Through a statement, the United States Food & Drug Administration (FDA) informed that it extended the approval of the remdesivir (Veklury treatment) for coronavirus to include certain pediatric populations. This treatment does not replace the application of vaccines or booster doses.
Who are the new people who will be able to receive this treatment with remdesivir? Here we tell you.
FDA expands use of remdesivir for the pediatric population: what you should know
In its releasethe FDA points out that the expansion of remdesivir it will be for the following populations to be included:
- Little 28 days old
- Seniors who weigh at least 3 kilograms (about 7 pounds) with positive SARS-CoV-2 viral tests and who meet the following statuses:
- hospitalized
- Not hospitalized and with a mild to moderate infection, but at high risk of progression to severe covid, including hospitalization or death
It should be noted that until now, treatment with remdesivir It was only approved for the treatment of pediatric patients 12 years of age and older weighing 40 kilograms and certain adults, all of whom had COVID-19 infection.
Therefore, the FDA points out that the expansion of the use of remdesivir makes the treatment the first approved for small minors 12 years old. This action revokes the prior emergency use authorization for coverage of this pediatric population.
Today we expanded approval of the #COVID19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms. This marks the first approved #COVID19 treatment for children younger than 12.
Learn more: https://t.co/d4gRfh1chd pic.twitter.com/WML2gxJlzy
— USFDA (@US_FDA) April 25, 2022
“Coronavirus can cause serious illness in children, some of whom currently do not have an option to receive vaccines. Therefore, there remains a need for safe and effective infection treatment options for this population. The approved treatment with remdesivir It’s one of these options.” said the director of FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni.
Remdesivir Side Effects
Contraindications
The only contraindication for use is the “hypersensitivity of the patient to the active ingredient or to any of the drug’s excipients (sodium betadex sulfobutylether, hydrochloric acid or sodium hydroxide)”, as reported by experts.
Precisely because of this, “the use of remdesivir is limited to health centers in which patients can be adequately controlled”. Signs and symptoms of hypersensitivity reactions may include “hypotension, hypertension, tachycardia, bradycardia, hypoxia, pyrexia, respiratory distress, rash, chills, wheezing, angioedema, nausea, vomiting, and/or excessive sweating”.
To prevent its appearance, “Intravenous infusion at a slower rate may be considered to prevent these signs and symptoms but should be discontinued immediately if they occur.”
In addition to this there are several situations in which the use of remdesivir should be done with great caution:
- Liver failure: since elevations of transaminases have been observed in clinical trials with remdesivir, which included healthy volunteers and patients with Covid-19. Liver function should be determined in all patients before starting treatment and while it lasts. have not been made Clinical studies with remdesivir in patients with hepatic insufficiency. Remdesivir should only be used in patients with liver failure if the potential benefit outweighs the potential risk.
Remdesivir should be discontinued in patients who experience:
- Alanine aminotransferase (ALT) ALT ≥5 times the upper limit of normal during the remdesivir treatment. Remdesivir can be resumed when ALT is <5 times the upper limit of normal.
- ALT elevation along with signs or symptoms of liver inflammation or increased conjugated bilirubin, alkaline phosphatase, or INR.
Besides, “Co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommendedbased on previous studies that suggest an antagonistic effect of chloroquine on intracellular metabolic activation and the antiviral activity of remdesivir”, add the experts from the COF General Council.
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