Veklury

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veklury 100 mg concentrate for solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 100 mg of remdesivir. 
Each mL of concentrate contains 5 mg of remdesivir. 
 
Excipients with known effect 
 
Each vial contains 6 g betadex sulfobutyl ether sodium 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Concentrate for solution for infusion (sterile concentrate). 
Clear, colorless to yellow, aqueous-based concentrated solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and 
adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring 
supplemental oxygen (see section 5.1). 
 
4.2 Posology and method of administration 
 
Use of remdesivir is confined to healthcare facilities in which patients can be monitored closely (see 
section 4.4). 
 
Posology 
 
The recommended dosage of remdesivir in patients 12 years of age and older and weighing at least 
40 kg is: 
• Day 1 – single loading dose of remdesivir 200 mg given by intravenous infusion 
• Day 2 onwards – 100 mg given once daily by intravenous infusion. 
 
The total duration of treatment should be at least 5 days and not more than 10 days. 
 
Special populations 
 
Elderly 
No dose adjustment of remdesivir is required in patients over the age of 65 years (see sections 5.1 and 
5.2). 
 



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Renal impairment 
The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment. 
Patients with eGFR ≥30 mL/min have received remdesivir for treatment of COVID-19 with no dose 
adjustment. Remdesivir should not be used in patients with eGFR <30 mL/min (see sections 4.4 and 
5.2). 
 
Hepatic impairment 
The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment. It is 
not known if dosage adjustment is appropriate in patients with hepatic impairment (see section 4.4 and 
5.2). 
 
Paediatric population 
The safety and efficacy of remdesivir in children under the age of 12 years and weighing <40 kg have 
not yet been established. No data are available. 
 
Method of administration 
 
For intravenous use. 
 
Remdesivir is for administration by intravenous infusion after further dilution. 
 
It must not be given as an intramuscular (IM) injection. 
 
For instructions on dilution of the medicinal product before administration, see section 6.6. 
 
Table 1: Recommended rate of infusion – for diluted remdesivir concentrate for solution for 

infusion 

Infusion Bag 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 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Hypersensitivity including infusion-related and anaphylactic reactions 
 
Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed 
during and following administration of remdesivir. Signs and symptoms may include hypotension, 
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, 
vomiting, 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. If signs and 
symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue 
administration of remdesivir and initiate appropriate treatment. 
 



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Transaminase elevations 
 
Transaminase elevations have been observed in the remdesivir clinical trials, including in healthy 
volunteers and patients with COVID-19. Liver function should be determined in all patients prior to 
starting remdesivir and should be monitored while receiving it as clinically appropriate. No clinical 
studies with remdesivir have been conducted in patients with hepatic impairment. Remdesivir should 
only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk. 
• Remdesivir should not be initiated in patients with Alanine Aminotransferase (ALT) ≥5 times 

the upper limit of normal at baseline 
• Remdesivir should be discontinued in patients who develop: 

◦ ALT ≥5 times the upper limit of normal during treatment with remdesivir. It may be 
restarted when ALT is <5 times the upper limit of normal. 
OR 

◦ ALT elevation accompanied by signs or symptoms of liver inflammation or increasing 
conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR) (see 
sections 4.8 and 5.2). 

 
Renal impairment 
 
In animal studies on rats and monkeys, severe renal toxicity was observed (see section 5.3). The 
mechanism of this renal toxicity is not fully understood. A relevance for humans cannot be excluded. 
 
All patients should have eGFR determined prior to starting remdesivir and while receiving it as 
clinically appropriate. Remdesivir should not be used in patients with eGFR <30 mL/min. 
 
Excipients 
 
Remdesivir contains betadex sulfobutyl ether sodium, which is renally cleared and accumulates in 
patients with decreased renal function, which may potentially adversely affect renal function. 
Therefore remdesivir should not be used in patients with eGFR <30 mL/min (see section 4.2 and 5.2). 
 
Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine  
 
Coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulphate is not 
recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the 
intracellular metabolic activation and antiviral activity of remdesivir (see section 4.5, 5.1) 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No clinical interaction studies have been performed with remdesivir. The overall potential for 
interactions is currently unknown; patients should remain under close observation during the days of 
remdesivir administration. Due to antagonism observed in vitro, concomitant use of remdesivir with 
chloroquine phosphate or hydroxychloroquine sulphate is not recommended. 
 
Effects of other medicinal products on remdesivir 
 
In vitro, remdesivir is a substrate for esterases in plasma and tissue, drug metabolizing enzymes 
CYP2C8, CYP2D6, and CYP3A4, and is a substrate for Organic Anion Transporting 
Polypeptides 1B1 (OATP1B1) and P-glycoprotein (P-gp) transporters. 
 
The potential of interaction of remdesivir with inhibitors/inducers of the hydrolytic pathway (esterase) 
or CYP2C8, 2D6 or 3A4 has not been studied. The risk of clinically relevant interaction is unknown. 
Strong inhibitors may result in increased remdesivir exposure. The use of strong inducers (e.g. 
rifampicin) may decrease plasma concentrations of remdesivir and is not recommended. 
 
Dexamethasone is reported to be a moderate inducer of CYP3A and P-gp. Induction is dose-dependent 
and occurs after multiple doses. Dexamethasone is unlikely to have a clinically significant effect on 



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remdesivir as remdesivir has a moderate-high hepatic extraction ratio, and is used for a short duration 
in the treatment of COVID-19.  
 
Effects of remdesivir on other medicinal products 
 
In vitro, remdesivir is an inhibitor of CYP3A4, OATP1B1 and OATP1B3. The clinical relevance of 
these in vitro drug interactions has not been established. Remdesivir may transiently increase plasma 
concentrations of medicinal products that are substrates of CYP3A or OATP 1B1/1B3. No data is 
available, however it can be suggested that medicinal products that are substrates of CYP3A4 or 
substrates of OATP 1B1/1B3 should be administered at least 2 hours after remdesivir. Remdesivir 
induced CYP1A2 and potentially CYP3A in vitro. Co-administration of remdesivir with CYP1A2 or 
CYP3A4 substrates with narrow therapeutic index may lead to loss of their efficacy. 
 
Dexamethasone is a substrate of CYP3A4 and although remdesivir inhibits CYP3A4, due to 
remdesivir's rapid clearance after I.V administration, remdesivir is unlikely to have a significant effect 
on dexamethasone exposure. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of remdesivir in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Remdesivir should not be used 
during pregnancy unless the clinical condition of the women requires treatment with it. 
 
Women of child-bearing potential have to use effective contraception during treatment. 
 
Breast-feeding 
 
It is unknown whether remdesivir is excreted in human milk or the effects on the breast-fed infant, or 
the effects on milk production. 
 
In animal studies, the nucleoside analog metabolite GS-441524 has been detected in the blood of 
nursing rat pups of mothers given remedesivir. Therefore, excretion of remdesivir and/or metabolites 
into the milk of lactating animals can be assumed. 
 
Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions 
from the drug in breast-feeding infants, a decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from Remdesivir therapy taking into account the benefit of breast-feeding for 
the child and the benefit of therapy for the woman. 
 
Fertility 
 
No human data on the effect of remdesivir on fertility are available. In male rats, there was no effect 
on mating or fertility with remdesivir treatment. In female rats, however, an impairment of fertility 
was observed (see section 5.3). The relevance for humans is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
Remdesivir is predicted to have no or negligible influence on these abilities. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reaction in healthy volunteers is increased transaminases (14%). The most 
common adverse reaction in patients with COVID-19 is nausea (4%). 



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Tabulated summary of adverse reactions 
 
The adverse reactions in Table 2 are listed below by system organ class and frequency. Frequencies 
are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to 
<1/100); rare (≥1/10,000 to <1/1,000). 
 
Table 2: Tabulated list of adverse reactions 
Frequency Adverse reaction 

Immune system disorders 
Rare hypersensitivity 
Nervous system disorders 
Common headache 
Gastrointestinal disorders 
Common nausea 
Hepatobiliary disorders 
Very common transaminases increased 
Skin and subcutaneous tissue disorders 
Common rash 
Injury, poisoning and procedural complications 
Rare infusion-related reaction 
 
Description of selected adverse reactions 
 
Transaminases Increased 
In healthy volunteer studies, increases in ALT, aspartate aminotransferase (AST) or both in subjects 
who received remdesivir were grade 1 (10%) or grade 2 (4%). In a randomised, double-blind, placebo-
controlled clinical study of patients with COVID-19 (NIAID ACTT-1), the incidence of grade ≥3 non-
serious adverse events of increased aminotransferase levels including ALT, AST, or both was 4% in 
patients receiving remdesivir compared with 6% in receiving placebo. In a randomised, open-label 
multi-centre clinical trial (Study GS-US-540-5773) in hospitalised patients with severe COVID-19 
receiving remdesivir for 5 (n=200) or 10 days (n=197), any grade (≥1.25 × upper limit of normal 
(ULN)) laboratory abnormalities of increased AST and increased ALT occurred in 40% and 42% of 
patients, respectively, receiving remdesivir. Grade ≥3 (≥5.0 × ULN) laboratory abnormalities of 
increased AST and increased ALT both occurred in 7% of patients receiving remdesivir. In a 
randomised, open-label multi-centre clinical trial (Study GS-US-540-5774) in hospitalised patients 
with moderate COVID-19 receiving remdesivir for 5 (n=191) or 10 days (n=193) compared to 
standard of care (n=200), any grade laboratory abnormalities of increased AST and increased ALT 
occurred in 32% and 33% of patients, respectively, receiving remdesivir, and 33% and 39% of patients, 
respectively, receiving standard of care. Grade ≥3 laboratory abnormalities of increased AST and 
increased ALT occurred in 2% and 3% of patients, respectively, receiving remdesivir and 6% and 7%, 
respectively, receiving standard of care. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
Treatment of overdose with remdesivir should consist of general supportive measures including 
monitoring of vital signs and observation of the clinical status of the patient. There is no specific 
antidote for overdose with remdesivir. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, other antivirals, ATC 
code: not yet assigned 
 
Mechanism of action 
 
Remdesivir is an adenosine nucleotide prodrug that is metabolized within host cells to form the 
pharmacologically active nucleoside triphosphate metabolite. Remdesivir triphosphate 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. 
 
Antiviral activity 
 
Remdesivir exhibited in vitro activity against a clinical isolate of SARS-CoV-2 in primary human 
airway epithelial cells with a 50% effective concentration (EC50) of 9.9 nM after 48 hours of treatment. 
The EC50 values of remdesivir against SARS-CoV-2 in Vero cells were 137 nM at 24 hours and 
750 nM at 48 hours post-treatment. The antiviral activity of remdesivir was antagonised by 
chloroquine phosphate in a dose-dependent manner when the two drugs were co-incubated at clinically 
relevant concentrations in HEp-2 cells infected with respiratory syncytial virus (RSV). Higher 
remdesivir EC50 values were observed with increasing concentrations of chloroquine phosphate. 
Increasing concentrations of chloroquine phosphate reduced formation of remdesivir triphosphate in 
normal human bronchial epithelial cells. 
 
