FDA label 31ef52f8-267b-4c45-a8b0-84230fd10b89

This EUA is for the use of VEKLURY to treat COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg, 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. VEKLURY must be administered by intravenous (IV) infusion. Healthcare providers must submit a report on all medication errors and ALL SERIOUS ADVERSE EVENTS related to VEKLURY. See Sections 8 and 9 of the Full EUA Prescribing Information for reporting requirements. See the Full EUA Prescribing Information for complete dosage, preparation, and administration instructions. The only authorized dosage form of VEKLURY for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg is VEKLURY for injection (supplied as 100 mg lyophilized powder in vial). The recommended dosage for pediatric patients weighing 3.5 kg to less than 40 kg is a single loading dose of VEKLURY 5 mg/kg on Day 1 followed by VEKLURY 2.5 mg/kg once daily from Day 2 [see Full EUA Prescribing Information, Recommended Dosage in Pediatric Patients (2.3) ]. The recommended dosage for pediatric patients less than 12 years of age and weighing 40 kg and higher is a single loading dose of 200 mg on Day 1 followed by once-daily maintenance doses of 100 mg from Day 2. Hospitalized patients : The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made. The recommended total treatment duration for hospitalized patients requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) is 10 days. The recommended treatment duration for hospitalized patients not requiring invasive mechanical ventilation and/or ECMO 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. 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. The recommended total treatment duration for non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, is 3 days. Administer VEKLURY via intravenous infusion over 30 to 120 minutes. For information on clinical trials that are testing the use of VEKLURY in COVID-19, please see www.clinicaltrials.gov.

5. WARNINGS AND PRECAUTIONS There are limited clinical data available for VEKLURY in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg. Serious and unexpected adverse events may occur that have not been previously reported with VEKLURY use. 5.1 Hypersensitivity Including Infusion-Related and Anaphylactic Reactions Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of VEKLURY; most occurred within one hour. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment. The use of VEKLURY is contraindicated in patients with known hypersensitivity to VEKLURY or any components of the product [see Contraindications (4) ] . 5.2 Increased Risk of Transaminase Elevations Transaminase elevations have been observed in healthy volunteers who received 200 mg of VEKLURY followed by 100 mg doses for up to 10 days; the transaminase elevations were mild (Grade 1) to moderate (Grade 2) in severity and resolved upon discontinuation of VEKLURY. Transaminase elevations have also been reported in patients with COVID-19 who received VEKLURY. Because transaminase elevations have been reported as a clinical feature of COVID-19, including in patients receiving placebo in clinical trials of VEKLURY, and the incidence was similar in patients receiving placebo versus VEKLURY in clinical trials of VEKLURY, discerning the contribution of VEKLURY to transaminase elevations in patients with COVID-19 can be challenging. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate. Consider discontinuing VEKLURY if ALT levels increase to greater than 10 times the upper limit of normal. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation. 5.3 Risk of Reduced Antiviral Activity When Coadministered with Chloroquine Phosphate or Hydroxychloroquine Sulfate Coadministration of VEKLURY and chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments demonstrating a potential antagonistic effect of chloroquine on the intracellular metabolic activation and antiviral activity of VEKLURY [see Drug Interactions (10) , Microbiology/Resistance Information (15) ].