 years of age and older:

• have a current diagnosis of mild-to-moderate COVID-19;

• who are at high risk for progression to severe COVID-19, including hospitalization or death; and

• for whom other COVID-19 treatment options are not available or applicable.

Molnupiravir is not authorized for use:

• for initiation of treatment in people needing hospitalization due to COVID-19;

• for prevention before or after exposure of COVID-19; or

• longer than 5 consecutive days.

The US Food and Drug Administration (FDA) has authorized emergency use of molnupiravir for the treatment of mild-to-moderate COVID-19 in people 18 years of age and older.

Take molnupiravir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take molnupiravir (four capsules) every 12 hours for 5 consecutive days.

Take this medicine as soon as possible after diagnosis of COVID-19 and within 5 days of when symptoms first appear.

You may take molnupiravir with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

Being treated with molnupiravir will not make you less contagious to other people. Keep using infection control methods such as self-isolation, social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Molnupiravir is still being studied and all of the risks are not yet known.

Usual Adult Dose for COVID-19:

For investigational use only

800 mg orally every 12 hours for 5 days

Comments:
-The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of the unapproved drug molnupiravir for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, AND who are at high risk for progression to severe COVID-19, including hospitalization or death, AND for whom alternative COVID-19 treatment options authorized by US FDA are not accessible/clinically appropriate; this drug is not approved by the US FDA for this use.
-This drug should be administered as soon as possible after COVID-19 has been diagnosed and within 5 days of symptom onset.
-Safety and efficacy of use beyond 5 days have not been established.
-If hospitalization is required after starting treatment with this drug, the patient may complete the full 5-day treatment course per health care provider's discretion.
-No dose adjustment recommended in elderly patients.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

Use: For the treatment of mild to moderate COVID-19 in patients:
-with positive results of direct SARS-CoV-2 viral testing, and
-who are at high risk for progression to severe COVID-19, including hospitalization or death, and
-for whom alternative COVID-19 treatment options authorized by US FDA are not accessible/clinically appropriate

Tell your doctor if you have any serious or chronic disease.

Molnupiravir may harm an unborn baby if the mother or father is using this medicine:

• If you are a woman, do not use molnupiravir if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 days after your last dose.

• If you are a man, use an effective birth control if your sex partner is pregnant or is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using molnupiravir.

You may need to have a negative pregnancy test before starting this treatment.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of molnupiravir on the baby.

Do not breastfeed while using this medicine, and for at least 4 days after your last dose. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if you are more than 10 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to molnupiravir: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have any new or worsening symptoms.

Common molnupiravir side effects may include:

• diarrhea, nausea; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

You should continue to isolate as directed by your doctor and follow public health practices such as wearing a mask, social distancing, and frequent hand washing.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

The American Society of Health-System Pharmacists, Inc. represents that this information about molnupiravir was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that molnupiravir is not approved for treatment of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, are being investigated for and are currently available under, an FDA emergency use authorization (EUA) for the treatment of COVID-19 in certain adults 18 years of age and older. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information, and specifically disclaims all such warranties. Readers of the information about molnupiravir are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of this information. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information contained in this information is provided for informational purposes only. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. This information about molnupiravir is not to be considered individual patient advice. Because of the changing nature of drug information, you are advised to consult with your physician or pharmacist about specific clinical use of any and all medications.