ot substrates for oat1, oat3, oct1, oct2, mate1, or mate2k. gs 441524 is also not a substrate for oatp1b1 or oatp1b3.

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) ].

ons (5.2) , use in specific populations (11.5) ] . determine prothrombin time in all patients before starting veklury and monitor during treatment as clinically appropriate [see overall safety summary (6.1) ] . 2.3 recommended dosage in pediatric patients 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). for pediatric patients weighing 3.5 kg to less than 40 kg, administer a body weight-based dosing regimen of veklury via intravenous (iv) infusion. the dosage should be calculated using the mg/kg dose according to the patient's weight. for pediatric patients less than 12 years of age and weighing 40 kg and higher, administer a single loading dose of veklury 200 mg on day 1 followed by once-daily maintenance doses of veklury 100 mg from day 2. refer to table 1 below for recommended dosage form and dosage in pediatric patients according to weight [see dosage and administration (2.5) , use in specific populations (11.3) ]. table 1 recommended dosage form and dosage in pediatric patients body weight recommended dosage form loading dose (on day 1) maintenance dose (from day 2) 3.5 kg to less than 40 kg veklury lyophilized powder for injection only 5 mg/kg 2.5 mg/kg 40 kg and higher 200 mg 100 mg 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. veklury for injection must be reconstituted and further diluted prior to administration via intravenous infusion. 2.4 renal impairment veklury is not recommended in pediatric patients (greater than 28 days old) with egfr less than 30 ml/min or in full-term neonates (at least 7 days and less than or equal to 28 days old) with serum creatinine greater than or equal to 1 mg/dl. 2.5 dose preparation and administration, veklury for injection the 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) only. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. discard the vial if the lyophilized powder is discolored or contains particulate matter. prior to dilution in 0.9% sodium chloride, reconstituted veklury for injection should be a clear, colorless to yellow solution, free of visible particles. care should be taken during admixture to prevent inadvertent microbial contamination. as there is no preservative or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the final parenteral solution. it is always recommended to administer intravenous medication immediately after preparation when possible. reconstitution instructions remove the required number of single-dose vial(s) from storage. for each vial: aseptically reconstitute veklury lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial. only use sterile water for injection to reconstitute veklury lyophilized powder. discard the vial if a vacuum does not pull the sterile water for injection into the vial. immediately shake the vial for 30 seconds. allow the contents of the vial to settle for 2 to 3 minutes. a clear, colorless to yellow solution, free of visible particles, should result. if the contents of the vial are not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. repeat this procedure as necessary until the contents of the vial are completely dissolved. discard the vial if the contents are not completely dissolved. following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml) of remdesivir solution. use reconstituted veklury for injection immediately to prepare the diluted solution. dilution and administration instructions, pediatric patients weighing 3.5 kg to less than 40 kg dilution instructions for pediatric patients weighing 3.5 kg to less than 40 kg, the 100 mg/20 ml (5 mg/ml) remdesivir reconstituted solution should be further diluted to a fixed concentration of 1.25 mg/ml using 0.9% sodium chloride. the final required infusion volume concentration of 1.25 mg/ml remdesivir diluted solution for infusion is based on the pediatric weight-based dosing regimens of 5 mg/kg for the loading dose and 2.5 mg/kg for each maintenance dose. small 0.9% sodium chloride infusion bags (e.g., 25, 50, or 100 ml) or an appropriately sized syringe should be used for pediatric dosing. the recommended dose is administered via intravenous infusion in a total volume dependent on the dose to yield the target remdesivir concentration of 1.25 mg/ml. a syringe and syringe pump may be used for infusion volumes less than 50 ml. refer to table 2 for recommended rate of infusion. infusion with iv bag determine the total infusion volume needed to achieve a final infusion volume concentration of 1.25 mg/ml of remdesivir diluted solution based on the patient's calculated dose. select an appropriately sized infusion bag (either prefilled with 0.9% sodium chloride or empty) to prepare veklury diluted solution. if using a prefilled 0.9% sodium chloride infusion bag, withdraw and discard the amount of diluent equal to the volume of reconstituted veklury solution needed per patient's dose plus a quantity sufficient to achieve a 1.25 mg/ml final volume concentration of remdesivir diluted solution. withdraw the required volume of reconstituted veklury solution into an appropriately sized syringe. transfer the required volume of reconstituted veklury solution