Veklury

Composition: See Table 1.

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Product Description: See Table 2.

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Physicochemical Properties: Nonproprietary name: Remdesivir.
Chemical name: 2-Ethylbutyl N-{(S)-[2-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,5-anhydro-D-altrononitril-6-O-yl]phenoxyphosphoryl}-L-alaninate.
Molecular formula: C₂₇H₃₅N₆O₈P.
Molecular weight: 602.58.
Description: White to off-white or yellow solid.
Solubility: It is freely soluble in methanol, and tetrahydrofuran, soluble in ethanol, and slightly soluble in isopropyl acetate.
Melting point: 138°C.
Partition coefficient: log P=3.2.

Pharmacology: Mechanism of Action: Remdesivir is an adenosine analog nucleotide prodrug that distributes intracellularly and is metabolized successively by hydrolysis and ultimately phosphorylation to the pharmacologically active triphosphate form of nucleoside analogue. The pharmacologically active metabolite acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. The inhibition (IC₅₀ values) by the pharmacologically active metabolite was >200 μM on human DNA polymerases α and β, RNA polymerase II, mitochondrial DNA polymerase γ and mitochondrial RNA polymerase.
In vitro Anti-viral Activity: Remdesivir exhibited cell culture antiviral activity against a clinical isolate of SARS-CoV-2 in primary human airway epithelial (HAE) cells with a 50% effective concentration (EC₅₀) of 9.9 nM after 48 hours of treatment. Remdesivir inhibited the replication of SARS-CoV-2 in the continuous human lung epithelial cell lines Calu-3 and A549-hACE2 with EC₅₀ values of 280 nM after 72 hours of treatment and 115 nM after 48 hours of treatment, respectively.
Remdesivir EC₅₀ fold change values against clinical isolates of SARS-CoV-2 variants containing the Nsp12 amino acid substitution at P323L in the viral RNA-dependent RNA polymerase including Alpha (lineage B.1.1.7), Beta (lineage B.1.351), Delta (lineage B.1.617.2), Gamma (lineage P.1), and Epsilon (lineage B.1.429) were 0.4- to 1.5-fold compared to earlier lineage SARS-CoV-2 (lineage A) by plaque assay and/or N protein ELISA assay.
Drug Resistance: No clinical data are available on the development of SARS-CoV-2 resistance to remdesivir. SARS-CoV-2 isolates with reduced susceptibility to remdesivir have been selected in cell culture. In one selection with GS-441524, the nucleoside analogue which is a metabolite of remdesivir, Nsp12 amino acid substitutions at V166A, N198S, S759A, V792I, C799F, and C799R were identified as resistance variants to remdesivir. In recombinant SARS-CoV-2 with each substitution introduced individually, 1.7- to 3.5-fold reduced susceptibility to remdesivir was observed. In a second selection with remdesivir using a SARS-CoV-2 isolate containing the Nsp12 amino acid substitution at P323L, a single Nsp12 amino acid substitution at V166L was identified. Recombinant SARS-CoV-2 with substitutions at P323L alone or P323L+V166L in combination exhibited 1.3- and 1.5-fold changes in remdesivir susceptibility, respectively.
In vitro resistance profiling of remdesivir using the rodent CoV murine hepatitis virus identified 2 substitutions (F476L and V553L) in the viral RNA-dependent RNA polymerase at residues conserved across CoVs that conferred a 5.6-fold reduced susceptibility to remdesivir. The mutant viruses showed reduced viral fitness in vitro and introduction of the corresponding substitutions (F480L and V557L) into SARS-CoV resulted in 6-fold reduced susceptibility to remdesivir in cell culture and attenuated SARS-CoV pathogenesis in a mouse model. When individually introduced into the Nsp12 substitution recombinant SARS-CoV-2, the corresponding substitutions at F480L and V557L each conferred 2-fold reduced susceptibility to remdesivir.
Therapeutic Effects in Animal Models: Remdesivir showed antiviral activity in SARS-CoV-2-infected rhesus monkeys. Administration of remdesivir at 10/5 mg/kg (10 mg/kg first dose, followed by 5 mg/kg once daily thereafter) using IV bolus injection initiated 12 hours post-inoculation with SARS-CoV-2 resulted in a reduction in clinical signs of respiratory disease, lung pathology and gross lung lesions, and lung viral RNA levels compared with vehicle-treated animals.
Clinical Studies: Clinical Studies for Efficacy and Safety: Global Phase III study: NIAID ACTT-1 Study (NCT04280705): A placebo-controlled, randomized, double-blind, parallel-group clinical trial was conducted in patients aged ≥18 years with SARS-CoV-2 infection. They received remdesivir 200 mg IV once daily on Day 1 followed by remdesivir 100 mg IV once daily on Days 2 to 10 or placebo. If the subject was discharged from the hospital, the study drug was discontinued. In addition to study drug, standard of care was allowed in accordance with local guidelines for the treatment of infections with SARS-CoV-2. The primary endpoint was time to recovery within 28 days after randomization (score of 1 to 3 on 8-point ordinal scale Note 1)). In results of the primary endpoint, the median time to recovery was 10 days in the remdesivir group and 15 days in the placebo group, showing a statistically significant difference between remdesivir group and the placebo group in pairwise comparisons. (hazard ratio 1.29; 95% CI 1.12 to 1.49, p<0.001, stratified log-rank test). (See Figure.)

