[Q&A] From the 26th, oral COVID-19 treatment 'Lagevrio' supply... Effects and side effects

Pre-supply of 20,000 doses from the 26th
Prohibited for pregnant women and under 18
30% effectiveness in preventing hospitalization and death

[Asia Economy Reporter Ki Ha-young] The Ministry of Food and Drug Safety has granted emergency use authorization for Merck & Company (MSD)'s oral COVID-19 treatment 'Lagevrio Capsules' (active ingredient molnupiravir), which will be supplied to infectious disease-dedicated hospitals starting from the 26th. This is the second oral COVID-19 treatment introduced domestically following Pfizer's 'Paxlovid.' However, it is prohibited for use in pregnant women and children and adolescents under 18, so caution is required.

- Who can use Lagevrio?

▲ It is used for mild to moderate adult COVID-19 patients at high risk of progressing to severe disease. Even then, it should only be used for patients who cannot use other COVID-19 treatments such as Veklury (remdesivir) or Paxlovid, or for whom other COVID-19 treatments are clinically inappropriate.

- Patients who cannot use Lagevrio and contraindicated concomitant medications

▲ Pregnant women and children and adolescents under 18 years old must not use it. Breastfeeding mothers are recommended not to breastfeed for 4 days after the last dose. Women of childbearing potential need contraception during treatment and for 4 days after the last dose, and men of childbearing potential need contraception during treatment and for 3 months after the last dose. Currently, there are no known medications that should not be used concomitantly with Lagevrio capsules due to drug interactions.

- What is the efficacy of Lagevrio?

▲ It reduces hospitalization and mortality rates in high-risk patients by about 30%. This is lower compared to Pfizer's Paxlovid, which has an efficacy of 88%. However, in situations where patient numbers are increasing and existing COVID-19 treatments are difficult to use, it can be an alternative treatment for high-risk mild to moderate patients. Gilead's remdesivir is an injectable drug, so patients cannot self-administer it, and Pfizer's Paxlovid cannot be taken by patients with liver or kidney impairment. Additionally, Paxlovid has 28 contraindicated drug components (23 components approved domestically), making many patients unable to take it.

- Why is use restricted for pregnant women and those under 18, and why is contraception recommended for a certain period?

▲ Because fetal development concerns were observed in animal studies, administration and use are restricted for pregnant women. Also, abnormalities in bone and cartilage were observed in some animal studies, so it is not administered to children and adolescents under 18. Furthermore, since the effects on children born after exposure to the drug are not confirmed, contraception is recommended as a preventive measure for a certain period. The contraception periods differ for men and women considering the drug's retention time in the body and sperm production cycle.

- Are there concerns about genotoxicity or reproductive toxicity?

▲ Some genotoxicity and reproductive toxicity tests showed fetal weight reduction and growth delay, but overall, it is not considered a genotoxic substance. Abnormalities observed in reproductive development tests can be avoided by restricting the target population. While concerns cannot be said to be zero, they are quite low and considered acceptable from a regulatory perspective.

- Were there any side effects observed during clinical trials, and are there safety concerns?

▲ Side effects observed with Lagevrio administration were mild adverse reactions such as diarrhea (1.7%), nausea (1.4%), and dizziness (1.0%). The incidence of adverse drug reactions was similar between the group administered Lagevrio and the placebo group, indicating low safety concerns.

- If side effects occur, can patients receive compensation?

▲ Patients who suffer serious harm such as hospitalization due to side effects after taking Lagevrio can apply for 'Pharmaceutical Adverse Reaction Relief.' Compensation is possible only if a causal relationship between drug intake and side effects is recognized. Applications for compensation can be submitted to the Korea Institute of Drug Safety & Risk Management with the necessary documents. Applications can be submitted in person, by mail, or via the compensation website.

- How should Lagevrio be taken?

▲ Take four capsules twice a day (every 12 hours) for a total of 5 days, regardless of meals. It should be administered as soon as possible within 5 days after testing positive for COVID-19 and symptom onset.

This content was produced with the assistance of AI translation services.