Molnupiravir – Here’s What You Need to Know About the First Oral COVID-19 Drug [EXPLAINED]

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The first oral drug for COVID-19 is now available in Poland. The Ministry of Health informed that the product has received a marketing authorization and may be legally distributed in our country. Who is the anti-coronavirus drug for? What are the contraindications to its use? When and in what dose should it be taken? What are the side effects of molnupiravir?

1. Molnupiravir (Lagevrio) is an antiviral drug that can reduce the need for COVID-19 hospitalization in people at high risk by up to 50%.
2. The drug has not yet been authorized in the European Union, but is available, for example, in the United Kingdom. Therefore, the European Medicines Agency (EMA) recommends its use in the treatment of adults with COVID-19 who are at risk of severe disease and do not require oxygen therapy
3. The first shipment of molnupiravir to Poland, containing 5,6 thousand. packaging of molnupiravir, it was delivered on December 17.
4. The product can be ordered by both hospitals and health care facilities
5. More information can be found on the TvoiLokony home page

Where did molnupiravir come from in the treatment of COVID-19?

Molnupiravir is a substance that inhibits the replication of some RNA viruses. The antiviral drug based on this substance in the form of oral capsules was originally developed in 2018. At that time, no one suspected that the world would soon be overwhelmed by a new infectious disease caused by an extremely dangerous virus. So researchers at Emory University in the United States were working on a drug that would help treat flu.

After the outbreak of the pandemic, in March 2020, research began on the use of the developed preparation in the treatment of people suffering from COVID-19. The results turned out to be successful. In October 2021, it was shown that treatment with molnupiravir in high-risk patients reduces the risk of hospitalization and death from coronavirus infection by approximately 50%.

Is molnupiravir officially authorized?

The drug has not yet been fully approved by the EMA, but has received positive feedback from it. It aims to support national governments in deciding to introduce the preparation as a treatment for COVID-19, especially in the face of the growing number of infections and deaths. This is why some countries, like Poland, have decided to enter it into the national registers of medicinal products.

The first to do so was Great Britain, where molnupiravir is available under the name Lagevrio. The approval of the drug on the market in this country, as well as the EMA recommendation, prompted our Ministry of Health to include molnupiravir in the group of drugs used in the treatment of COVID-19.

«(…) The Minister of Health took steps to ensure the availability of the product for patients treated in Poland, authorizing for a limited period (…) the medicinal product Lagevrio, molnupiravir, hard capsules a 200 mg, MA: Merck Sharp & Dohme (UK) Limited , manufacturer: Merck Sharp & Dohme BV Waarderweg 39 2031 BN Haarlem The Netherlands. Meaning that this product has a marketing authorization and can be legally distributed in Poland»- the Ministry of Health informed in a statement of February 9.

COVID-19 drug – form and composition

Lagevrio is available as orange hard capsules, each containing 200 mg of molnupiravir. In addition to the active substance, the composition includes croscarmellose sodium (E468), hydroxypropyl cellulose (E463), magnesium stearate (E470b) and microcrystalline cellulose (E460). The package (glass bottle) contains 40 capsules of the drug.

The rest of the text below the video.

Molnupiravir – indications and contraindications for use

Molnupiravir is indicated for the treatment of mild to moderate COVID-19 in people with at least one risk factor for developing severe disease. What are the risk factors?

Patients have the priority in administering the drug:

1. treated for cancer, 
2. dialysis for kidney failure, 
3. recent organ transplant, taking immunosuppressive drugs,
4. up to two years after stem cell transplant,
5. suffering from moderate or severe immunodeficiency (e.g. DiGeorge syndrome or Wiskott-Aldrich syndrome), 
6. HIV infected,
7. taking high doses of drugs that suppress the immune response.

At the same time, groups of people were indicated who should not use molnupiravir, because the active substance or another component of the drug may cause an allergic reaction in them or significantly affect the functioning of other organs. It is also about people in the age group that has not been included in clinical trials, i.e. children and adolescents.

Kto nie powinien stosować leku Lagevrio?

1. people who are hypersensitive to the active substance or to any of the excipients,
2. pregnant women,
3. breastfeeding women,
4. persons under the age of 18.

When it comes to pregnant women, animal studies have shown that molnupiravir may have adverse effects on reproduction. Therefore, women of childbearing potential who are taking Lagevrio should use effective protection against pregnancy throughout treatment and for four days after treatment.

Similar animal studies have not been conducted in the context of breastfeeding, therefore the manufacturer does not recommend the use of the drug to women who give their children their own food. “Considering the potential for side effects in an infant with Lagevrio, breastfeeding is not recommended during treatment and for four days after the last dose of Lagevrio” as indicated in the SmPC.

Lagevrio – dosage

It is recommended to use the drug after four capsules twice a day at 12-hour intervals for five consecutive days.

What is important, molnupiravir should be administered as soon as COVID-19 is diagnosed within the first five days of onset of symptoms. This is the time when the coronavirus multiplies and is the most in the body. After this time, treatment with molnupiravir may not be as effective as at the beginning of the infection.

What side effects might a coronavirus drug have?

During clinical trials, 12,4% reported adverse reactions during or after treatment with molnupiravir. patients. The four most common side effects of the drug were diarrhea (3,1%), nausea (2,3%), dizziness (1,3%) and headache (1%). These symptoms occurred while taking the drug or within 14 days after the last dose and were mild or moderate in nature.

At the same time, no interactions of other drugs with molnupiravir have been demonstrated. The manufacturer has not conducted adequate clinical studies, but – as stated in the leaflet – the available knowledge about the drug’s mechanisms of action and in vitro studies suggest that such an interaction is unlikely.

What drugs are used in Poland to treat COVID-19?

The spokesman for the Ministry of Health, Wojciech Andrusiewicz, said in an interview with PAP that Poland participates in tenders for all COVID-19 drugs that the European Union will buy. It goes, among others o Ronapreve and Regkiron, which EMA approved for trading in Europe in the first half of November. These drugs, administered in the early stages of coronavirus infection, are expected to significantly reduce the risk of hospitalization and the severe course of the disease.

Currently in Poland, patients with COVID-19 are administered, inter alia, Tocilizumab, Remdesivir and Baricitinib. The latter appeared in hospitals only during the fourth wave of the pandemic and is used in the moderate to severe course of SARS-CoV-2 infection.

1. See also: EMA has approved two new drugs for COVID-19. How do they work and when can they help?

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