Anvisa approves emergency use of drug for Covid-19

The Collegiate Board of the National Health Surveillance Agency (Anvisa) approved this Wednesday (4) the emergency use of the drug molnupiravir, from the company Merck Sharp & Dohme (MSD), for the treatment of covid-19.

Molnupiravir is an oral antiviral drug that, in clinical trials, has shown beneficial effects in mild and moderate adult patients, with the ability to reduce hospitalizations and deaths. For home use, it works to reduce the chances of the Sars-CoV-2 virus multiplying and reproducing in the body.

The drug is already in use in 17 countries and has been approved by regulatory agencies in the United States, Europe, Japan, the United Kingdom, Australia and also by the World Health Organization (WHO).

Director Meiruze Freitas, rapporteur of the process, highlighted the importance of therapeutic options for certain clinical conditions, especially in individuals who, for various reasons, are at high risk of developing severe forms of covid-19. The director warned that molnupiravir does not replace the vaccine, which remains the best option to prevent the disease.

Recommendation

According to Anvisa, the drug is indicated for the treatment of covid-19 in adults who do not require supplemental oxygen, who are at increased risk of disease progression to severe cases and whose alternative treatment options approved or authorized by Anvisa are not accessible. or clinically appropriate.

The drug is for adult use, available by prescription, and is not recommended during pregnancy, breastfeeding, and in women of childbearing potential who are not using effective contraceptives. That’s because laboratory studies in animals have shown that high doses of molnupiravir can affect fetal growth and development.

Molnupiravir should be used for the first five days after symptoms appear to prevent the development of a resistant version of the virus. Also, it should be limited to five consecutive days.

The dosage in adult patients is 800 mg (four 200 mg capsules) orally, every 12 hours, for five days, with or without food. The drug should be used as soon as possible after the disease is diagnosed and within five days of the onset of symptoms.

Contraindications

The regulatory agency clarifies that the drug is contraindicated in the following cases:

– for use in patients under 18 years of age;
– for use in pregnant women;
– for initiation of treatment in patients requiring hospitalization, as its benefits have not been observed in individuals when treatment is started after hospitalization;
– for use for more than five consecutive days;
– for pre-exposure or post-exposure prophylaxis to prevent covid-19.

Doctor’s prescription

Anvisa also warns that molnupiravir is a drug that must be used after medical evaluation and prescription. It requires adequate pharmaceutical dispensing, with guidelines that the drug is for individual use and cannot be passed on to third parties without medical evaluation and prescription.

About Abhishek Pratap

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