Resistance 
 
Cell culture 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 5.6-fold reduced susceptibility to remdesivir. Introduction of the 
corresponding substitutions (F480L and V557L) into SARS-CoV resulted in 6-fold reduced 
susceptibility to remdesivir cell culture and attenuated SARS-CoV pathogenesis in a mouse model. 
 
The cell culture development of SARS-CoV-2 resistance to remdesivir has not been assessed to date. 
No clinical data are available on the development of SARS-CoV-2 resistance to remdesivir. 
 
Clinical efficacy and safety 
 
Clinical trials in patients with COVID-19 
 
NIAID ACTT-1 Study (CO-US-540-5776) 
A randomised, double-blind, placebo-controlled clinical trial evaluated remdesivir 200 mg once daily 
for 1 day followed by remdesivir 100 mg once daily for up to 9 days (for a total of up to 10 days of 
intravenously administered therapy) in hospitalised adult patients with COVID-19 with evidence of 
lower respiratory tract involvement. The trial enrolled 1,063 hospitalised patients: 120 (11.3%) 
patients with mild/moderate disease (defined by SpO2 >94% and respiratory rate <24 breaths/min 
without supplemental oxygen) and 943 (88.7%) patients with severe disease (defined by SpO2 ≤94% 
on room air, or respiratory rate ≥24 breaths/min and requiring supplemental oxygen or ventilatory 



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support). Patients were randomised 1:1, stratified by disease severity at enrolment, to receive 
remdesivir (n=541) or placebo (n=522), plus standard of care. 
 
The baseline mean age was 59 years and 36% of patients were aged 65 or older. Sixty-four percent 
were male, 53% were White, 21% were Black, 13% were Asian. The most common comorbidities 
were hypertension (49.6%), obesity (37.0%), type 2 diabetes mellitus (29.7%), and coronary artery 
disease (11.6%). 
 
Approximately 33% (180/541) of the patients received a 10-day treatment course with remdesivir. 
 
The primary clinical endpoint was time to recovery within 28 days after randomisation, defined as 
either discharged from hospital (with or without limitations of activity and with or without home 
oxygen requirements) or hospitalised but not requiring supplemental oxygen and no longer requiring 
ongoing medical care. In an analysis performed after all patients had been followed up for 14 days, the 
median time to recovery in the overall population was 11 days in the remdesivir group compared to 
15 days in the placebo group (recovery rate ratio 1.32; [95% CI 1.12 to 1.55], p<0.001). The outcome 
differed relevantly between the two strata. In the severe disease stratum time to recovery was 12 days 
in the remdesivir group and 18 days in the placebo group (recovery rate ratio 1.37 [95% CI: 1.15 to 
1.63]; Table 3). For the mild/moderate disease stratum, time to recovery was not different between the 
two groups (5 days for both, remdesivir and placebo). 
 
Table 3: Recovery outcomes in the severe disease stratum from NIAID ACTT-1 
 Remdesivir (N=476) Placebo (N=464) 

Days to recovery 
Number of recoveries 282 227 

Median (95 %CI) 12 (10; 14) 18 (15; 21) 
Recovery rate ratio (95% CI)a 1.37 (1.15; 1.63) 

a Recovery rate ratio calculated from the stratified Cox model. Recovery rate ratios >1 indicate 
benefit for remdesivir 

 
There was no difference in efficacy in patients randomized during the first 10 days after onset of 
symptoms as compared to those with symptoms for more than 10 days. 
The clinical benefit of remdesivir was most apparent in patients receiving oxygen, however, not on 
ventilation, at Day 1 (rate recovery ratio 1.47 [95% CI 1.17–1.84]). For patients who were receiving 
mechanical ventilation or ECMO on Day 1 no difference in recovery rate was observed between the 
treatment groups (0.95 [95% CI 0.64 to 1.42]). 
 
QT 
Current non-clinical and clinical data do not suggest a risk of QT prolongation, but QT prolongation 
has not been fully evaluated in humans. 
 
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This 
means that further evidence on this medicinal product is awaited. The European Medicines Agency 
will review new information on this medicinal product at least every year and this SmPC will be 
updated as necessary. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
remdesivir in one or more subsets of the paediatric population (see section 4.2 and 5.2 for information 
on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of remdesivir has been investigated in healthy volunteers. No 
pharmacokinetic data is available from patients with COVID-19. 



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Absorption 
 
The pharmacokinetic properties of remdesivir and the predominant circulating metabolite GS-441524 
have been evaluated in healthy adult subjects. Following intravenous administration of remdesivir 
adult dosage regimen, peak plasma concentration was observed at end of infusion, regardless of dose 
level, and declined rapidly thereafter with a half-life of approximately 1 hour. Peak plasma 
concentrations of GS-441524 were observed at 1.5 to 2.0 hours post start of a 30 minutes infusion. 
 
Distribution 
 
Remdesivir is approximately 88% bound to human plasma proteins. Protein binding of GS-441524 
was low (2% bound) in human plasma. After a single 150 mg dose of [14C]-remdesivir in healthy 
subjects, the blood to plasma ratio of 14C-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. 
 
Biotransformation 
 
Remdesivir is extensively metabolized to the pharmacologically active nucleoside analog triphosphate 
GS-443902 (formed intracellularly). The metabolic activation pathway involves hydrolysis by 
esterases, which leads to the formation of the intermediate metabolite, GS-704277. Phosphoramidate 
cleavage followed by phosphorylation forms the active triphosphate, GS-443902. Dephosphorylation 
of all phosphorylated metabolites can result in the formation of nucleoside metabolite GS-441524 that 
itself is not efficiently re-phosphorylated. The human mass balance study also indicates presence of a 
currently unidentified major metabolite (M27) in plasma. 
 
Elimination 
 
Following a single 150 mg IV dose of [14C]-remdesivir, mean total recovery of the dose was 92%, 
consisting of approximately 74% and 18% recovered in urine and feces, respectively. The majority of 
the remdesivir dose recovered in urine was GS-441524 (49%), while 10% was recovered as remdesivir. 
These data indicate that renal clearance is the major elimination pathway for GS-441524. The median 
terminal half-lives of remdesivir and GS-441524 were approximately 1 and 27 hours, respectively. 
 
Other special populations 
 
Gender, race and age 
Pharmacokinetic differences for gender, race, and age have not been evaluated. 
 
Paediatric patients 
The pharmacokinetics in paediatric patients have not been evaluated. 
 
Renal impairment 
The pharmacokinetics of remdesivir and GS-441524 in renal impairment has not been evaluated. 
Remdesivir is not cleared unchanged in urine to any substantial extent, but its main metabolite 
GS-441524 is renally cleared and the metabolite levels in plasma may theoretically increase in patients 
with impaired renal function. The excipient betadex sulfobutyl ether sodium is renally cleared and 
accumulates in patients with decreased renal function. Veklury should not be used in patients with 
eGFR <30 mL/min. 
 
Hepatic impairment 
The pharmacokinetics of remdesivir and GS-441524 in hepatic impairment has not been evaluated. 
The role of the liver in the metabolism of remdesivir is unknown. 
 



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Interactions 
The potential of interaction of remdesivir as a victim was not studied with regards to the inhibition of 
the hydrolytic pathway (esterase). The risk of clinically relevant interaction is unknown. 
 
Remdesivir inhibited CYP3A4 in vitro (see section 4.5). At physiologically relevant concentrations 
(steady-state), remdesivir or its metabolites GS-441524 and GS-704277 did not inhibit CYP1A2, 2B6, 
2C8, 2C9, 2C19, and 2D6 in vitro. Remdesivir may however transiently inhibit CYP2B6, 2C8, 2C9 
and 2D6 on the first day of administration. The clinical relevance of this inhibition was not studied. 
The potential for time-dependent inhibition of CYP450 enzymes by remdesivir was not studied. 
 
Remdesivir induced CYP1A2 and potentially CYP3A4, but not CYP2B6 in vitro (see section 4.5). 
 
In vitro data indicates no clinically relevant inhibition of UGT1A1, 1A3, 1A4, 1A6, 1A9 or 2B7 by 
remdesivir or its metabolites GS-441524 and GS-704277. 
 
Remdesivir inhibited OATP1B1 and OATP1B3 in vitro (see section 4.5). No data is available for 
OAT1, OAT3 or OCT2 inhibition by remdesivir. 
 
At physiologically relevant concentrations, remdesivir and its metabolites did not inhibit PgP and 
BCRP in vitro. 
 
5.3 Preclinical safety data 
 
Toxicology 
Following intravenous administration (slow bolus) of remdesivir to rhesus monkeys and rats, severe 
renal toxicity occurred after short treatment durations. In 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, and an unscheduled death 
of one animal at the 20 mg/kg/day dose level. In rats, dosage levels of >3 mg/kg/day for up to 4 weeks 
resulted in findings indicative of kidney injury and/or dysfunction. Systemic exposures (AUC) of the 
predominant circulating metabolite of remdesivir (GS-441524) were 0.1 times (monkeys at 
5 mg/kg/day) and 0.3 times (rat at 3 mg/kg/day) the exposure in humans at the RHD. An unidentified 
major metabolite (M27) was shown to be present in human plasma (see section 5.2). The exposure of 
M27 in rhesus monkeys and rats is unknown. Animal studies may therefore not be informative of 
potential risks associated with this metabolite. 
 
Carcinogenesis 
Long-term animal studies to evaluate the carcinogenic potential of remdesivir have not been performed. 
 
Mutagenesis 
Remdesivir was not genotoxic in a battery of assays, including bacterial mutagenicity, chromosome 
aberration using human peripheral blood lymphocytes, and in vivo rat micronucleus assays. 
 
Reproductive toxicity 
In female rats, decreases in corpora lutea, numbers of implantation sites, and viable embryos, were 
seen when remdesivir was administered intravenously daily at a systemically toxic dose (10 mg/kg/day) 
14 days prior to mating and during conception; exposures of the predominant circulating metabolite 
(GS-441524) were 1.3 times the exposure in humans at the RHD. There were no effects on female 
reproductive performance (mating, fertility, and conception) at this dose level. 
 
In rats and rabbits, remdesivir demonstrated no adverse effect on embryofoetal development when 
administered to pregnant animals at systemic exposures (AUC) of the predominant circulating 
metabolite of remdesivir (GS-441524) that were up to 4 times the exposure in humans at the 
recommended human dose (RHD). 
 



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In rats, there were no adverse effects on pre- and post-natal development at systemic exposures (AUC) 
of the predominant circulating metabolite of remdesivir (GS-441524) that were similar to the exposure 
in humans at the recommended human dose (RHD). 
 
It is unknown if the active nucleoside analog triphosphate GS-443902 and the unidentified major 
human metabolite M27 are formed in rats and rabbits. The reproductive toxicity studies may therefore 
not be informative of potential risks associated with these metabolites. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Betadex Sulfobutyl Ether Sodium 
Hydrochloric acid (to adjust pH) 
Sodium hydroxide (to adjust pH) 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed or administered simultaneously with other medicinal 
products in the same dedicated line except those mentioned in section 6.6. 
 