to the 0.9% sodium chloride infusion bag. gently invert the bag 20 times to mix the solution in the bag. do not shake. if using an empty infusion bag, transfer the required volume of reconstituted veklury solution to the bag, followed by a volume of 0.9% sodium chloride sufficient to achieve a 1.25 mg/ml final volume concentration of remdesivir diluted solution. the prepared infusion solution is stable for 24 hours at room temperature (20°c to 25°c [68°f to 77°f]) or 48 hours at refrigerated temperature (2°c to 8°c [36°f to 46°f]). infusion with syringe determine the total infusion volume needed to achieve a final infusion volume concentration of 1.25 mg/ml of remdesivir diluted solution based on patient's calculated dose. select an appropriately sized syringe equal to or larger than the calculated total infusion volume of 1.25 mg/ml remdesivir solution needed. withdraw the required volume of reconstituted veklury solution from the vial into the syringe based on patient's calculated dose, followed by the required volume of 0.9% sodium chloride needed to achieve a 1.25 mg/ml final volume concentration of remdesivir diluted solution. gently invert the syringe 20 times to mix the solution in the syringe. do not shake. the prepared diluted solution should be used immediately. administration instructions the prepared diluted solution should not be administered simultaneously with any other medication. the compatibility of veklury with iv solutions and medications other than 0.9% sodium chloride injection, usp is not known. administer the diluted solution with the infusion rate described in table 2. table 2 recommended rate of infusion—diluted veklury for injection lyophilized powder for pediatric patients weighing 3.5 kg to less than 40 kg infusion volume infusion time rate of infusion note: rate of infusion may be adjusted based on total volume to be infused. 100 ml 30 min 3.33 ml/min 60 min 1.67 ml/min 120 min 0.83 ml/min 50 ml 30 min 1.67 ml/min 60 min 0.83 ml/min 120 min 0.42 ml/min 25 ml 30 min 0.83 ml/min 60 min 0.42 ml/min 120 min 0.21 ml/min 7 ml 30 min 0.23 ml/min 60 min 0.12 ml/min 120 min 0.06 ml/min administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. 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. dilution and administration instructions, pediatric patients less than 12 years of age and weighing 40 kg and higher dilution instructions for pediatric patients less than 12 years of age and weighing 40 kg and higher, refer to the dilution instructions in table 3. table 3 recommended dilution instructions using reconstituted veklury for injection lyophilized powder in pediatric patients less than 12 years of age and weighing 40 kg and higher veklury dose 0.9% sodium chloride infusion bag volume to be used volume to be withdrawn and discarded from 0.9% sodium chloride infusion bag required volume of reconstituted veklury for injection loading dose 200 mg (2 vials) 250 ml 40 ml 40 ml (2 × 20 ml) 100 ml 40 ml 40 ml (2 × 20 ml) maintenance dose 100 mg (1 vial) 250 ml 20 ml 20 ml 100 ml 20 ml 20 ml withdraw and discard the required volume of 0.9% sodium chloride from the infusion bag following instructions in table 3, using an appropriately sized syringe and needle. withdraw the required volume of reconstituted veklury for injection from the veklury vial following instructions in table 3. discard any unused portion remaining in the reconstituted vial. transfer the required volume of reconstituted veklury for injection to the selected infusion bag. gently invert the bag 20 times to mix the solution in the bag. do not shake. the prepared diluted solution is stable for 24 hours at room temperature (20°c to 25°c [68°f to 77°f]) or 48 hours at refrigerated temperature (2°c to 8°c [36°f to 46°f]). administration instructions the prepared diluted solution should not be administered simultaneously with any other medication. the compatibility of veklury with iv solutions and medications other than 0.9% sodium chloride injection, usp is not known. administer the diluted solution with the infusion rate described in table 4. table 4 recommended rate of infusion — diluted veklury for injection lyophilized powder in pediatric patients less than 12 years of age and weighing 40 kg and higher infusion volume infusion time rate of infusion 250 ml 30 min 8.33 ml/min 60 min 4.17 ml/min 120 min 2.08 ml/min 100 ml 30 min 3.33 ml/min 60 min 1.67 ml/min 120 min 0.83 ml/min administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. 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. 2.6 storage of prepared dosages after reconstitution, use vials immediately to prepare diluted solution. the diluted veklury solution in syringe should be used immediately. the diluted veklury solution in the infusion bags can be stored up to 24 hours at room temperature (20°c to 25°c [68°f to 77°f]) or 48 hours at refrigerated temperature (2°c to 8°c [36°f to 46°f]) prior to administration. important: this product contains no preservative. any unused portion of a single-dose veklury vial should be discarded after a diluted solution is prepared. maintain adequate records showing receipt, use, and disposition of veklury. for unused intact vials, maintain adequate records showing disposition of veklury; do not discard unused intact vials.

