Molnupiravir

Jul 27, 2022

Generic name: molnupiravir
Dosage form: oral capsule (200 mg)
Drug class:  Miscellaneous antivirals

What is molnupiravir?

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:

  • testing positive for 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.

Warnings

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.

Before taking this medicine

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.

How should I take molnupiravir?

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.

Molnupiravir dosing information

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

Detailed Molnupiravir dosage information

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking molnupiravir?

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

Molnupiravir side effects

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.

Molnupiravir side effects  (more detail)

What other drugs will affect molnupiravir?

Other drugs may affect molnupiravir, including prescription and over-the-counter medicines,  vitamins , and  herbal products . Tell your doctor about all other medicines you use.

source :: https://www.drugs.com/molnupiravir.html