6.3 Shelf life 
 
Unopened vials 
1 year 
 
Diluted solution for infusion 
Store diluted remdesivir solution for infusion up to 4 hours below 25°C or 24 hours in a refrigerator or 
(2°C – 8°C). 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
 
For storage conditions after dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Type I clear glass vial, an elastomeric closure, and an aluminium overseal with a flip-off cap. 
 
Pack size: 1 vial 
 
6.6 Special precautions for disposal and other handling 
 
Prepare solution for infusion under aseptic conditions and on the same day as administration. 
Remdesivir should be inspected visually for particulate matter and discoloration prior to administration, 
whenever solution and container permit. Should either be observed, the solution should be discarded 
and fresh solution prepared. 
 
Remdesivir must be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection before being 
administered via intravenous infusion over 30 to 120 minutes. 
 



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Preparation of remdesivir solution for infusion 
 
Dilution 
Care should be taken 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 IV medicines immediately after 
preparation when possible. 
 
Remove the required number of single-use vial(s) from storage. For each vial: 
• Allow to warm to room temperature (20°C to 25°C). 
• Inspect the vial to ensure the container closure is free from defects and the concentrate for 

solution for infusion is free of particulate matter. 
• Using Table 4, determine the volume of sodium chloride 9 mg/mL (0.9%) to withdraw from the 

infusion bag. 
 
Table 4: Recommended dilution instructions – remdesivir concentrate for solution for 

infusion 

Remdesivir 
dose 

Sodium chloride 
9 mg/mL (0.9%) 

infusion bag volume to 
be used 

Volume to be withdrawn 
and discarded from sodium 
chloride 9 mg/mL (0.9%) 

infusion bag 
Required volume of 

remdesivir 
200 mg 
(2 vials) 250 mL 

40 mL 2 × 20 mL 

100 mg 
(1 vial) 20 mL 20 mL 

 
• Withdraw and discard the required volume of sodium chloride 9 mg/ml from the bag per Table 4 

using an appropriately sized syringe and needle. 
• Withdraw the required volume of remdesivir concentrate for solution for infusion from the 

remdesivir vial using an appropriately sized syringe per Table 4. 
◦ Pull the syringe plunger rod back to fill the syringe with approximately 10 mL of air. 
◦ Inject the air into the remdesivir injection vial above the level of the solution. 
◦ Invert the vial and withdraw the required volume of remdesivir concentrate for solution 

for infusion into the syringe. The last 5 mL of solution requires more force to withdraw. 
• Discard any unused solution remaining in the remdesivir vial. 
• Transfer the required volume of remdesivir concentrate for solution for infusion to the infusion 

bag. 
• Gently invert the bag 20 times to mix the solution in the bag. Do not shake. 
• The prepared diluted infusion solution is stable for 4 hours at room temperature (20°C to 25°C) 

or 24 hours in the refrigerator at 2°C to 8°C. 
 
After infusion is complete, flush with at least 30 mL of sodium chloride 9 mg/ml. 
 
Disposal 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 
 
 



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8. MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1459/001 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY} 

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


14 

 
This medicinal product is subject to additional monitoring. This will allow quick identification of 

new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veklury 100 mg powder for concentrate for solution for infusion 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 100 mg of remdesivir. After reconstitution, each vial contains 5 mg/mL of 
remdesivir solution. 
 
Excipients with known effect 
 
Each vial contains 3 g betadex sulfobutyl ether sodium 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for concentrate for solution for infusion (powder for concentrate). 
White to off-white to yellow powder. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and 
adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring 
supplemental oxygen (see section 5.1). 
 
4.2 Posology and method of administration 
 
Use of remdesivir is confined to healthcare facilities in which patients can be monitored closely (see 
section 4.4). 
 
Posology 
 
The recommended dosage of remdesivir in patients 12 years of age and older and weighing at least 
40 kg is: 
• Day 1 – single loading dose of remdesivir 200 mg given by intravenous infusion 
• Day 2 onwards – 100 mg given once daily by intravenous infusion. 
 
The total duration of treatment should be at least 5 days and not more than 10 days. 
 
Special populations 
 
Elderly 
No dose adjustment of remdesivir is required in patients over the age of 65 years (see sections 5.1 and 
5.2). 
 



15 

Renal impairment 
The pharmacokinetics of remdesivir have not been evaluated in patients with renal impairment. 
Patients with eGFR ≥30 mL/min have received remdesivir for treatment of COVID-19 with no dose 
adjustment. Remdesivir should not be used in patients with eGFR <30 mL/min (see sections 4.4 and 
5.2). 
 
Hepatic impairment 
The pharmacokinetics of remdesivir have not been evaluated in patients with hepatic impairment. It is 
not known if dosage adjustment is appropriate in patients with hepatic impairment (see section 4.4 and 
5.2). 
 
Paediatric population 
The safety and efficacy of remdesivir in children under the age of 12 years and weighing <40 kg have 
not yet been established. No data are available. 
 
Method of administration 
 
For intravenous use. 
 
Remdesivir is for administration by intravenous infusion after reconstitution and further dilution. 
 
It must not be given as an intramuscular (IM) injection. 
 
For instructions on reconstitution and dilution of the medicinal product before administration, see 
section 6.6. 
 
Table 1: Recommended rate of infusion – for reconstituted and diluted remdesivir powder 

for concentrate for solution for infusion 

Infusion Bag 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 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Hypersensitivity including infusion-related and anaphylactic reactions 
 
Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed 
during and following administration of remdesivir. Signs and symptoms may include hypotension, 
hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, 
vomiting, 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. If signs and 
symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue 
administration of remdesivir and initiate appropriate treatment. 
 



16 

Transaminase elevations 
 
Transaminase elevations have been observed in the remdesivir clinical trials, including in healthy 
volunteers and patients with COVID-19. Liver function should be determined in all patients prior to 
starting remdesivir and should be monitored while receiving it as clinically appropriate. No clinical 
studies with remdesivir have been conducted in patients with hepatic impairment. Remdesivir should 
only be used in patients with hepatic impairment if the potential benefit outweighs the potential risk. 
• Remdesivir should not be initiated in patients with Alanine Aminotransferase (ALT) ≥5 times 

the upper limit of normal at baseline 
• Remdesivir should be discontinued in patients who develop: 

◦ ALT ≥5 times the upper limit of normal during treatment with remdesivir. It may be 
restarted when ALT is <5 times the upper limit of normal. 
OR 

◦ ALT elevation accompanied by signs or symptoms of liver inflammation or increasing 
conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR) (see 
sections 4.8 and 5.2). 

 
Renal impairment 
 
In animal studies on rats and monkeys, severe renal toxicity was observed (see section 5.3). The 
mechanism of this renal toxicity is not fully understood. A relevance for humans cannot be excluded. 
 
All patients should have eGFR determined prior to starting remdesivir and while receiving it as 
clinically appropriate. Remdesivir should not be used in patients with eGFR <30 mL/min. 
 
Excipients 
 
Remdesivir contains betadex sulfobutyl ether sodium, which is renally cleared and accumulates in 
patients with decreased renal function, which may potentially adversely affect renal function. 
Therefore remdesivir should not be used in patients with eGFR <30 mL/min (see section 4.2 and 5.2). 
 
Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine  
 
Coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulphate is not 
recommended based on in vitro data demonstrating an antagonistic effect of chloroquine on the 
intracellular metabolic activation and antiviral activity of remdesivir (see section 4.5, 5.1) 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No clinical interaction studies have been performed with remdesivir. The overall potential for 
interactions is currently unknown; patients should remain under close observation during the days of 
remdesivir administration. Due to antagonism observed in vitro, concomitant use of remdesivir with 
chloroquine phosphate or hydroxychloroquine sulphate is not recommended. 
 
Effects of other medicinal products on remdesivir 
 
In vitro, remdesivir is a substrate for esterases in plasma and tissue, drug metabolizing enzymes 
CYP2C8, CYP2D6, and CYP3A4, and is a substrate for Organic Anion Transporting 
Polypeptides 1B1 (OATP1B1) and P-glycoprotein (P-gp) transporters. 
 
The potential of interaction of remdesivir with inhibitors/inducers of the hydrolytic pathway (esterase) 
or CYP2C8, 2D6 or 3A4 has not been studied. The risk of clinically relevant interaction is unknown. 
Strong inhibitors may result in increased remdesivir exposure. The use of strong inducers (e.g. 
rifampicin) may decrease plasma concentrations of remdesivir and is not recommended. 
 
Dexamethasone is reported to be a moderate inducer of CYP3A and P-gp. Induction is dose-dependent 
and occurs after multiple doses. Dexamethasone is unlikely to have a clinically significant effect on 



17 

remdesivir as remdesivir has a moderate-high hepatic extraction ratio, and is used for a short duration 
in the treatment of COVID-19.  
 
Effects of remdesivir on other medicinal products 
 
In vitro, remdesivir is an inhibitor of CYP3A4, OATP1B1 and OATP1B3. The clinical relevance of 
these in vitro drug interactions has not been established. Remdesivir may transiently increase plasma 
concentrations of medicinal products that are substrates of CYP3A or OATP 1B1/1B3. No data is 
available, however it can be suggested that medicinal products that are substrates of CYP3A4 or 
substrates of OATP 1B1/1B3 should be administered at least 2 hours after remdesivir. Remdesivir 
induced CYP1A2 and potentially CYP3A in vitro. Co-administration of remdesivir with CYP1A2 or 
CYP3A4 substrates with narrow therapeutic index may lead to loss of their efficacy. 
 
Dexamethasone is a substrate of CYP3A4 and although remdesivir inhibits CYP3A4, due to 
remdesivir's rapid clearance after I.V administration, remdesivir is unlikely to have a significant effect 
on dexamethasone exposure. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no or limited amount of data from the use of remdesivir in pregnant women. Animal studies 
are insufficient with respect to reproductive toxicity (see section 5.3). Remdesivir should not be used 
during pregnancy unless the clinical condition of the women requires treatment with it. 
 
Women of child-bearing potential have to use effective contraception during treatment. 
 
Breast-feeding 
 
It is unknown whether remdesivir is excreted in human milk or the effects on the breast-fed infant, or 
the effects on milk production. 
 
In animal studies, the nucleoside analog metabolite GS-441524 has been detected in the blood of 
nursing rat pups of mothers given remedesivir. Therefore, excretion of remdesivir and/or metabolites 
into the milk of lactating animals can be assumed. 
 
Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions 
from the drug in breast-feeding infants, a decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from remdesivir therapy taking into account the benefit of breast-feeding for 
the child and the benefit of therapy for the woman. 
 
Fertility 
 
No human data on the effect of remdesivir on fertility are available. In male rats, there was no effect 
on mating or fertility with remdesivir treatment. In female rats, however, an impairment of fertility 
was observed (see section 5.3). The relevance for humans is unknown. 
 