ot substrates for oat1, oat3, oct1, oct2, mate1, or mate2k. gs 441524 is also not a substrate for oatp1b1 or oatp1b3.

iated with untreated covid-19 in pregnancy (see clinical considerations ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk covid-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death. animal data remdesivir was administered via intravenous injection to pregnant rats and rabbits (up to 20 mg/kg/day) on gestation days 6 through 17, and 7 through 20, respectively, and also to rats from gestation day 6 to lactation/post-partum day 20. no adverse effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed in rats and rabbits at nontoxic doses in pregnant animals. during organogenesis, exposures to the predominant circulating metabolite (gs-441524) were 4 times higher (rats and rabbits) than the exposure in humans at the rhd. in a pre/postnatal development study, exposures to the predominant circulating metabolite of remdesivir (gs-441524) were similar to the human exposures at the rhd. 11.2 lactation risk summary there are no available data on the presence of remdesivir in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies, remdesivir and metabolites have been detected in the nursing pups of mothers given remdesivir, likely due to the presence of remdesivir in milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for veklury and any potential adverse effects on the breastfed child from veklury or from the underlying maternal condition. breastfeeding individuals with covid-19 should follow practices according to clinical guidelines to avoid exposing the infant to covid-19. animal data remdesivir and its metabolites were detected in the plasma of nursing rat pups, likely due to the presence of remdesivir and/or its metabolites in milk, following daily intravenous administration of remdesivir to pregnant rats from gestation day 6 to lactation day 20. exposures in nursing pups were approximately 1% that of maternal exposure on lactation day 10. 11.3 pediatric use the safety and effectiveness of veklury have not been established 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, and 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 for injection (supplied as 100 mg lyophilized powder in vial) [see dosage and administration (2.2 , 2.3 , 2.4 , 2.5) ] is the only authorized dosage form of veklury for pediatric patients in this age group. use in this age group is based on extrapolation of pediatric efficacy from adequate and well-controlled studies in adults [see overall safety summary (6) , clinical pharmacology (14) , clinical trial results and supporting data for eua (18) ]. pediatric patients (older than 28 days) must have egfr determined and full-term neonates (at least 7 days to less than or equal to 28 days) must have serum creatinine determined before dosing and daily while receiving veklury. pediatric patients should be monitored for renal function and consideration given for stopping therapy in the setting of substantial decline [see dosage and administration (2.2 , 2.4) ]. 11.4 renal impairment the pharmacokinetics of veklury have not been evaluated in patients with renal impairment. patients with egfr greater than or equal to 30 ml/min have received veklury for the treatment of covid-19 with no dose adjustment of veklury. pediatric patients (greater than 28 days old) must have egfr determined and full-term neonates (at least 7 days to less than or equal to 28 days old) must have serum creatinine determined before dosing and while receiving veklury. veklury is not recommended in pediatric patients (at least 28 days old) with egfr less than 30 ml/min or in full-term neonates (at least 7 days and less than or equal to 28 days old) with serum creatinine greater than or equal to 1 mg/dl [see dosage and administration (2.2 , 2.4) ]. 11.5 hepatic impairment the pharmacokinetics of veklury have not been evaluated in patients with hepatic impairment [see warnings and precautions (5.2) ]. perform hepatic laboratory testing in all patients before starting veklury and during treatment as clinically appropriate [see dosage and administration (2.2) ] .

