[Q&A on pills for COVID-19] Do I need to get contraception if I take "Lagebrio?

The Ministry of Food and Drug Safety approved the emergency use of the nation's second new coronavirus infection (COVID-19) oral treatment "Lagebrio" on the 23rd.

 

Ragebrio, developed by Merck in the United States, is prescribed to patients with high-risk mild to moderate symptoms who cannot take the existing drug "Pax Robide" or are difficult to use injections. It is taken twice (every 12 hours) for five days, 800mg (4 capsules) a day, and should be administered as soon as possible within five days after being diagnosed positive for COVID-19.

 

Ragebrio's explanation and precautions announced by the Ministry of Food and Drug Safety were organized in the form of question and answer.

 

Q. Can children or adolescents take Ragebrio?

A. Ragebrio cannot be used for pregnant women under the age of 18. In addition, lactation is not recommended for the duration of administration of this drug and for 4 days after the last administration.

Women in childbearing age need contraception during administration and for 4 days after the last administration, and men in childbearing age should be contraceptive for 3 months during administration and after the last administration.

 

Q. Is it possible for patients who cannot use paxlovide due to combination contraindications?

A. Drugs that should not be used in conjunction with drug interactions with Ragebrio have not been known to date. The Ministry of Food and Drug Safety believes that Ragebrio can be an alternative to treatment for high-risk mild to moderate patients who have difficulty using paxlovid. This includes patients with severe liver and kidney disorders and patients taking 23 combination contraindicated drugs.

 

Q. Have you obtained approval from advanced countries such as the United States and Europe?

A. Ragebrio has been granted conditional permission or approval for emergency use in 15 countries including the United Kingdom, the United States and Japan. The UK was the first to conditionally approve the market in November last year, and the United States decided to approve emergency use in December. In the same month, Japan also granted special approval. In addition, it has obtained approval for emergency use in Mexico, Taiwan, and Thailand.

 

Q. Were there any side effects or adverse reactions in the clinical trial?

A. Side effects observed when administering Ragebrio were mild adverse reactions such as diarrhea (1.7%), nausea (1.4%), and dizziness (1.0%). The Ministry of Food and Drug Safety judged that safety concerns were low because the incidence of adverse drug reactions in the test group and placebo group was similar.

 

Q. Clinical trials show that the treatment effect is only 30%.

A. Although 30% is not a high effect, it can be an alternative to treatment for patients who cannot use Paxlovid or injections (Beckluris). The emergency use approval was decided to provide treatment alternatives to high-risk patients.

 

Q. Can I be compensated for side effects after taking Ragevrio?

A. Patients who have suffered serious damage such as hospitalization treatment due to side effects after taking them may apply to the government for "relief of side effects of medicines." Compensation is possible if causality between drug use and side effects is recognized. You can visit, mail, or submit an application for damage compensation to the Korea Pharmaceutical Safety Management Institute.