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On April 25, 2022, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
The only approved dosage form of Veklury for pediatric patients weighing 3 kg to less than 40 kg is Veklury for injection (supplied as 100 mg lyophilized powder in vial). The recommended dosage of Veklury is:
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Adults and pediatric patients weighing at least 40 kg: a single loading dose of Veklury 200 mg on Day 1 followed by once-daily maintenance doses of Veklury 100 mg from Day 2 via intravenous infusion.
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Pediatric patients 28 days of age and older and weighing 3 kg to less than 40 kg: a single loading dose of Veklury 5 mg/kg on Day 1 followed by once-daily maintenance doses of Veklury 2.5 mg/kg from Day 2 via intravenous infusion.
For hospitalized patients, the treatment course of Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.
For non-hospitalized patients, the treatment course of Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within 7 days of symptom onset. For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID19, including hospitalization or death, the recommended total treatment duration is 3 days.
All pediatric patients 28 days of age and older and weighing at least 3 kg must have eGFR determined before starting Veklury and while receiving Veklury as clinically appropriate. Veklury is not recommended in patients with eGFR less than 30 mL/min. Refer to the full prescribing information for further details on dose preparation and administration.
Pharmacokinetics in Pediatric Patients
Population pharmacokinetic models for remdesivir and its circulating metabolites (GS-704277 and GS-441524), developed using pooled data from studies in healthy subjects and in adult and pediatric patients with COVID-19, were used to estimate pharmacokinetic exposures in pediatric patients aged ≥28 days to <18 years and weighing ≥3 kg. Geometric mean estimated exposures (AUCtau, Cmax, and Ctau) for these patients at the doses administered were higher for remdesivir (33% to 129%), GS-441524 (0% to 60%), and GS-704277 (37% to 124%) as compared to those in adult patients with COVID-19; however, the increases were not considered clinically significant.
Efficacy and Safety
Efficacy
Given the similar course of COVID-19 disease in adults and pediatric patients, the approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. This approval is also supported by a phase 2/3, single-arm, open-label clinical study of 53 pediatric patients at least 28 days of age and weighing at least 3 kilograms (about 7 pounds) with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19. Patients in this pediatric phase 2/3 trial received Veklury for up to 10 days. The safety and pharmacokinetic results from the phase 2/3 study in pediatric subjects were similar to those in adults.
Safety
Possible side effects of using Veklury include increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.
The safety and effectiveness of Veklury have not been established in pediatric patients younger than 28 days of age or weighing less than 3 kg.
Additional Information
Full prescribing information for Veklury is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214787s011lbl.pdf.
Veklury is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended. The FDA has approved two vaccines, and three vaccines are available for emergency use, to prevent COVID-19 and the serious clinical outcomes associated with COVID-19, including hospitalization and death. The FDA urges the public to get vaccinated and receive a booster when eligible. Learn more about FDA-approved and authorized COVID-19 vaccines.
Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at https://www.fda.gov/safety/medwatch/default.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
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