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The key inclusion and exclusion criteria of this study were as shown in the following table. (See Table 3.)

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Adverse reactions ^{note 2)} in remdesivir treatment group were reported in 8% of subjects (41/532 subjects) and the most common adverse reaction was increased prothrombin time at 2% (9/532 subjects)).
Note 1) 8-point ordinal scale [Score 1: Not hospitalized, no limitation on activities, Score 2: Not hospitalized, limitation on activities and/or requiring home oxygen, Score 3: Hospitalized, not requiring supplemental oxygen – no longer required ongoing medical care, Score 4: Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise), Score 5: Hospitalized, requiring supplemental oxygen, Score 6: Hospitalized, on noninvasive ventilation or high-flow oxygen devices, Score 7: Hospitalized, on ECMO or invasive mechanical ventilation, Score 8: Death].
Note 2) Grade 3 and higher AEs were collected and considered related to study drug. In addition, grade 2 suspected study drug related hypersensitivity reaction AEs were collected.
GS-US-540-5773 Study (NCT04292899): In comparison part of the randomized, open-label, parallel-group study of patients with severe SARS-CoV-2 infection aged 12 to <18 years with body weight at least 40 kg and aged 18 years or older (397 subjects), in the 5-day treatment group, remdesivir was administered intravenously at 200 mg on Day 1 followed by 100 mg on Days 2 to 5, and in the 10-day treatment group, remdesivir was administered intravenously at 200 mg on Day 1 followed by 100 mg on Days 2 to 10. If the subject was discharged from the hospital, the remdesivir treatment was discontinued. Both treatment groups received standard of care therapies. The primary endpoint was clinical status assessed by the 7-point ordinal scale ^{Note 3)} at 13 days after randomization. The proportional odds ratio for clinical status improvement in the 10-day treatment group compared with the 5-day treatment group was 0.75 [95% CI, 0.51 to 1.12]. (See Table 4)

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The key inclusion and exclusion criteria of this study were as shown in the following table. (See Table 5.)

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Adverse reactions in the 5- and 10-day treatment group were reported in 17% (33/200 participants) and 20% (40/197 participants) of subjects, respectively. The most common adverse reactions were ALT increased (5-day group: 2% [4/200 participants], 10-day group: 7% [14/197 participants]), AST increased (5-day group: 3% [5/200 participants], 10-day group: 6% [11/197 participants]), and nausea (5-day group: 5% [9/200 participants], 10-day group: 3% [5/197 participants]).
GS-US-540-5774 Study (NCT04292730): In comparison part of the randomized, open-label, parallel-group study of patients with moderate SARS-CoV-2 infection aged 12 to <18 years with body weight at least 40 kg and aged 18 years or older (584 patients), in the 5-day treatment group, remdesivir was administered intravenously at 200 mg on Day 1 followed by 100 mg on Days 2 to 5, and in the 10-day treatment group, remdesivir was administered intravenously at 200 mg on Day 1 followed by 100 mg on Days 2 to 10, and were compared with standard of care group. If the subject was discharged from the hospital, the study drug was discontinued. Both remdesivir groups received standard of care therapies. The primary endpoint was clinical status assessed by the ordinal scale ^{Note 3)} at 10 days after randomization. Based on proportional odds model, the proportional odds ratio [95% CI] for the 5-day remdesivir treatment group compared with the standard of care group was 1.65 [95% CI, 1.09 to 2.48, p=0.017], in the 10-day remdesivir treatment group compared with the standard of care group was 1.31 [95% CI, 0.88 to 1.95, p=0.18]. (See Table 6.)