pregnancy (see clinical considerations ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo-fetal risk covid-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death. animal data remdesivir was administered via intravenous injection to pregnant rats and rabbits (up to 20 mg/kg/day) on gestation days 6 through 17, and 7 through 20, respectively, and also to rats from gestation day 6 to lactation/post-partum day 20. no adverse effects on embryo-fetal (rats and rabbits) or pre/postnatal (rats) development were observed in rats and rabbits at nontoxic doses in pregnant animals. during organogenesis, exposures to the predominant circulating metabolite (gs-441524) were 4 times higher (rats and rabbits) than the exposure in humans at the rhd. in a pre/postnatal development study, exposures to the predominant circulating metabolite of remdesivir (gs-441524) were similar to the human exposures at the rhd.

t least 7 days to less than or equal to 28 days) must have serum creatinine determined before dosing and daily while receiving veklury. pediatric patients should be monitored for renal function and consideration given for stopping therapy in the setting of substantial decline [see dosage and administration (2.2 , 2.4) ].

na synthesis with an ic 50 value of 0.032 µm. rdv-tp can also inhibit viral rna synthesis following its incorporation into the template viral rna as a result of read-through by the viral polymerase that may occur at higher nucleotide concentrations. when remdesivir nucleotide is present in the viral rna template, the efficiency of incorporation of the complementary natural nucleotide is compromised, thereby inhibiting viral rna synthesis. remdesivir triphosphate is a weak inhibitor of mammalian dna and rna polymerases, including human mitochondrial rna polymerase. 14.2 pharmacokinetics the pharmacokinetic (pk) properties of remdesivir and metabolites have been evaluated in adults in several phase 1 trials and are provided in table 12. the multiple dose pk parameters of remdesivir and metabolites in healthy adults are provided in table 13. table 12 pharmacokinetic properties of remdesivir and metabolites (gs-441524 and gs-704277) in adults remdesivir gs-441524 gs-704277 nd=not detected absorption t max (h) remdesivir administered as a 30-minute iv infusion (study gs-us-399-5505); range of median observed on day 1 and day 5 or 10. 0.67–0.68 1.51–2.00 0.75–0.75 distribution % bound to human plasma proteins 88–93.6 range of protein binding for remdesivir from 2 independent experiments show no evidence of concentration-dependent protein binding for remdesivir. 2 1 blood-to-plasma ratio 0.68–1.0 1.19 0.56 elimination t 1/2 (h) median (study gs-us-399-4231). 1 27 1.3 metabolism metabolic pathway(s) ces1 (80%) cathepsin a (10%) cyp3a (10%) not significantly metabolized hint1 excretion major route of elimination metabolism glomerular filtration and active tubular secretion metabolism % of dose excreted in urine mean (study gs-us-399-4231). 10 49 2.9 % of dose excreted in feces nd 0.5 nd table 13 multiple dose pk parameters remdesivir administered as a 30-minute iv infusion (study gs-us-399-5505). of remdesivir and metabolites (gs-441524 and gs-704277) following iv administration of veklury 100 mg to healthy adults parameter mean (cv%) remdesivir gs-441524 gs-704277 cv=coefficient of variation; nd=not detectable (at 24 hours post-dose) c max (nanogram per ml) 2229 (19.2) 145 (19.3) 246 (33.9) auc tau (nanogram∙h per ml) 1585 (16.6) 2229 (18.4) 462 (31.4) c trough (nanogram per ml) nd 69.2 (18.2) nd specific populations pharmacokinetic differences based on sex, race, and age have not been evaluated. the pharmacokinetics of veklury in pediatric patients have not been evaluated. using modeling and simulation, the recommended dosing regimen is expected to result in comparable steady-state plasma exposures of remdesivir and metabolites 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 as observed in healthy adults.

