Molnupiravir

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

Usage of 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:

  • 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.
  • 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.

    Before taking Molnupiravir

    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.

    Relate drugs

    How to use Molnupiravir

    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

    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.

    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.

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