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The key inclusion and exclusion criteria in this study were as shown in the following table. (See Table 7.)

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Adverse reactions in the 5-day treatment and 10-day treatment groups were reported in 19% (36/191 patients) and 13% (25/193 patients) of subjects, respectively. The most common adverse reaction was nausea (5-day group: 7% [13/191 participants], 10-day group: 4% [7/193 participants]).
Note 3) 7-point ordinal scale: (1) Death, (2) Hospitalized, on ECMO or invasive mechanical ventilation, (3) Hospitalized, on non-invasive ventilation or high-flow oxygen devices, (4) Hospitalized, requiring low-flow oxygen, (5) Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care (SARS-CoV-2 infection related or otherwise), (6) Hospitalized, not requiring supplemental oxygen - no longer require ongoing medical care (other than per-protocol remdesivir administration), (7) Not hospitalized.
Other Phase III study: GS-US-540-9012 (NCT04292730): A randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted in 562 patients aged 12 to <18 years with body weight at least 40 kg or ≥18 years with SARS-CoV-2 infection and at least one risk factor for progression. They received remdesivir 200 mg IV once daily on Day 1 followed by remdesivir 100 mg IV once daily on Days 2 and 3 or placebo-to-match for 3 days. In addition to study drug, standard of care was allowed in accordance with local guidelines for the treatment of infections with SARS-CoV-2. The primary endpoint was the proportion of patients with SARS-CoV-2 infection related hospitalization or all-cause mortality through Day 28. In results of the primary endpoint, events occurred in 2 (0.7%) patients treated with remdesivir compared to 15 (5.3%) patients concurrently randomized to placebo, demonstrating an 87% reduction in SARS-CoV-2 infection related hospitalization or all-cause mortality through Day 28 compared to placebo (hazard ratio, 0.134; [95% CI 0.031 to 0.586]; p=0.0076). No deaths occurred by Day 28 in either group. (See Table 8.)

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The key inclusion and exclusion criteria of this study were as shown in the following table. (See Table 9.)

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Adverse reactions in the remdesivir treatment group was reported in 12.2% (34/279 subjects). The most common adverse reactions were nausea in 6.5% (18/279 subjects) and chills in 2.2% (6/279 subjects).
Pharmacokinetics: Blood Level: Pharmacokinetics in healthy adult subjects: Remdesivir exhibited a linear pharmacokinetic profile when administered ^Note) to non-Japanese healthy adult subjects in a single intravenous dose in the range of 3 to 225 mg over 2 hours.
The pharmacokinetic parameters of remdesivir and its metabolites (nucleoside analogue [GS-441524] and intermediate metabolite [GS-704277]) following 30-minute IV administration of remdesivir 200 mg on Day 1 followed by 100 mg once daily on Days 2 to 5 or 10 in non-Japanese healthy adult subjects are presented as follows.
Note) Approved dosage and administration is IV infusion of remdesivir 200 mg on Day 1 followed by 100 mg once daily from Day 2. (See Table 10.)