4.7 Effects on ability to drive and use machines 
 
Remdesivir is predicted to have no or negligible influence on these abilities. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most common adverse reaction in healthy volunteers is increased transaminases (14%). The most 
common adverse reaction in patients with COVID-19 is nausea (4%). 



18 

 
Tabulated summary of adverse reactions 
 
The adverse reactions in Table 2 are listed below by system organ class and frequency. Frequencies 
are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to 
<1/100); rare (≥1/10,000 to <1/1,000). 
 
Table 2: Tabulated list of adverse reactions 
Frequency Adverse reaction 

Immune system disorders 
Rare hypersensitivity 
Nervous system disorders 
Common headache 
Gastrointestinal disorders 
Common nausea 
Hepatobiliary disorders 
Very common transaminases increased 
Skin and subcutaneous tissue disorders 
Common rash 
Injury, poisoning and procedural complications 
Rare infusion-related reaction 
 
Description of selected adverse reactions 
 
Transaminases Increased 
In healthy volunteer studies, increases in ALT, aspartate aminotransferase (AST) or both in subjects 
who received remdesivir were grade 1 (10%) or grade 2 (4%). In a randomised, double-blind, placebo-
controlled clinical study of patients with COVID-19 (NIAID ACTT-1), the incidence of grade ≥3 non-
serious adverse events of increased aminotransferase levels including ALT, AST, or both was 4% in 
patients receiving remdesivir compared with 6% in receiving placebo. In a randomised, open-label 
multi-centre clinical trial (Study GS-US-540-5773) in hospitalised patients with severe COVID-19 
receiving remdesivir for 5 (n=200) or 10 days (n=197), any grade (≥1.25 × upper limit of normal 
(ULN)) laboratory abnormalities of increased AST and increased ALT occurred in 40% and 42% of 
patients, respectively, receiving remdesivir. Grade ≥3 (≥5.0 × ULN) laboratory abnormalities of 
increased AST and increased ALT both occurred in 7% of patients receiving remdesivir. In a 
randomised, open-label multi-centre clinical trial (Study GS-US-540-5774) in hospitalised patients 
with moderate COVID-19 receiving remdesivir for 5 (n=191) or 10 days (n=193) compared to 
standard of care (n=200), any grade laboratory abnormalities of increased AST and increased ALT 
occurred in 32% and 33% of patients, respectively, receiving remdesivir, and 33% and 39% of patients, 
respectively, receiving standard of care. Grade ≥3 laboratory abnormalities of increased AST and 
increased ALT occurred in 2% and 3% of patients, respectively, receiving remdesivir and 6% and 7%, 
respectively, receiving standard of care. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


19 

4.9 Overdose 
 
Treatment of overdose with remdesivir should consist of general supportive measures including 
monitoring of vital signs and observation of the clinical status of the patient. There is no specific 
antidote for overdose with remdesivir. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, other antivirals, ATC 
code: not yet assigned 
 
Mechanism of action 
 
Remdesivir is an adenosine nucleotide prodrug that is metabolized within host cells to form the 
pharmacologically active nucleoside triphosphate metabolite. Remdesivir triphosphate 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. 
 
Antiviral activity 
 
Remdesivir exhibited in vitro activity against a clinical isolate of SARS-CoV-2 in primary human 
airway epithelial cells with a 50% effective concentration (EC50) of 9.9 nM after 48 hours of treatment. 
The EC50 values of remdesivir against SARS-CoV-2 in Vero cells were 137 nM at 24 hours and 
750 nM at 48 hours post-treatment. The antiviral activity of remdesivir was antagonised by 
chloroquine phosphate in a dose-dependent manner when the two drugs were co-incubated at clinically 
relevant concentrations in HEp-2 cells infected with respiratory syncytial virus (RSV). Higher 
remdesivir EC50 values were observed with increasing concentrations of chloroquine phosphate. 
Increasing concentrations of chloroquine phosphate reduced formation of remdesivir triphosphate in 
normal human bronchial epithelial cells. 
 
Resistance 
 
Cell culture 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 5.6-fold reduced susceptibility to remdesivir. Introduction of the 
corresponding substitutions (F480L and V557L) into SARS-CoV resulted in 6-fold reduced 
susceptibility to remdesivir cell culture and attenuated SARS-CoV pathogenesis in a mouse model. 
 
The cell culture development of SARS-CoV-2 resistance to remdesivir has not been assessed to date. 
No clinical data are available on the development of SARS-CoV-2 resistance to remdesivir. 
 
Clinical efficacy and safety 
 
Clinical trials in patients with COVID-19 
 
NIAID ACTT-1 Study (CO-US-540-5776) 
A randomised, double-blind, placebo-controlled clinical trial evaluated remdesivir 200 mg once daily 
for 1 day followed by remdesivir 100 mg once daily for up to 9 days (for a total of up to 10 days of 
intravenously administered therapy) in hospitalised adult patients with COVID-19 with evidence of 
lower respiratory tract involvement. The trial enrolled 1,063 hospitalised patients: 120 (11.3%) 
patients with mild/moderate disease (defined by SpO2 >94% and respiratory rate <24 breaths/min 
without supplemental oxygen) and 943 (88.7%) patients with severe disease (defined by SpO2 ≤94% 
on room air, or respiratory rate ≥24 breaths/min and requiring supplemental oxygen or ventilatory 



20 

support). Patients were randomised 1:1, stratified by disease severity at enrolment, to receive 
remdesivir (n=541) or placebo (n=522), plus standard of care. 
 
The baseline mean age was 59 years and 36% of patients were aged 65 or older. Sixty-four percent 
were male, 53% were White, 21% were Black, 13% were Asian. The most common comorbidities 
were hypertension (49.6%), obesity (37.0%), type 2 diabetes mellitus (29.7%), and coronary artery 
disease (11.6%). 
 
Approximately 33% (180/541) of the patients received a 10-day treatment course with remdesivir. 
 
The primary clinical endpoint was time to recovery within 28 days after randomisation, defined as 
either discharged from hospital (with or without limitations of activity and with or without home 
oxygen requirements) or hospitalised but not requiring supplemental oxygen and no longer requiring 
ongoing medical care. In an analysis performed after all patients had been followed up for 14 days, the 
median time to recovery in the overall population was 11 days in the remdesivir group compared to 
15 days in the placebo group (recovery rate ratio 1.32; [95% CI 1.12 to 1.55], p<0.001). The outcome 
differed relevantly between the two strata. In the severe disease stratum time to recovery was 12 days 
in the remdesivir group and 18 days in the placebo group (recovery rate ratio 1.37 [95% CI: 1.15 to 
1.63]; Table 3). For the mild/moderate disease stratum, time to recovery was not different between the 
two groups (5 days for both, remdesivir and placebo). 
 
Table 3: Recovery outcomes in the severe disease stratum from NIAID ACTT-1 
 Remdesivir (N=476) Placebo (N=464) 

Days to recovery 
Number of recoveries 282 227 

Median (95 %CI) 12 (10; 14) 18 (15; 21) 
Recovery rate ratio (95% CI)a 1.37 (1.15; 1.63) 

a Recovery rate ratio calculated from the stratified Cox model. Recovery rate ratios >1 indicate 
benefit for remdesivir 

 
There was no difference in efficacy in patients randomized during the first 10 days after onset of 
symptoms as compared to those with symptoms for more than 10 days. 
The clinical benefit of remdesivir was most apparent in patients receiving oxygen, however, not on 
ventilation, at Day 1 (rate recovery ratio 1.47 [95% CI 1.17–1.84]). For patients who were receiving 
mechanical ventilation or ECMO on Day 1 no difference in recovery rate was observed between the 
treatment groups (0.95 [95% CI 0.64 to 1.42]). 
 
QT 
Current non-clinical and clinical data do not suggest a risk of QT prolongation, but QT prolongation 
has not been fully evaluated in humans. 
 
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This 
means that further evidence on this medicinal product is awaited. The European Medicines Agency 
will review new information on this medicinal product at least every year and this SmPC will be 
updated as necessary. 
 
Paediatric population 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
remdesivir in one or more subsets of the paediatric population (see section 4.2 and 5.2 for information 
on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic properties of remdesivir has been investigated in healthy volunteers. No 
pharmacokinetic data is available from patients with COVID-19. 



21 

 
Absorption 
 
The pharmacokinetic properties of remdesivir and the predominant circulating metabolite GS-441524 
have been evaluated in healthy adult subjects. Following intravenous administration of remdesivir 
adult dosage regimen, peak plasma concentration was observed at end of infusion, regardless of dose 
level, and declined rapidly thereafter with a half-life of approximately 1 hour. Peak plasma 
concentrations of GS-441524 were observed at 1.5 to 2.0 hours post start of a 30 minutes infusion. 
 
Distribution 
 
Remdesivir is approximately 88% bound to human plasma proteins. Protein binding of GS-441524 
was low (2% bound) in human plasma. After a single 150 mg dose of [14C]-remdesivir in healthy 
subjects, the blood to plasma ratio of 14C-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. 
 
Biotransformation 
 
Remdesivir is extensively metabolized to the pharmacologically active nucleoside analog triphosphate 
GS-443902 (formed intracellularly). The metabolic activation pathway involves hydrolysis by 
esterases, which leads to the formation of the intermediate metabolite, GS-704277. Phosphoramidate 
cleavage followed by phosphorylation forms the active triphosphate, GS-443902. Dephosphorylation 
of all phosphorylated metabolites can result in the formation of nucleoside metabolite GS-441524 that 
itself is not efficiently re-phosphorylated. The human mass balance study also indicates presence of a 
currently unidentified major metabolite (M27) in plasma. 
 
Elimination 
 
Following a single 150 mg IV dose of [14C]-remdesivir, mean total recovery of the dose was 92%, 
consisting of approximately 74% and 18% recovered in urine and feces, respectively. The majority of 
the remdesivir dose recovered in urine was GS-441524 (49%), while 10% was recovered as remdesivir. 
These data indicate that renal clearance is the major elimination pathway for GS-441524. The median 
terminal half-lives of remdesivir and GS-441524 were approximately 1 and 27 hours, respectively. 
 
Other special populations 
 
Gender, race and age 
Pharmacokinetic differences for gender, race, and age have not been evaluated. 
 
Paediatric patients 
The pharmacokinetics in paediatric patients have not been evaluated. 
 
Renal impairment 
The pharmacokinetics of remdesivir and GS-441524 in renal impairment has not been evaluated. 
Remdesivir is not cleared unchanged in urine to any substantial extent, but its main metabolite 
GS-441524 is renally cleared and the metabolite levels in plasma may theoretically increase in patients 
with impaired renal function. The excipient betadex sulfobutyl ether sodium is renally cleared and 
accumulates in patients with decreased renal function. Veklury should not be used in patients with 
eGFR <30 mL/min. 
 
Hepatic impairment 
The pharmacokinetics of remdesivir and GS-441524 in hepatic impairment has not been evaluated. 
The role of the liver in the metabolism of remdesivir is unknown. 
 



