Anvisa: Molnupiravir is an oral antiviral drug that has shown beneficial effects in mild and moderate adult patients. REUTERS/Jennifer Lorenzini
The Collegiate Board of the National Health Surveillance Agency (Anvisa) this Wednesday (4) approved the emergency use of the drug molnupiravir from Merck Sharp & Dohme (MSD) for the treatment of Covid19.
Molnupiravir is an oral antiviral drug that has demonstrated beneficial effects in clinical trials in mild and moderate adult patients with the ability to reduce hospitalizations and deaths. For home use, it reduces the chances of the SarsCoV2 virus multiplying and reproducing in the body. The information comes from Agência Brasil.
The drug is already in use in 17 countries and has been approved by regulatory bodies in the United States, Europe, Japan, Great Britain, Australia and also by the World Health Organization (WHO).
Director Meiruze Freitas, rapporteur of the process, stressed the importance of therapeutic options for certain clinical conditions, especially in people who, for various reasons, are at high risk of developing severe forms of Covid19. The director warned that molnupiravir will not replace the vaccine, which remains the best option for preventing the disease.
According to Anvisa, the drug is indicated for the treatment of Covid19 in adults who do not require supplemental oxygen, who are at increased risk of the disease progressing to severe cases and whose alternative treatment options approved or approved by Anvisa are not clinically appropriate.
The drug is available for adults, by prescription, and is not recommended during pregnancy, breastfeeding, and in women of childbearing potential not using effective contraception. Laboratory studies in animals have shown that high doses of molnupiravir can impair fetal growth and development.
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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 diagnosis of the disease and within five days of the onset of symptoms.
The regulatory body informs that the drug is contraindicated in the following cases:
for use in patients under 18 years of age;
for use in pregnant women;
to initiate treatment in patients who require hospitalization, as the benefits have not been observed in individuals when treatment is started after hospitalization;
for use for more than five consecutive days;
for pre or postexposure prophylaxis for Covid19 prevention.
Anvisa also warns that molnupiravir is a drug that must be used after a doctor’s evaluation and prescription. It requires proper pharmaceutical dispensing with guidelines that the drug is for individual use and cannot be given to anyone else without a doctor’s evaluation and prescription.