Molnupiravir

IMPORTANT WARNING:

Molnupiravir is currently being studied for the treatment of coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus.

Only limited clinical trial information is available at this time to support the use of molnupiravir for the treatment of COVID-19. More information is needed to know how well molnupiravir will work for the treatment of COVID-19 and the possible adverse events from it.

Molnupiravir has not undergone the standard review to be approved by the FDA for use. However, the FDA has approved an Emergency Use Authorization (EUA) to allow certain adults to receive molnupiravir for treatment of COVID-19.

WHY is this medicine prescribed?

Molnupiravir is used to treat coronavirus disease 2019 (COVID-19 infection) caused by the SARS-CoV-2 virus in adults who have mild to moderate symptoms and are at risk of severe disease that could result in hospitalization or death when other treatments are either not available or cannot be used. Molnupiravir is in a class of medications called antivirals. It works by stopping the virus from spreading in the body..

HOW should this medicine be used?

Molnupiravir comes as a capsule to take by mouth. It is usually taken with or without food two times a day for 5 days. Take molnupiravir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take molnupiravir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

Take molnupiravir until you finish the prescription, even if you start to feel better. Do not stop taking molnupiravir without talking to your doctor. If you feel worse or develop new symptoms while taking molnupiravir, or if your COVID-19 symptoms do not start to get better, call your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking molnupiravir,

• tell your doctor and pharmacist if you are allergic to molnupiravir, any other medications, or any of the ingredients in molnupiravir tablet. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• Tell your doctor if you are pregnant or breastfeeding or plan to become pregnant or breastfeed while taking molnupiravir. Molnupiravir may cause harm to the unborn baby if used in pregnancy and is not recommended for use in pregnant women unless other treatment options are not available and it is decided with your doctor that the potential benefit outweighs the risk. Women should use a reliable birth control method during treatment with molnupiravir and for 4 days after completing therapy. Men should use contraception during treatment and for 3 months after. You may be asked to take a pregnancy test before starting molnupiravir. If you become pregnant while taking molnupiravir, call your doctor immediately. Breastfeeding is not recommended during treatment or for 4 days following treatment with molnupiravir.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you miss a dose within 10 hours of the time it is usually taken, take the missed dose as soon as you remember it. However, if you miss a dose by more than 10 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Molnupiravir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• dizziness

Molnupiravir may alter bone or cartilage growth in children and is not recommended for people less than 18 years of age. Talk to your doctor about the risks of taking this medication.

Molnupiravir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.