22 

Interactions 
The potential of interaction of remdesivir as a victim was not studied with regards to the inhibition of 
the hydrolytic pathway (esterase). The risk of clinically relevant interaction is unknown. 
 
Remdesivir inhibited CYP3A4 in vitro (see section 4.5). At physiologically relevant concentrations 
(steady-state), remdesivir or its metabolites GS-441524 and GS-704277 did not inhibit CYP1A2, 2B6, 
2C8, 2C9, 2C19, and 2D6 in vitro. Remdesivir may however transiently inhibit CYP2B6, 2C8, 2C9 
and 2D6 on the first day of administration. The clinical relevance of this inhibition was not studied. 
The potential for time-dependent inhibition of CYP450 enzymes by remdesivir was not studied. 
 
Remdesivir induced CYP1A2 and potentially CYP3A4, but not CYP2B6 in vitro (see section 4.5). 
 
In vitro data indicates no clinically relevant inhibition of UGT1A1, 1A3, 1A4, 1A6, 1A9 or 2B7 by 
remdesivir or its metabolites GS-441524 and GS-704277. 
 
Remdesivir inhibited OATP1B1 and OATP1B3 in vitro (see section 4.5). No data is available for 
OAT1, OAT3 or OCT2 inhibition by remdesivir. 
 
At physiologically relevant concentrations, remdesivir and its metabolites did not inhibit PgP and 
BCRP in vitro. 
 
5.3 Preclinical safety data 
 
Toxicology 
Following intravenous administration (slow bolus) of remdesivir to rhesus monkeys and rats, severe 
renal toxicity occurred after short treatment durations. In 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, and an unscheduled death 
of one animal at the 20 mg/kg/day dose level.In rats, dosage levels of >3 mg/kg/day for up to 4 weeks 
resulted in findings indicative of kidney injury and/or dysfunction. Systemic exposures (AUC) of the 
predominant circulating metabolite of remdesivir (GS-441524) were 0.1 times (monkeys at 
5 mg/kg/day) and 0.3 times (rat at 3 mg/kg/day) the exposure in humans at the RHD. An unidentified 
major metabolite (M27) was shown to be present in human plasma (see section 5.2). The exposure of 
M27 in rhesus monkeys and rats is unknown. Animal studies may therefore not be informative of 
potential risks associated with this metabolite. 
 
Carcinogenesis 
Long-term animal studies to evaluate the carcinogenic potential of remdesivir have not been performed. 
 
Mutagenesis 
Remdesivir was not genotoxic in a battery of assays, including bacterial mutagenicity, chromosome 
aberration using human peripheral blood lymphocytes, and in vivo rat micronucleus assays. 
 
Reproductive toxicity 
In female rats, decreases in corpora lutea, numbers of implantation sites, and viable embryos, were 
seen when remdesivir was administered intravenously daily at a systemically toxic dose (10 mg/kg/day) 
14 days prior to mating and during conception; exposures of the predominant circulating metabolite 
(GS-441524) were 1.3 times the exposure in humans at the RHD. There were no effects on female 
reproductive performance (mating, fertility, and conception) at this dose level. 
 
In rats and rabbits, remdesivir demonstrated no adverse effect on embryofoetal development when 
administered to pregnant animals at systemic exposures (AUC) of the predominant circulating 
metabolite of remdesivir (GS-441524) that were up to 4 times the exposure in humans at the 
recommended human dose (RHD). 
 



23 

In rats, there were no adverse effects on pre- and post-natal development at systemic exposures (AUC) 
of the predominant circulating metabolite of remdesivir (GS-441524) that were similar to the exposure 
in humans at the recommended human dose (RHD). 
 
It is unknown if the active nucleoside analog triphosphate GS-443902 and the unidentified major 
human metabolite M27 are formed in rats and rabbits. The reproductive toxicity studies may therefore 
not be informative of potential risks associated with these metabolites. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Betadex Sulfobutyl Ether Sodium 
Hydrochloric acid (to adjust pH) 
Sodium hydroxide (to adjust pH) 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed or administered simultaneously with other medicinal 
products in the same dedicated line except those mentioned in section 6.6. 
 
6.3 Shelf life 
 
Unopened vials 
3 years 
 
Reconstituted and diluted solution for infusion 
Store diluted remdesivir solution for infusion up to 4 hours at below 25°C or 24 hours in a refrigerator 
(2°C – 8°C). 
 
6.4 Special precautions for storage 
 
No special precautions for storage. 
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
Type I clear glass vial, an elastomeric closure, and an aluminium overseal with a flip-off cap. 
 
Pack size: 1 vial 
 
6.6 Special precautions for disposal and other handling 
 
Prepare solution for infusion under aseptic conditions and on the same day as administration. 
Remdesivir should be inspected visually for particulate matter and discoloration prior to administration, 
whenever solution and container permit. Should either be observed, the solution should be discarded 
and fresh solution prepared. 
 
Remdesivir must be reconstituted with 19 mL sterile water for injections and diluted in sodium 
chloride 9 mg/mL (0.9%) solution for injection before being administered via intravenous infusion 
over 30 to 120 minutes. 
 



24 

Preparation of remdesivir solution for infusion 
 
Reconstitution 
Remove the required number of single-use vial(s) from storage. For each vial: 
• Aseptically reconstitute remdesivir powder for concentrate for solution for infusion by addition 

of 19 mL of sterile water for injections using a suitably sized syringe and needle per vial. 
◦ Discard the vial if a vacuum does not pull the sterile water for injections 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 solution 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. 

• Inspect the vial to ensure the container closure is free from defects and the solution is free of 
particulate matter. 

• Dilute immediately after reconstitution. 
 
Dilution 
Care should be taken 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 IV medicines immediately after 
preparation when possible. 
• Using Table 4, determine the volume of sodium chloride 9 mg/mL (0.9%) solution for injection 

to withdraw from the infusion bag. 
 
Table 4: Recommended dilution instructions – Reconstituted remdesivir powder for 

concentrate for solution for infusion 

Remdesivir 
dose 

Sodium chloride 
9 mg/mL (0.9%) 

infusion bag volume to 
be used 

Volume to be withdrawn 
and discarded from sodium 
chloride 9 mg/mL (0.9%) 

infusion bag 
Required volume of 

reconstituted remdesivir 
200 mg 
(2 vials) 

250 mL 40 mL 2 × 20 mL 
100 mL 40 mL 2 × 20 mL 

100 mg 
(1 vial) 

250 mL 20 mL 20 mL 
100 mL 20 mL 20 mL 

NOTE: 100 mL should be reserved for patients with severe fluid restriction, e.g. with ARDS or renal 
failure. 
 
• Withdraw and discard the required volume of sodium chloride 9 mg/ml from the bag using an 

appropriately sized syringe and needle per Table 4. 
• Withdraw the required volume of reconstituted remdesivir powder for concentrate for solution 

for infusion using an appropriately sized syringe per Table 4. Discard any unused portion 
remaining in the remdesivir vial. 

• Transfer the required volume of reconstituted remdesivir powder for concentrate for solution for 
infusion to the selected infusion bag. 

• Gently invert the bag 20 times to mix the solution in the bag. Do not shake. 
• The prepared solution is stable for 4 hours at room temperature (20°C to 25°C) or 24 hours in 

the refrigerator (2°C to 8°C) (including any time before dilution into intravenous infusion fluids). 
 
After infusion is complete, flush with at least 30 mL of sodium chloride 9 mg/ml. 
 
Disposal 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 



25 

7. MARKETING AUTHORISATION HOLDER

Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1459/002 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY} 

10. DATE OF REVISION OF THE TEXT

Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 

http://www.ema.europa.eu/


26 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 
AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE CONDITIONAL 
MARKETING AUTHORISATION 

 
 



27 

 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Gilead Sciences Ireland UC 
IDA Business & Technology Park 
Carrigtohill 
County Cork 
Ireland 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



28 

E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 
FOR THE CONDITIONAL MARKETING AUTHORISATION 

 
This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 
726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 
Description Due date 

In order to improve the impurity control strategy, lower the risk of 
contamination and assure comprehensive control throughout the lifecycle of 
the product, the MAH should, as agreed, re-define the starting materials of 
active substance synthesis, update all dossier documentation accordingly and 
implement the re-defined starting materials. The corresponding variation 
application must be submitted no later than by August 2020. 

June 2021 

In order to ensure batch to batch consistency the MAH should expand 
description of the active substance synthesis with more details regarding 
yields, process conditions, unambiguously specifying when each process 
stage is applicable, materials used and their specifications, and defining the 
batch size. Further, process parameter ranges should be further justified or 
tightened. 

August 2020 

In order to further substantiate the control strategy for the active substance 
the MAH should further elaborate the impurities discussion with regard to the 
formation of potential impurities in the current and redefined starting 
materials, the representativeness of the active substance used in the 
toxicological programme versus the commercial product, the contamination 
of the active substance by elemental impurities, and the proposed justification 
regarding the suitability and adequateness of the proposed controls. 

August 2020 

In order to improve the control strategy for the active substance the MAH 
should revise the active substance specification by including the parameter 
“microbial limits”, by revising the proposed limits for assay, impurities, 
residual solvents, and water in line with batch data and/ or relevant guidelines 
and Ph. Eur. as applicable, and confirm that the analytical method can control 
unspecified impurities GS-832698 and GS-832699. 

August 2020 

In order to ensure batch to batch consistency of the Powder for Concentrate 
for Solution for Infusion the MAH should expand the description of the 
manufacture of the finished product with more details, by providing the 
actual process validation report, by justifying the level of betadex sulfobutyl 
ether sodium, by clearly defining the batch size in line with process 
validation studies and per manufacturing site, by defining process parameters 
and acceptance criteria and by introducing additional in-process controls. 

August 2020 

In order to confirm the appropriateness of aseptic processing of sterile bulk 
product for the Powder for Concentrate for Solution for Infusion the MAH 
should submit the media fill results. 

August 2020 

In order to improve the control strategy for the Powder for Concentrate for 
Solution for Infusion product the MAH should revise the excipient and 
finished product specifications by revising the limits for assay, impurities and 
water content in line with batch and stability data, relevant Ph.Eur. 
requirements and guidelines, as applicable. 

August 2020 

In order to further substantiate the recommendations for reconstitution and 
storage of the Powder for Concentrate for Solution for Infusion product the 
MAH should submit in-use stability data for reconstituted Powder for 
Concentrate for Solution for Infusion diluted to 100ml with 0.9% saline 
solution. Moreover, a justification for the different dilution regimens for 
Powder for Concentrate for Solution for Infusion (dilute to 100ml or 250ml) 
and Concentrate for Solution for Infusion (dilute to 250ml) should be 
provided. The potential for handling errors should be considered. 

August 2020 



29 

In order to ensure batch to batch consistency of the Concentrate for Solution 
for Infusion the MAH should expand the description of the manufacture of 
the finished product with more  details by providing the actual process 
validation report, by justifying the level of betadex sulfobutyl ether sodium, 
by clearly defining the batch size in line with process validation studies and 
per manufacturing site, by defining process parameters and acceptance 
criteria, by introducing additional in-process controls and by providing 
additional batch data. 