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Distribution: In the in-vitro studies, the rate of binding to human plasma proteins for remdesivir was 88 to 93%. Protein binding of nucleoside analogue (GS-441524) was low (2% bound) in human plasma.
After a single intravenous dose of 150 mg of ¹⁴C-labeled remdesivir in non-Japanese healthy adult subjects ^Note), the blood to plasma ratio of ¹⁴C-labeled radioactivity was approximately 0.68 at 15 minutes from start of infusion, increased over time reaching ratio of 1.0 at 5 hours, indicating differential distribution of remdesivir and its metabolites to plasma or cellular components of blood.
Metabolism: Remdesivir is primarily hydrolyzed by carboxylesterase 1 (CES1) and partially metabolized by cathepsin A (CatA) and CYP3A. The intermediate metabolite (GS-704277) yielded by hydrolysis is primarily metabolized by histidine triad nucleotide-binding protein 1 (HINT1). Phosphoramidate cleavage of the intermediate metabolite followed by phosphorylation forms the active triphosphate (GS-443902). Dephosphorylation results in the formation of nucleoside metabolite (GS-441524) that is not efficiently re-phosphorylated.
Excretion: Following a single intravenous dose of 150 mg of ¹⁴C-labeled remdesivir administered to non-Japanese healthy adult subjects ^Note), the mean total recovery of the dose was >92%, consisting of urinary and fecal excretion rates of approximately 74% and 18% respectively. Most of the dose recovered in urine consisted of the metabolite, i.e., nucleoside analog (GS-441524) (49%), with 10% being remdesivir.
Note) Approved Dosage and administration is IV infusion of remdesivir 200 mg on Day 1 followed by 100 mg once daily from Day 2, to be administered.
Patients with Specific Backgrounds: Pediatric Patients: The pharmacokinetics of remdesivir have not been conducted in pediatric patients.
The approved dosage and administration for pediatric patients was determined using simulations based on physiological pharmacokinetic model. In pediatrics with body weight ≥40 kg, steady state exposures of remdesivir and its nucleoside analogue were predicted to be generally similar to those in adults receiving remdesivir at the dosage approved. In pediatrics with body weight <40 kg, the steady state exposure of remdesivir was predicted to be similar to that in adults at the approved body weight-based dosage, while the exposure of nucleoside analogue in younger children was predicted to tend to be lower than that of adults
Renal Impairment: The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment [see Precautions Concerning Patients with Specific Backgrounds: Patients with Renal Impairment under Precautions].
Hepatic Impairment: The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment [see Precautions Concerning Patients with Specific Backgrounds: Patients with ALT ≥5 times the Upper Limit of Normal Range under Precautions].
Drug-Drug Interactions: In vitro Studies: Remdesivir is a substrate for OATP1B1 and P-gp. And it has inhibitory effect to CYP3A, UGT1A1, OATP1B1, OATP1B3 and MATE1. Intermediate metabolite (GS-704277) is a substrate for OATP1B1 and OATP1B3.
Clinical Drug-Drug Interaction Studies: Drug-drug interaction of remdesivir have not been conducted.

SARS-CoV-2 Infection.

The recommended dosage in adults and pediatrics with body weight ≥40 kg is a single dose of remdesivir 200 mg IV injection on Day 1 followed by once-daily doses of remdesivir 100 mg IV injection from Day 2.
The recommended dosage in pediatrics with body weight between 3.5 kg and <40 kg is a body weight-based dosing regimen of one dose of remdesivir 5 mg/kg IV injection on Day 1 followed by remdesivir 2.5 mg/kg IV injection from Day 2.
Total treatment duration should be up to 10 days.

Patients with a history of hypersensitivity to any of the components of VEKLURY.