cyp3a (10%) not significantly metabolized hint1 excretion major route of elimination metabolism glomerular filtration and active tubular secretion metabolism % of dose excreted in urine mean (study gs-us-399-4231). 10 49 2.9 % of dose excreted in feces nd 0.5 nd table 13 multiple dose pk parameters remdesivir administered as a 30-minute iv infusion (study gs-us-399-5505). of remdesivir and metabolites (gs-441524 and gs-704277) following iv administration of veklury 100 mg to healthy adults parameter mean (cv%) remdesivir gs-441524 gs-704277 cv=coefficient of variation; nd=not detectable (at 24 hours post-dose) c max (nanogram per ml) 2229 (19.2) 145 (19.3) 246 (33.9) auc tau (nanogram∙h per ml) 1585 (16.6) 2229 (18.4) 462 (31.4) c trough (nanogram per ml) nd 69.2 (18.2) nd specific populations pharmacokinetic differences based on sex, race, and age have not been evaluated. the pharmacokinetics of veklury in pediatric patients have not been evaluated. using modeling and simulation, the recommended dosing regimen is expected to result in comparable steady-state plasma exposures of remdesivir and metabolites 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 as observed in healthy adults.

imes the exposure in humans at the rhd. animal toxicology and/or pharmacology intravenous administration (slow bolus) of remdesivir to male rhesus monkeys at dosage levels of 5, 10, and 20 mg/kg/day for 7 days resulted, at all dose levels, in increased mean urea nitrogen and increased mean creatinine, renal tubular atrophy, and basophilia and casts. intravenous administration (slow bolus) of remdesivir to rats at dosage levels of ≥3 mg/kg/day for up to 4 weeks resulted in findings indicative of kidney injury and/or dysfunction. kidney-related effects in rats and monkeys were observed at exposures of the predominant circulating metabolite (gs-441524) that are lower than the exposure in humans at the rhd.

e diluted veklury solution in the infusion bags can be stored up to 24 hours at room temperature (20°c to 25°c [68°f to 77°f]) or 48 hours at refrigerated temperature (2°c to 8°c [36°f to 46°f]) prior to administration.