August 2020 

In order to confirm the appropriateness of aseptic processing of sterile bulk 
product for Concentrate for Solution for Infusion the MAH should submit the 
media fill results. 

August 2020 

In order to improve the control strategy for the Concentrate for Solution for 
Infusion product the MAH should revise the excipient and finished product 
specifications by revising the limits for assay, impurities and endotoxins in 
line with batch and stability data, relevant Ph. Eur. requirements and 
guidelines, as applicable. 

August 2020 

In order to confirm the efficacy and safety of remdesivir, the MAH should 
submit the final clinical study report (CSR) of Study CO-US-540-5776 
(NIAID-ACTT1). 

December 2020 

In order to confirm the efficacy and safety of remdesivir in patients on 
IMV/ECMO, the MAH should submit the published final D28 mortality data 
by ordinal scale categories of Study CO-US-540-5776 (NIAID-ACTT1). In 
addition, the MAH should discuss potential imbalance in the use of 
corticosteroids and effect modification in Study CO-US-540-5776. 

August 2020 

In order to confirm the efficacy and safety of remdesivir, the MAH should 
submit the final CSR for Part A (Day 28) of Study GS-US-540-5773.  

December 2020 

In order to confirm the efficacy and safety of remdesivir, the MAH should 
submit the final CSR for Part A (Day 28) of Study GS-US-540-5774.  

December 2020 

In order to confirm the safety profile of remdesivir, the MAH should submit 
in Module 2.7.4 an analysis of all available safety data from clinical trials 
CO-US-540-5776, GS-US-540-5773, GS-US-540-5774 and CO-US-540-
5758 when completed, including case narratives, detailed information about 
adverse reaction and exposure data as well as an analysis of occurrence and 
aggravation of AEs, SAEs and ADRs are associated with increasing 
exposure. 

December 2020 

 



30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



32 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON (CONCENTRATE FOR SOLUTION FOR INFUSION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veklury 100 mg concentrate for solution for infusion 
remdesivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 100 mg remdesivir (5 mg/mL). 
 
 
3. LIST OF EXCIPIENTS 
 
It also contains betadex sulfobutyl ether sodium, water for injections, hydrochloric acid and sodium 
hydroxide, see leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Concentrate for solution for infusion 
1 vial 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous use after dilution. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
 
 



33 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1459/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
QR code to be included www.veklury.eu 



34 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL (CONCENTRATE FOR SOLUTION FOR INFUSION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Veklury 100 mg sterile concentrate 
remdesivir 
For IV use after dilution. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
20 mL 
(5 mg/mL) 
 
 
6. OTHER 
 
Store in a refrigerator. 



35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
VIAL CARTON (POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Veklury 100 mg powder for concentrate for solution for infusion 
remdesivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each vial contains 100 mg remdesivir (5 mg/mL after reconstitution). 
 
 
3. LIST OF EXCIPIENTS 
 
It also contains betadex sulfobutyl ether sodium, hydrochloric acid and sodium hydroxide, see leaflet 
for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for concentrate for solution for infusion 
1 vial 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
For intravenous use after reconstitution and dilution. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



36 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/20/1459/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
QR code to be included www.veklury.eu 



37 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL (POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Veklury 100 mg powder for concentrate 
remdesivir 
For IV use after reconstitution and dilution. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mg/mL after reconstitution 
 
 
6. OTHER 
 
 



38 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



39 

Package leaflet: Information for the patient 
 

Veklury 100 mg concentrate for solution for infusion 
remdesivir 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you are given this medicine, because it contains important 
information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or nurse. 
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Veklury is and what it is used for 
2. What you need to know before you are given Veklury 
3. How Veklury is given to you 
4. Possible side effects 
5. How to store Veklury 
6. Contents of the pack and other information 
 
 
1. What Veklury is and what it is used for 
 
The active substance in is remdesivir. It is an antiviral medicine used for treating COVID-19. 
 
COVID-19 is caused by a virus called a coronavirus. Veklury stops the virus multiplying in cells and 
this stops the virus multiplying in the body. This can help your body to overcome the virus infection, 
and may help you get better faster. 
 
Veklury will be given to people with COVID-19. It is suitable for adults and adolescents (aged 12 and 
over who weigh 40 kg or more). It will only be given to patients who have pneumonia, and need extra 
oxygen to help them breathe. 
 
 
2. What you need to know before you are given Veklury 
 
You will not usually be given Veklury: 
• if you are allergic to remdesivir, or any of the other ingredients of this medicine (listed in 

section 6) 
➔ Talk to your doctor or nurse as soon as possible, if this applies to you. 
 
Warnings and precautions 
Talk to your doctor or nurse before starting on Veklury: 
• if you have liver problems. Some people developed increased liver enzymes when given 

Veklury. Your doctor will do blood tests before starting treatment to check whether you can be 
given it safely. 

• if you have kidney problems. Some people with severe kidney problems may not be given this 
medicine. Your doctor will do blood tests to check whether you can be given it safely. 

 



40 

Reactions following the infusion 
Veklury can cause allergic reactions or reactions following the infusion. Symptoms can include: 

• Changes to blood pressure or heart rate. 
• Low oxygen level in blood 
• High temperature 
• Shortness of breath, wheezing 
• Swelling of the face, lips, tongue or throat (angioedema) 
• Rash 
• Feeling sick (nausea) 
• Sweating 
• Shivering. 

 
➔ Tell your doctor if you get any of these signs or symptoms. 
 
Blood tests before and during treatment 
If you are prescribed Veklury, you will be given blood tests before treatment starts. Patients being 
treated with Veklury will have blood tests during their treatment as determined by their health care 
provider. These tests are to check for kidney or liver problems. Veklury will be stopped if your kidney 
or liver show signs of damage during treatment. See Possible side effects, below. 
 
Children and adolescents 
Veklury is not to be given to children under 12 years who weigh less than 40 kg. Not enough is known 
for it to be given to these children. 
 
Other medicines and Veklury 
Tell your doctor or nurse about any other medicines you are taking, or have recently taken. 
 
Do not take chloroquine or hydroxychloroquine at the same time as remdesivir. 
 
Certain medicines e.g. midazolam or pitavastatin should be taken at least 2 hours after Veklury as 
Veklury can affect the way they work. 
 
Veklury may affect the way certain medicines (e.g. theophylline or midazolam) work. 
 
➔ Tell your doctor if you are taking any of these medicines 
 
Veklury can be used with dexamethasone. 
 
It is not yet known if Veklury affects other medicines, or is affected by them. Your healthcare team 
will monitor you for signs of medicines affecting each other. 
 
Pregnancy and breast-feeding 
Tell your doctor or nurse if you are pregnant, or if you might be. There is not enough information 
to be sure that Veklury is safe for use in pregnancy. Veklury will only be given if the potential benefits 
of treatment outweigh the potential risks to the mother and the unborn child. You must use effective 
contraception while having remdesivir treatment. 
 
Tell your doctor or nurse if you are breast-feeding. It is not yet known whether Veklury or the 
COVID-19 virus pass into human breast milk, or what the effects might be on the baby or milk 
production. Your doctor will help you decide whether to continue breast-feeding or to start treatment 
with Veklury. You will need to consider the potential benefits of treatment for you, compared with the 
health benefits and risks of breast-feeding for your baby. 
 
Driving and using machines 
Veklury is not expected to have any effect on your ability to drive. 
 



41 

Veklury contains a cyclodextrin 
This medicine contains 6 g betadex sulfobutyl ether sodium in each 100 mg dose of Veklury (12 g in 
the starting dose). This ingredient is a cyclodextrin emulsifier that helps the medicine to disperse in the 
body. 
 
 
3. How Veklury is given to you 
 
Veklury will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) 
lasting 30 to 120 minutes, once a day. You will be closely monitored during your treatment. 
 
The recommended dose is: 
• a single starting dose of 200 mg on day 1 
• then daily doses of 100 mg starting on day 2. 
 
You will be given Veklury every day for at least 5 days. Your doctor may extend the treatment up to 
a total of 10 days. 
 
See the Instructions for healthcare professionals which give details on how the Veklury infusion is 
given. 
 
If you are given more or less Veklury than you should be 
As Veklury is only given to you by a healthcare provider, it is unlikely that you will be given too much 
or too little. If you have been given an extra dose, or missed one, tell your nurse or doctor straight 
away. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common side effects 
(these may affect more than 1 in 10 patients) 
• Blood tests may show an increase in liver enzymes, called transaminases. 
 
Common side effects 
(these may affect up to 1 in 10 patients) 
• Headache 
• Feeling sick (nausea) 
• Rash 
 
Rare side effects 
(these may affect up to 1 in 1000 patients) 
• Allergic reactions or reactions following the infusion. Symptoms can include: 

• Changes to blood pressure or heart rate 
• Low oxygen level in blood 
• High temperature 
• Shortness of breath, wheezing 
• Swelling of the face, lips, tongue or throat (angioedema) 
• Rash 
• Feeling sick (nausea) 
• Sweating 
• Shivering 

 



42 

Reporting of side effects 
If you notice any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Veklury 
 
• Before use, store unopened Veklury concentrated solution in a refrigerator until the day it is 

needed. Before diluting it, allow the concentrated solution to come up to room temperature. 
• Once diluted, Veklury should be used immediately. If necessary, bags of diluted solution can be 

stored for up to 4 hours below 25°C, or for up to 24 hours in a refrigerator. Do not allow more 
than 24 hours between dilution and administration. 

 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine if you see particles in the vial, or if the solution does not appear colorless to 
yellow. 
 
 
6. Contents of the pack and other information 
 
What Veklury contains 
• The active substance is remdesivir. Each vial contains 100 mg. 
• The other ingredients are: betadex sulfobutyl ether sodium, hydrochloric acid, sodium 

hydroxide and water for injections. 
 
What Veklury looks like and contents of the pack 
Veklury 100 mg concentrate for solution for infusion is a clear, colourless to yellow, aqueous-based 
concentrated solution, to be diluted into sodium chloride solution prior to administration by 
intravenous infusion. It is supplied in a single-use clear glass vial. 
 
Veklury is available in cartons containing 1 vial. 
 