Precautions Concerning Indication: Given the majority of VEKLURY use in clinical trials, VEKLURY should be used for the following patients. Also, refer the latest guideline on the treatment target of VEKLURY [See Pharmacology: Clinical Studies for Efficacy and Safety: Global Phase III study and Other Phase III study under Actions].
Patients who do not require oxygen support and are considered to need treatment with VEKLURY because of their risk factors for disease progression of SARS-CoV-2 infection etc.
Patients with pneumonia who are infected with SARS-CoV-2.
Precautions Concerning Dosage and Administration: VEKLURY should be added to saline and infused intravenously over 30 to 120 minutes. [See Important Precautions as follows and Precautions Concerning the Preparation of the drug under Cautions for Usage.]
The treatment course of VEKLURY should be initiated as soon as possible after symptom of SARS CoV-2 infection has developed, VEKLURY is administered until Day 3. As a guide, VEKLURY is administered until Day 5 for patients with pneumonia who are infected with SARS-CoV-2, VEKLURY is administered until Day10 if patients do not obtain improvement.
The pharmacokinetics in pediatric patients are unknown. It should be noted that the approved dosage and administration for pediatrics is determined based on a simulation using a physiologically-based pharmacokinetic model. [See Use in Children as follows and Pharmacology: Pharmacokinetics: Patients with Specific Backgrounds: Pediatric Patients under Actions.]
Important Precautions: Since hepatic impairment may occur, patients should be closely monitored by performing liver function tests, before and periodically after initiating administration of remdesivir [See Patients with ALT ≥5 times the Upper Limit of Normal Range as follows and Clinically Significant Adverse Reactions: Hepatic Impairment under Adverse Reactions].
Since hypersensitivity including infusion reactions and anaphylactic reactions may occur, patient's condition should be carefully monitored, and if any abnormalities are observed, administration of this drug should be discontinued immediately, and appropriate measures should be taken. Slower infusion rates can be considered to potentially prevent these events. [See Precautions Concerning Dosage and Administration as mentioned previously and Hypersensitivity (Including infusion reactions and anaphylactic reactions) under Adverse Reactions]
Patients should be closely monitored by performing renal function tests before and periodically after initiating administration of remdesivir because Sulfobutylether β-cyclodextrin sodium of excipient may cause renal impairment. [See Patients with Renal Impairment as follows]
Other Precautions: Information Based on Clinical Use: In a clinical study (NIAID ACTT-1) of patients with SARS-CoV-2 infection, the incidence of increased prothrombin time or INR was higher in subjects who received VEKLURY compared to placebo. In addition, there was no difference observed in the incidence of bleeding events between the two groups.
Information Based on Nonclinical Studies: In the 7-day intravenous administration study in rhesus monkeys, deaths associated with renal toxicity occurred in the 20 mg/kg/day dose group, and increases in blood urea nitrogen and creatinine, and renal tubular tissue damage were observed in the ≥5 mg/kg/day dose groups. In the 14 or 28-day intravenous administration study in rats, abnormalities of blood renal function markers, increases of urea nitrogen and creatine, urine electrolyte and protein abnormalities, and renal tubular tissue damage were observed at below the clinical exposure level (≥10 mg/kg/day). In the 28-day intravenous administration study in cynomolgus monkeys, no nephrotoxicity was observed at the highest dose (10 mg/kg).
Precautions Concerning Patients with Specific Backgrounds: Patients with Renal Impairment: Since the excipient sulfobutylether-β-cyclodextrin sodium accumulates in the renal tubules, renal impairment may be exacerbated. In nonclinical study, effects on renal tubular have been observed by remdesivir. No clinical studies have been completed in patients with renal impairment [See Important Precautions, Other Precautions: Information Based on Clinical Use as previously mentioned and Pharmacology: Pharmacokinetics: Patients with Specific Backgrounds: Renal Impairment under Actions].
Patients with Severe Renal Impairment (eGFR<30 mL/min/1.73 m² for Adults, Infants, Children and Older Children; Serum Creatinine ≥1 mg/dL for Newborn [7 days to 28 days]): Not recommended to administer. Remdesivir should be considered to only administer if the therapeutic benefits outweigh the risks [See Use in Children as follows and Pharmacology: Clinical Studies: Clinical Studies for Efficacy and Safety: Global Phase III study and Other Phase III study under Actions].
Patients with Hepatic Impairment: Patients with ALT ≥5 times the Upper Limit of Normal Range: Preferable not to administer. Hepatic impairment may be exacerbated. No clinical studies have been completed in patients with hepatic impairment [See Important Precautions as previously mentioned, Clinically Significant adverse reactions under Adverse Reactions: Hepatic Impairment under Adverse Reactions, Pharmacology: Clinical Results: Efficacy and Safety Studies under Actions, and Pharmacology: Pharmacokinetics: Patients with Specific Backgrounds: Hepatic Impairment under Actions].
Use in Children: Remdesivir should be administered only if the therapeutic benefits outweigh the risks. No clinical studies in children have been completed. The excipient sulfobutylether-β-cyclodextrin sodium shows toxicity to the renal tubules and its effect on children aged <2 years (whose kidneys are still developing) is unknown. [See Patients with Renal Impairment as previously mentioned.]
The pharmacokinetics in pediatric patients are unknown. The dosage and administration approved for pediatric patients were determined using simulations based on physiological pharmacokinetic models. [See Precautions Concerning Dosage and Administration as previously mentioned and Pharmacology: Pharmacokinetics: Patients with Specific Backgrounds: Pediatric Patients under Actions.]
Use in Elderly: Remdesivir should be carefully administered while monitoring the patient's condition. In general, elderly patients may have decreased physiological functions, higher frequencies of co-morbid conditions or previous history of diseases.