(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. this fact sheet contains information to help you understand the risks and benefits of your child receiving veklury. the fda has issued an eua to make veklury available for this use during the covid-19 pandemic (for more details about an eua please see " what is an emergency use authorization? " at the end of this document). veklury is not approved for use as treatment for covid-19 for the pediatric population covered under this eua. read this fact sheet for information about veklury. talk to your healthcare provider about your options or if you have any questions. it is your choice for your child to receive veklury or stop it at any time. what is covid-19? covid-19 is caused by a virus called a coronavirus. you can get covid-19 through close contact with another person who has the virus. covid-19 illnesses have ranged from very mild to severe, including illness with no reported symptoms and illness resulting in death. while information so far suggests that most covid-19 illness is mild, serious illness can happen and may cause some of a child's other medical conditions to become worse. older people and people of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, seem to be at higher risk of being hospitalized for covid-19. what is veklury? veklury is a prescription medicine that is investigational for use for the treatment of covid-19 in children weighing 8 pounds (3.5 kg) to less than 88 pounds (40 kg) or children less than 12 years of age weighing at least 8 pounds (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 is investigational for this use because it is still being studied and there is limited information about the safety and effectiveness of using veklury for the treatment of covid-19 in this population. veklury is an fda-approved prescription medicine used to treat covid-19 in adults and children (12 years of age and older and weighing at least 88 pounds (40 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 at high risk for progression to severe covid-19, including hospitalization or death. what should i tell my healthcare provider before my child receives veklury? tell your healthcare provider about all of your child's medical conditions, including if your child: has any allergies has kidney or liver disease has any serious illnesses tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. veklury may interact with other medicines and may cause serious side effects. especially tell your healthcare provider if your child is taking the medicines chloroquine phosphate or hydroxychloroquine sulfate. how will my child receive veklury? hospitalized: veklury is given to your child through a vein by intravenous (iv) infusion one time each day for up to 10 days. your healthcare provider will decide how many doses your child needs. not hospitalized: veklury is given to your child through a vein by intravenous (iv) infusion one time each day for 3 days. your healthcare provider will do certain blood tests before starting and during treatment with veklury. who should generally not receive veklury? your child should not receive veklury if your child is allergic to remdesivir or any of the ingredients in veklury. what are the important possible side effects of veklury? possible side effects of veklury are: allergic reactions . allergic reactions can happen during and after infusion with veklury. your healthcare provider will monitor your child for signs and symptoms of allergic reactions during their infusion and for at least 1 hour after their infusion. tell your healthcare provider right away if your child gets any of the following signs and symptoms of allergic reactions: changes to heart rate fever shortness of breath or wheezing shivering swelling of the lips, face, or throat rash nausea sweating increases in levels of liver enzymes. increases in liver enzymes are common in people who have received veklury and may be a sign of liver injury. your healthcare provider will do blood tests to check your child's liver enzymes before receiving veklury and as needed while receiving veklury. your healthcare provider may stop treatment with veklury if your child develops liver problems. the most common side effect of veklury is nausea. these are not all the possible side effects of veklury. veklury is still being studied so it is possible that all of the risks are not known at this time. what other treatment choices are there? like veklury, fda may allow for the emergency use of other medicines to treat people with covid-19. go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are not approved by the fda to treat people with covid-19. your healthcare provider may talk with you about clinical trials your child may be eligible for. it is your choice for your child to be treated or not to be treated with veklury. should you decide for your child not to receive it, it will not change your child's standard medical care. how do i report side effects with veklury? contact your healthcare provider if your child has any side effect that bothers them or does not go away. report side effects to fda medwatch at www.fda.gov/medwatch or call 1-800-fda-1088 and to gilead by calling 1-800-445-3235. how can i learn more about covid-19? ask your healthcare provider. visit https://www.cdc.gov/covid19. contact your local or state public health department. what is an emergency use authorization (eua)? the united states fda has made veklury available under an emergency access mechanism called an emergency use authorization (eua) for the treatment of coronavirus disease 2019 (covid-19) in children weighing 8 pounds (3.5 kg) to less than 88 pounds (40 kg) or children less than 12 years of age weighing at least 8 pounds (3.5 kg), with positive results of direct severe acute respiratory syndrome coronavirus 2 (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 eua is supported by a secretary of health and human service (hhs) declaration that circumstances exist to justify the emergency use of drugs and biological products during the covid-19 pandemic. veklury for the authorized use has not undergone the same type of review as an fda-approved product. in issuing an eua under the covid-19 public health emergency, the fda has determined, among other things, that based on the total amount of scientific evidence available including data from adequate and well controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing covid-19, or a serious or life threatening disease or condition caused by covid-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives. all of these criteria must be met to allow for the product to be used in the treatment of the authorized patient population during the covid-19 pandemic. the eua for veklury is in effect for the duration of the covid-19 declaration justifying emergency use of veklury, unless terminated or revoked (after which veklury may no longer be used under the eua). © 2022 gilead sciences, inc. all rights reserved. revised: 01/2022