Marketing Authorisation Holder and Manufacturer 
Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Gilead Sciences Belgium SPRL-BVBA 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Lietuva 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

България 
Gilead Sciences Ireland UC 
Тел.: + 353 (0) 1 686 1888 
 

Luxembourg/Luxemburg 
Gilead Sciences Belgium SPRL-BVBA 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Česká republika 
Gilead Sciences s.r.o. 
Tel: + 420 910 871 986 
 

Magyarország 
Gilead Sciences Ireland UC 
Tel.: + 353 (0) 1 686 1888 
 

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43 

Danmark 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Malta 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Deutschland 
Gilead Sciences GmbH 
Tel: + 49 (0) 89 899890-0 
 

Nederland 
Gilead Sciences Netherlands B.V. 
Tel: + 31 (0) 20 718 36 98 
 

Eesti 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 

Norge 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Ελλάδα 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Österreich 
Gilead Sciences GesmbH 
Tel: + 43 1 260 830 
 

España 
Gilead Sciences, S.L. 
Tel: + 34 91 378 98 30 
 

Polska 
Gilead Sciences Poland Sp. z o.o. 
Tel.: + 48 22 262 8702 
 

France 
Gilead Sciences 
Tél : + 33 (0) 1 46 09 41 00 
 

Portugal 
Gilead Sciences, Lda. 
Tel: + 351 21 7928790 
 

Hrvatska 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

România 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ireland 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 214 825 999 
 

Slovenija 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ísland 
Gilead Sciences Sweden AB 
Sími: + 46 (0) 8 5057 1849 
 

Slovenská republika 
Gilead Sciences Slovakia s.r.o. 
Tel: + 421 232 121 210 
 

Italia 
Gilead Sciences S.r.l. 
Tel: + 39 02 439201 
 

Suomi/Finland 
Gilead Sciences Sweden AB 
Puh/Tel: + 46 (0) 8 5057 1849 
 

Κύπρος 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Sverige 
Gilead Sciences Sweden AB 
Tel: + 46 (0) 8 5057 1849 
 

Latvija 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

United Kingdom 
Gilead Sciences Ltd. 
Tel: + 44 (0) 8000 113 700 
 

 
This leaflet was last revised in . 
 
This medicine has been given ‘conditional approval’. This means that there is more evidence to come 
about this medicine. 
The European Medicines Agency will review new information on this medicine at least every year and 
this leaflet will be updated as necessary. 
 



44 

Other sources of information 
 
Scan the code below with a mobile device to get this information in different languages. 
 
QR code to be included www.veklury.eu 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
------------------------------------------------------------------------------------------------------------------------ 
 
The following information is intended for healthcare professionals only. 
Please refer to the Summary of Product Characteristics for further information. 
 

Instructions for healthcare professionals 
 

Veklury 100 mg concentrate for solution for infusion 
remdesivir 

 
Each single-use vial contains 100 mg of remdesivir (5 mg/mL) as a clear, colorless to yellow, aqueous-
based concentrate for dilution. 
 
Summary of treatment 
 
Veklury is for adults and adolescents (aged 12 years and older and weighing 40 kg or more) with 
pneumonia, who require supplemental oxygen. 
 
Veklury should be administered by intravenous infusion in a total volume of 250 mL 0.9% sodium 
chloride over 30 to 120 minutes. 
 
The recommended dosage is: 
• a single loading dose of 200 mg on day 1 
• once daily maintenance doses of 100 mg starting on day 2. 
 
The recommended course of treatment is: 
• one infusion every day for at least 5 days. Treatment can be extended to a total of up to 

10 days. 
 
The concentrated solution must be diluted with sodium chloride solution 9 mg/mL (0.9%) under 
aseptic conditions. Administer the diluted solution immediately. 
 
All patients must have their liver function and renal function checked before starting treatment and as 
clinically appropriate during treatment. Serum chemistries, hematology, ALT, AST, bilirubin and 
alkaline phosphatase must be checked as clinically appropriate. 
 
Monitor the patient for side effects during and after the infusion. See below for details on reporting of 
side effects. 
 
Dilute the concentrate with sodium chloride solution 
 
Veklury concentrated solution must be diluted with sodium chloride 9 mg/mL (0.9%) solution for 
injection under aseptic conditions. 
 

http://www.ema.europa.eu/


45 

Remove the required number of single-use vial(s) from storage. For each vial: 
• Allow to warm to room temperature (20°C to 25°C). 
• Inspect the vial to ensure the container closure is free from defects and the concentrate for 

solution for infusion is free of particulate matter. 
• Using Table 1, determine the volume of sodium chloride 9 mg/mL (0.9%) to withdraw from the 

infusion bag. 
 
Table 1: Dilution instructions 

Dose 
Size of infusion 
bag to be used 

How much sodium 
chloride solution to 

withdraw and 
discard from 
infusion bag 

Volume of 
concentrated 

Veklury 
200 mg 
(2 vials) 250 mL 40 mL 2 × 20 mL 

100 mg 
(1 vial) 250 mL 20 mL 20 mL 

 
• Withdraw and discard the required volume of sodium chloride solution from the infusion bag 

using an appropriately sized syringe and needle. See Table 1. 
• Pull the syringe plunger rod back to fill the syringe with approximately 10 mL of air. 
• Inject the air into the Veklury vial above the level of the solution. 
• Invert the vial and withdraw the required volume of Veklury from the vial into the syringe. See 

Table 1. The last 5 mL requires more force to withdraw. 
• Transfer the concentrated solution to the infusion bag. 
• Gently invert the bag 20 times to mix the solution in the bag. Do not shake. 
• Administer the diluted solution immediately, or as soon as possible after preparation. The 

diluted solution is stable for 4 hours at room temperature (20°C to 25°C) or 24 hours in a fridge 
(2°C to 8°C), from the time the solution is diluted. 

• Discard any unused portion remaining in the Veklury vial. 
 
Administer the infusion 
 
• Administer the diluted solution over 30 to 120 minutes at the rate described in Table 2. 
• After infusion is complete, flush with at least 30 mL of 9 mg/mL (0.9%) sodium chloride 

solution. 
• The diluted solution should not be administered simultaneously with any other medication in the 

same intravenous line. The compatibility of Veklury with IV solutions and medications other 
than sodium chloride is not known. 

 
Table 2: Rate of infusion 

Infusion bag 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 
 
Monitor and report side effects 
 
• Monitor the patient for side effects during and after the infusion. 
• Report side effects via the national reporting system listed in Appendix V. 
 
Store Veklury safely 
 
• Before use, store Veklury vials in a fridge (2°C to 8°C) until they are required. Do not use after 

expiry date, marked on the vials/cartons after the letters EXP. 

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46 

• Veklury concentrate is a clear, colorless to yellow, aqueous-based concentrated solution. 
• Before dilution, allow Veklury vials to warm up to room temperature (20°C to 25°C). 
• Once diluted, Veklury should be administered immediately. If necessary, bags of diluted 

solution can be stored for up to 4 hours at room temperature (20°C to 25°C), or for up to 
24 hours in a fridge (2°C to 8°C). Do not leave more than 24 hours between dilution and 
administration. 

 
Do not reuse or save unused Veklury concentrated solution or diluted solution. 
 
Information in other languages 
 
• Scan the code below with a mobile device to get the information in different languages. 
 
QR code to be included www.veklury.eu 
 
This leaflet was last revised in . 



47 

 
 

Package leaflet: Information for the patient 
 

Veklury 100 mg powder for concentrate for solution for infusion 
remdesivir 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you are given this medicine, because it contains important 
information for you. 
• Keep this leaflet. You may need to read it again. 
• If you have any further questions, ask your doctor or nurse. 
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects 

not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Veklury is and what it is used for 
2. What you need to know before you are given Veklury 
3. How Veklury is given to you 
4. Possible side effects 
5. How to store Veklury 
6. Contents of the pack and other information 
 
 
1. What Veklury is and what it is used for 
 
The active substance in is remdesivir. It is an antiviral medicine used for treating COVID-19. 
 
COVID-19 is caused by a virus called a coronavirus. Veklury stops the virus multiplying in cells and 
this stops the virus multiplying in the body. This can help your body to overcome the virus infection, 
and may help you get better faster. 
 
Veklury will be given to people with COVID-19. It is suitable for adults and adolescents (aged 12 and 
over who weigh 40 kg or more). It will only be given to patients who have pneumonia, and need extra 
oxygen to help them breathe. 
 
 
2. What you need to know before you are given Veklury 
 
You will not usually be given Veklury: 
• if you are allergic to remdesivir, or any of the other ingredients of this medicine (listed in 

section 6) 
➔ Talk to your doctor or nurse as soon as possible, if this applies to you. 
 
Warnings and precautions 
Talk to your doctor or nurse before starting on Veklury: 
• if you have liver problems. Some people developed increased liver enzymes when given 

Veklury. Your doctor will do blood tests before starting treatment to check whether you can be 
given it safely. 

• if you have kidney problems. Some people with severe kidney problems may not be given this 
medicine. Your doctor will do blood tests to check whether you can be given it safely. 

 



48 

Reactions following the infusion 
Veklury can cause allergic reactions or reactions following the infusion. Symptoms can include: 

• Changes to blood pressure or heart rate. 
• Low oxygen level in blood 
• High temperature 
• Shortness of breath, wheezing 
• Swelling of the face, lips, tongue or throat (angioedema) 
• Rash 
• Feeling sick (nausea) 
• Sweating 
• Shivering. 

 
➔ Tell your doctor if you get any of these signs or symptoms 
 
Blood tests before and during treatment 
If you are prescribed Veklury, you will be given blood tests before treatment starts. Patients being 
treated with Veklury will have blood tests during their treatment as determined by their health care 
provider. These tests are to check for kidney or liver problems. Veklury will be stopped if your kidney 
or liver show signs of damage during treatment. See Possible side effects, below. 
 
Children and adolescents 
Veklury is not to be given to children under 12 years who weigh less than 40 kg. Not enough is known 
for it to be given to these children. 
 
Other medicines and Veklury 
Tell your doctor or nurse about any other medicines you are taking, or have recently taken. 
 
Do not take chloroquine or hydroxychloroquine at the same time as remdesivir. 
 
Certain medicines e.g. midazolam or pitavastatin should be taken at least 2 hours after Veklury as 
Veklury can affect the way they work. 
 
Veklury may affect the way certain medicines (e.g. theophylline or midazolam) work. 
 
➔ Tell your doctor if you are taking any of these medicines 
 
Veklury can be used with dexamethasone. 
 
It is not yet known if Veklury affects other medicines, or is affected by them. Your healthcare team 
will monitor you for signs of medicines affecting each other. 
 
Pregnancy and breast-feeding 
Tell your doctor or nurse if you are pregnant, or if you might be. There is not enough information 
to be sure that Veklury is safe for use in pregnancy. Veklury will only be given if the potential benefits 
of treatment outweigh the potential risks to the mother and the unborn child. You must use effective 
contraception while having remdesivir treatment. 
 
Tell your doctor or nurse if you are breast-feeding. It is not yet known whether Veklury or the 
COVID-19 virus pass into human breast milk, or what the effects might be on the baby or milk 
production. Your doctor will help you decide whether to continue breast-feeding or to start treatment 
with Veklury. You will need to consider the potential benefits of treatment for you, compared with the 
health benefits and risks of breast-feeding for your baby. 
 
Driving and using machines 
Veklury is not expected to have any effect on your ability to drive. 
 



49 

Veklury contains a cyclodextrin 
This medicine contains 3 g betadex sulfobutyl ether sodium in each 100 mg dose of Veklury (6 g in the 
starting dose). This ingredient is a cyclodextrin emulsifier that helps the medicine to disperse in the 
body. 
 