Pregnant Women: Remdesivir should only be administered to pregnant women or women who may possibly be pregnant if the therapeutic benefits outweigh the risks. In studies of effects on embryo-fetal development in pregnant rats and rabbits, IV administration of remdesivir up to 20 mg/kg (the systemic exposure (AUC) to a major circulating metabolite (nucleoside analogue) corresponding to 4-fold exposure level at the approved dose) did not affect embryo-fetal development. In a study of the effect on fertility and early embryonic development in female rats, a decrease in corpora lutea, embryonic implantations, and viable embryos was observed following intravenously administration of remdesivir 10 mg/kg (the systemic exposure (AUC) of the major circulating metabolite (nucleoside analogue) was correspond to 1.3-fold exposure level at the approved dose).
Breast-feeding Women: Lactation should be continued or discontinued in consideration of therapeutic benefits and benefits of maternal nursing. In animal studies (rat), remdesivir and its metabolites have been detected in the nursing pups of mothers given remdesivir, likely due to the presence of remdesivir into breast milk.

The following adverse reactions may occur. Patients should be carefully monitored and if any abnormalities are observed, appropriate measures such as discontinuing administration of VEKLURY should be taken.
Clinically Significant Adverse Reactions: Hepatic Impairment: If the signs or symptoms of hepatic impairment or laboratory abnormalities (abnormality of conjugated bilirubin, ALP or INR) are observed in addition to ALT elevations, treatment should be discontinued. [See Important Precautions and Patients with Hepatic Impairment under Precautions.]
Hypersensitivity (Including infusion reactions and anaphylactic reactions): Hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering, etc. may occur. [See Important Precautions under Precautions.]
Other adverse reactions: See Table 11.

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Drug-drug interaction studies of remdesivir have not been conducted [See Pharmacology: Pharmacokinetics: Drug-drug Interaction: In vitro Studies and Clinical Drug-Drug Interaction Studies under Actions]. (See Table 12.)

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Precautions Concerning the Preparation of the drug: Only use sterile water for injection to reconstitute VEKLURY IV for infusion.
Add 19 mL of sterile water for injection to the vial, immediately shake the vial for 30 seconds. After allowing to stand for 2 to 3 minutes, it should be confirmed if the solution in the vial is clear (concentration: 5 mg/mL). If the contents of the vial are not completely dissolved, repeat to shake the vial and allow the contents to settle.
Visually confirm if there are no defect on vial closure system and no particulates in the solution. Do not use if any defects or particulates are observed.
After reconstitution with sterile water for Injection, the diluted solution should be used within 4 hours at 20 to 25℃ or within 24 hours at 2 to 8℃.
For adults and pediatrics with body weight ≥40 kg, 2 vials should be used for the administration on Day 1 (remdesivir 200 mg), and 20 mL each from each vial (40 mL in total) should be added to saline to make the total volume 100 mL or 250 mL. For the administration from Day2 (remdesivir 100 mg), 20 mL from 1 vial should be added to saline to make the total volume 100 mL or 250 mL. For pediatrics with body weight between 3.5 kg and <40 kg, dose should be adjusted according to Tables 8 and 9.
To mix, gently invert the infusion bag approximately 20 times, but avoid shaking.
After addition saline, any solution has been stored for >24 hours at 20-25°C or for >48 hours at 2-8°C, including the time after dissolution in water for injection, should be discarded without use. (See Tables 13 and 14.)

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Precautions Concerning Administration of the Drug: The drug should not be administered simultaneously with other drugs. Compatibility with anything other than saline is unknown.
Since VEKLURY does not contain preservatives, any unused reconstituted solution after preparation and any residue reconstituted solution after preparation should be discarded.

Antivirals

J05AB16 - remdesivir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

P₁S₁S₃