 
3. How Veklury is given to you 
 
Veklury will be given to you by a nurse or doctor, as a drip into a vein (an intravenous infusion) 
lasting 30 to 120 minutes, once a day. You will be closely monitored during your treatment. 
 
The recommended dose is: 
• a single starting dose of 200 mg on day 1 
• then daily doses of 100 mg starting on day 2. 
 
You will be given Veklury every day for at least 5 days. Your doctor may extend the treatment up to 
a total of 10 days. 
 
See the Instructions for healthcare professionals which give details on how the Veklury infusion is 
given. 
 
If you are given more or less Veklury than you should be 
As Veklury is only given to you by a healthcare provider, it is unlikely that you will be given too much 
or too little. If you have been given an extra dose, or missed one, tell your nurse or doctor straight 
away. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Very common side effects 
(these may affect more than 1 in 10 patients) 
• Blood tests may show an increase in liver enzymes, called transaminases. 
 
Common side effects 
(these may affect up to 1 in 10 patients) 
• Headache 
• Feeling sick (nausea) 
• Rash 
 
Rare side effects 
(these may affect up to 1 in 1000 patients) 
• Allergic reactions or reactions following the infusion. Symptoms can include: 

• Changes to blood pressure or heart rate 
• Low oxygen level in blood 
• High temperature 
• Shortness of breath, wheezing 
• Swelling of the face, lips, tongue or throat (angioedema) 
• Rash 
• Feeling sick (nausea) 
• Sweating 
• Shivering 

 



50 

Reporting of side effects 
If you notice any side effects, talk to your doctor or nurse. This includes any possible side effects not 
listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects, you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Veklury 
 
• Before use, this medicinal product does not require any special storage conditions. 
• Once reconstituted, Veklury should be diluted immediately. 
• Once diluted, Veklury should be used immediately. If necessary, bags of diluted solution can be 

stored for up to 4 hours below 25°C, or for up to 24 hours in a refrigerator. Do not allow more 
than 24 hours between dilution and administration. 

 
Keep this medicine out of the sight and reach of children. 
 
 
6. Contents of the pack and other information 
 
What Veklury contains 
• The active substance is remdesivir. Each vial contains 100 mg. 
• The other ingredients are: betadex sulfobutyl ether sodium, hydrochloric acid and sodium 

hydroxide. 
 
What Veklury looks like and contents of the pack 
Veklury 100 mg powder for concentrate for solution for infusion is a white, off-white to yellow 
powder, to be reconstituted and then diluted into sodium chloride solution prior to administration by 
intravenous infusion. It is supplied in a single-use clear glass vial. 
 
Veklury is available in cartons containing 1 vial. 
 
Marketing Authorisation Holder and Manufacturer 
Gilead Sciences Ireland UC 
Carrigtohill 
County Cork, T45 DP77 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
Gilead Sciences Belgium SPRL-BVBA 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Lietuva 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

България 
Gilead Sciences Ireland UC 
Тел.: + 353 (0) 1 686 1888 
 

Luxembourg/Luxemburg 
Gilead Sciences Belgium SPRL-BVBA 
Tél/Tel: + 32 (0) 24 01 35 50 
 

Česká republika 
Gilead Sciences s.r.o. 
Tel: + 420 910 871 986 
 

Magyarország 
Gilead Sciences Ireland UC 
Tel.: + 353 (0) 1 686 1888 
 

Danmark 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Malta 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

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51 

Deutschland 
Gilead Sciences GmbH 
Tel: + 49 (0) 89 899890-0 
 

Nederland 
Gilead Sciences Netherlands B.V. 
Tel: + 31 (0) 20 718 36 98 
 

Eesti 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 

Norge 
Gilead Sciences Sweden AB 
Tlf: + 46 (0) 8 5057 1849 
 

Ελλάδα 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Österreich 
Gilead Sciences GesmbH 
Tel: + 43 1 260 830 
 

España 
Gilead Sciences, S.L. 
Tel: + 34 91 378 98 30 
 

Polska 
Gilead Sciences Poland Sp. z o.o. 
Tel.: + 48 22 262 8702 
 

France 
Gilead Sciences 
Tél : + 33 (0) 1 46 09 41 00 
 

Portugal 
Gilead Sciences, Lda. 
Tel: + 351 21 7928790 
 

Hrvatska 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

România 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ireland 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 214 825 999 
 

Slovenija 
Gilead Sciences Ireland UC 
Tel: + 353 (0) 1 686 1888 
 

Ísland 
Gilead Sciences Sweden AB 
Sími: + 46 (0) 8 5057 1849 
 

Slovenská republika 
Gilead Sciences Slovakia s.r.o. 
Tel: + 421 232 121 210 
 

Italia 
Gilead Sciences S.r.l. 
Tel: + 39 02 439201 
 

Suomi/Finland 
Gilead Sciences Sweden AB 
Puh/Tel: + 46 (0) 8 5057 1849 
 

Κύπρος 
Gilead Sciences Ελλάς Μ.ΕΠΕ. 
Τηλ: + 30 210 8930 100 
 

Sverige 
Gilead Sciences Sweden AB 
Tel: + 46 (0) 8 5057 1849 
 

Latvija 
Gilead Sciences Poland Sp. z o.o. 
Tel: + 48 22 262 8702 
 

United Kingdom 
Gilead Sciences Ltd. 
Tel: + 44 (0) 8000 113 700 
 

 
This leaflet was last revised in . 
 
This medicine has been given ‘conditional approval’. This means that there is more evidence to come 
about this medicine. 
The European Medicines Agency will review new information on this medicine at least every year and 
this leaflet will be updated as necessary. 
 
Other sources of information 
 
Scan the code below with a mobile device to get this information in different languages. 
 
QR code to be included www.veklury.eu 



52 

 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
------------------------------------------------------------------------------------------------------------------------ 
 
The following information is intended for healthcare professionals only. 
Please refer to the Summary of Product Characteristics for further information. 
 

Instructions for healthcare professionals 
 

Veklury 100 mg powder for concentrate for solution for infusion 
remdesivir 

 
Each single-use vial contains 100 mg of remdesivir as a white to off-white to yellow powder for 
reconstitution and dilution. 
 
Summary of treatment 
 
Veklury is for adults and adolescents (aged 12 years and older and weighing 40 kg or more) with 
pneumonia, who require supplemental oxygen. 
 
Veklury should be administered by intravenous infusion in a total volume of 100 mL or 250 mL 0.9% 
sodium chloride over 30 to 120 minutes. 
 
The recommended dosage is: 
• a single loading dose of 200 mg on day 1 
• once daily maintenance doses of 100 mg starting on day 2. 
 
The recommended course of treatment is: 
• one infusion every day for at least 5 days. Treatment can be extended to a total of up to 

10 days. 
 
The powder must be reconstituted with water for injections, and then diluted with sodium chloride 
solution 9 mg/mL (0.9%) under aseptic conditions. Administer the diluted solution immediately. 
 
All patients must have their liver function and renal function checked before starting treatment and as 
clinically appropriate during treatment. Serum chemistries, hematology, ALT, AST, bilirubin and 
alkaline phosphatase must be checked as clinically appropriate. 
 
Monitor the patient for side effects during and after the infusion. See below for details on reporting of 
side effects. 
 
Reconstitute the powder 
 
For each single-use vial, the powder must be reconstituted and then diluted under aseptic conditions. 
• Add 19 mL of sterile water for injections to the vial, using a suitably sized syringe and needle 

for each vial. This produces a solution of 5 mg/mL of remdesivir. 
◦ Discard the vial if a vacuum does not pull the sterile water 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 solution 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. 

• Inspect the vial to ensure the container closure is free from defects. 

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53 

• The solution should only be used if it is clear and free from particles. 
• Dilute immediately after reconstitution. 
 
Dilute the concentrate with sodium chloride solution 
 
Reconstituted Veklury must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection 
under aseptic conditions. 
 
Using Table 1, decide how much sodium chloride solution 9 mg/mL (0.9%) to withdraw from the 
infusion bag. 
 
Table 1: Dilution instructions 

Dose 
Size of infusion 
bag to be used 

How much sodium 
chloride solution to 

withdraw and 
discard from 
infusion bag 

Volume of 
reconstituted 

Veklury 
200 mg 
(2 vials) 

250 mL 40 mL 2 × 20 mL 
100 mL 40 mL 2 × 20 mL 

100 mg 
(1 vial) 

250 mL 20 mL 20 mL 
100 mL 20 mL 20 mL 

Note: 100 mL infusion should only be used for patients with severe fluid restrictions. 
 
• Withdraw and discard the required volume of sodium chloride solution from the infusion bag 

using an appropriately sized syringe and needle. See Table 1. 
• Withdraw the required volume of reconstituted Veklury from the vial using an appropriately 

sized syringe. See Table 1. 
• Transfer the reconstituted Veklury to the infusion bag. 
• Gently invert the bag 20 times to mix the solution in the bag. Do not shake. 
• Administer the diluted solution immediately, or as soon as possible after preparation. The 

diluted solution is stable for 4 hours at room temperature (20°C to 25°C) or 24 hours in a fridge 
(2°C to 8°C), from the time the powder is reconstituted. 

 
Administer the infusion 
 
• Administer the diluted solution over 30 to 120 minutes at the rate described in Table 2. 
• After infusion is complete, flush with at least 30 mL of 9 mg/mL (0.9%) sodium chloride 

solution. 
• The diluted solution should not be administered simultaneously with any other medicines in the 

same intravenous line. The compatibility of Veklury with IV solutions and medications other 
than sodium chloride is not known. 

 
Table 2: Rate of infusion 

Infusion bag 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 
 
Monitor and report side effects 
 
• Monitor the patient for side effects during and after the infusion. 
• Report side effects via the national reporting system listed in Appendix V. 

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54 

 
Store Veklury safely 
 
• Before use, this medicinal product does not require any special storage conditions. Do not use 

after expiry date, marked on the vials/cartons after the letters EXP. 
• Veklury powder appears white to off-white to yellow. The color does not affect product stability. 
• Once reconstituted, Veklury should be diluted immediately. 
• Once diluted, Veklury should be administered immediately. If necessary, bags of diluted 

solution can be stored for up to 4 hours at room temperature (20°C to 25°C), or for up to 
24 hours in a fridge (2°C to 8°C). Do not leave more than 24 hours between dilution and 
administration. 

 
Do not reuse or save unused Veklury powder, reconstituted solution or diluted solution. 
 
Information in other languages 
 
• Scan the code below with a mobile device to get the information in different languages. 
 
QR code to be included www.veklury.eu 
 
This leaflet was last revised in . 



55 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX IV 
 

CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING 
AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY 

 
 



56 

Conclusions presented by the European Medicines Agency on: 
 
• Conditional marketing authorisation 
 
The CHMP having considered the application is of the opinion that the risk-benefit balance is 
favourable to recommend the granting of the conditional marketing authorisation as further explained 
in the European Public Assessment Report. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET
	CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY