FACT SHEET FOR HEALTH CARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF VEKLURY® (remdesivir)
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use
Authorization (EUA) to permit the emergency use of the unapproved product
Veklury (remdesivir) for treatment of suspected or laboratory confirmed
coronavirus disease 2019 (COVID-19) in adults and pediatric patients
hospitalized with severe disease. Severe disease is defined as patients with an
oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or
requiring mechanical ventilation or requiring extracorporeal membrane
oxygenation (ECMO).

This EUA is for the use of Veklury (remdesivir) to treat COVID-19.
Veklury must be administered by intravenous (IV) infusion.
Health care providers must submit a report on all medication errors and ALL
SERIOUS ADVERSE EVENTS related to Veklury. See Sections 8 and 9 of
the Full EUA Prescribing Information for reporting requirements.
• See the Full EUA Prescribing Information for complete dosage,
administration, and preparation instructions.
• Veklury (remdesivir) is available as a lyophilized powder and concentrated
solution.
• The recommended dose for adults and pediatric patients weighing 40 kg
and higher is a single loading dose of 200 mg on Day 1 followed by oncedaily maintenance doses of 100 mg from Day 2.
• For pediatric patients weighing 3.5 kg to less than 40 kg, only use
Veklury for injection, 100 mg, lyophilized powder. The recommended
dose for pediatric patients weighing 3.5 kg to less than 40 kg is a single
loading dose of Veklury 5 mg/kg on Day 1 followed by Veklury 2.5 mg/kg
once daily from Day 2 (see Full EUA Prescribing Information, subsection
2.3 Recommended Dosage in Pediatric Patients).
• The optimal duration of treatment for COVID-19 is unknown.
• For patients requiring invasive mechanical ventilation and/or
extracorporeal membrane oxygenation (ECMO), the recommended total
treatment duration is 10 days.
• For patients not requiring invasive mechanical ventilation and/or ECMO,
the recommended total treatment duration is 5 days. If a patient does not
demonstrate clinical improvement, treatment may be extended for up to 5
additional days for a total treatment duration of up to 10 days.
• Administer Veklury via IV infusion over 30 to 120 minutes.
For information on clinical trials that are testing the use of Veklury in COVID19, please see www.clinicaltrials.gov.
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INSTRUCTIONS FOR ADMINISTRATION
This section provides essential information on the unapproved use of Veklury
(remdesivir), an unapproved drug, to treat suspected or laboratory confirmed
COVID-19 in adults and pediatric patients hospitalized with severe disease under
this EUA. For more information, see the long version of the “Fact Sheet for
Health Care Providers,” available at https://www.fda.gov/emergencypreparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization.
Contraindications
Veklury is contraindicated in patients with known hypersensitivity to any
ingredient of Veklury.
Dosing
Patient Selection and Treatment Initiation
• Empiric treatment of hospitalized patients with suspected COVID-19 can
be considered pending laboratory confirmation of SARS-CoV-2 infection.
• Veklury can be used at any time after onset of symptoms in hospitalized
patients.
• Adult and pediatric patients greater than 28 days old) must have an
estimated glomerular filtration rate (eGFR) determined and full-term
neonates (at least 7 days to less than or equal to 28 days old) must have
serum creatinine determined before dosing and daily while receiving
Veklury.
• Hepatic laboratory testing should be performed in all patients prior to
starting Veklury and daily while receiving Veklury.
Adult Patients
• The recommended dosage of Veklury for adults is a single loading dose of
200 mg on Day 1 followed by once-daily maintenance doses of 100 mg
from Day 2.
• For patients requiring invasive mechanical ventilation and/or ECMO, the
recommended total treatment duration is 10 days.
• For patients not requiring invasive mechanical ventilation and/or ECMO,
the recommended total treatment duration is 5 days. If a patient does not
demonstrate clinical improvement, treatment may be extended for up to 5
additional days for a total treatment duration of up to 10 days.
• Administer Veklury via IV infusion over 30 to 120 minutes.
Pediatric Patients
• For pediatric patients weighing 3.5 kg to less than 40 kg, use Veklury
(remdesivir) for injection, 100 mg, lyophilized powder only. Veklury
3
injection, 100 mg/20 mL (5 mg/mL), should not be used for pediatric
patients weighing 3.5 kg to less than 40 kg due to the higher amount of
sulfobutylether-β-cyclodextrin sodium salt [SBECD] present and resulting
higher tonicity of the solution concentrate compared to the lyophilized
formulation. Administer a body weight-based dosing regimen of a single
loading dose of Veklury 5 mg/kg on Day 1 followed by Veklury
2.5 mg/kg once daily from Day 2 (see Full EUA Prescribing Information,
subsection 2.3 Recommended Dosage in Pediatric Patients).
• The recommended dosage of Veklury for pediatric patients weighing 40 kg
and higher is the adult dosage regimen of a single loading dose of
200 mg on Day 1 followed by once-daily maintenance doses of 100 mg
from Day 2 (see Full EUA Prescribing Information, subsection 2.3
Recommended Dosage in Pediatric Patients). Table 1 below provides the
recommended dosage and dosage form in pediatric patients.
Table 1: Recommended Dosage Form and Dosage in Pediatric
Patients
Body weight Recommended dosage form
Loading
dose
(on Day 1)
Maintenance
dose
(from Day 2)
3.5 kg to
less than 40 kg
Veklury (remdesivir)
Lyophilized Powder for
Injection Only
5 mg/kg 2.5 mg/kg
40 kg and higher
Veklury (remdesivir) Lyophilized
Powder for Injection
or
Veklury (remdesivir) Injection
200 mg 100 mg
• For patients requiring invasive mechanical ventilation and/or ECMO, total
treatment duration is 10 days.
• For patients not requiring invasive mechanical ventilation and/or ECMO,
total treatment duration is 5 days. If a patient does not demonstrate clinical
improvement, treatment may be extended for up to 5 additional days (i.e.,
up to a total of 10 days).
• Administer Veklury via IV infusion over 30 to 120 minutes (see Full EUA
Prescribing Information, subsection 2.3 Recommended Dosage in
Pediatric Patients).
Pregnancy
Veklury should be used during pregnancy only if the potential benefit justifies the
potential risk for the mother and the fetus.
Renal Impairment
Patients with eGFR greater than or equal to 30 mL/min have received Veklury for
treatment of COVID-19 with no dose adjustment. The safety and efficacy of
Veklury have not been assessed in patients with severe renal impairment or
ESRD. Veklury is not recommended in adult and pediatric patients (greater than
4
28 days old) with eGFR less than 30 mL/min or in full-term neonates (at least 7
days to less than or equal to 28 days old) with serum creatinine greater than or
equal to 1 mg/dL unless the potential benefit outweighs the potential risk.
Adult and pediatric patients (greater than 28 days old) must have an eGFR
determined and full-term neonates (at least 7 days to less than or equal to 28
days old) must have serum creatinine determined before dosing and daily while
receiving Veklury.
Adults
• eGFR, Male: (140 – age in years) × (weight in kg) / 72 × (serum creatinine
in mg/dL);
• eGFR, Female: (140 – age in years) × (weight in kg) × 0.85 / 72 × (serum
creatinine in mg/dL)
Pediatric patients (greater than 28 days old to less than 1 year of age)
• eGFR: 0.45 × (height in cm) / serum creatinine in mg/dL
Pediatric patients (at least 1 year of age to less than 18 years of age)
• eGFR =
0.413 x (height or length)/Scr) if height/length is expressed in centimeters
OR
41.3 x (height or length)/Scr) if height/length is expressed in meters
Hepatic Impairment
It is not known if dosage adjustment is needed in patients with hepatic
impairment, and Veklury should only be used in patients with hepatic impairment
if the potential benefit outweighs the potential risk.
Hepatic laboratory testing should be performed in all patients prior to starting
Veklury and daily while receiving Veklury.

Dose Preparation
Care should be taken during admixture to prevent inadvertent microbial
contamination. As there is no preservative or bacteriostatic agent present in this
product, aseptic technique must be used in preparation of the final parenteral
solution. It is always recommended to administer IV medication immediately after
preparation when possible.
Store diluted Veklury (remdesivir) solution for infusion up to 4 hours at room
temperature (20°C to 25°C [68°F to 77°F]) or 24 hours at refrigerated
temperature (2°C to 8°C [36°F to 46°F]).
5
Important Preparation and Administration Instructions
• There are important differences in the preparation of the lyophilized
powder and the concentrated solution. Refer to the complete preparation,
storage, and administration instructions in the Full EUA Prescribing
Information, subsections 2.7 and 2.8.
• Veklury (remdesivir) for Injection, 100 mg: Reconstitute Veklury for
injection lyophilized powder with 19 mL of Sterile Water for Injection and
further dilute in 0.9% sodium chloride infusion bag prior to administration.
• Veklury (remdesivir) Injection, 100 mg/20 mL (5 mg/mL): Dilute
Veklury injection concentrated solution in 0.9% sodium chloride infusion
bag prior to administration.
• Prepare solution for infusion on same day as administration.
• Administer diluted Veklury as an IV infusion over 30 to 120 minutes.
• After infusion is complete, flush with 0.9% sodium chloride.
• Discard any remaining reconstituted Veklury lyophilized powder,
reconcentrated solution, and diluted solution.
Storage and Handling of Prepared Dosages
IMPORTANT:
This product contains no preservative. Any unused portion of a single-dose
Veklury vial should be discarded after a diluted solution is prepared.
Parenteral drug products 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.
The prepared diluted solution should not be administered simultaneously with
any other medication. The compatibility of Veklury injection with IV solutions and
medications other than 0.9% sodium chloride is not known.
Warnings
There are limited clinical data available for Veklury. Serious and unexpected
adverse events may occur that have not been previously reported with Veklury
use.
Hypersensitivity Including Infusion-Related and Anaphylactic Reactions
Hypersensitivity reactions including infusion-related and anaphylactic reactions
have been observed during and following administration of Veklury (remdesivir).
Signs and symptoms may include hypotension, tachycardia, bradycardia,
dyspnea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and
shivering. Slower infusion rates, with a maximum infusion time of up to 120
6
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 Veklury and initiate appropriate
treatment. The use of Veklury is contraindicated in patients with known
hypersensitivity to remdesivir [see Full EUA Prescribing Information,
Contraindications (4)].
Increased Risk of Transaminase Elevations
Transaminase elevations have been observed in healthy volunteers who
received 200 mg of Veklury followed by 100 mg doses for 5 to10 days.
Transaminase elevations have also been reported in patients with COVID-19
who received Veklury in clinical trials. As transaminase elevations have been
reported as a component of COVID-19, including in patients receiving placebo in
clinical trials of Veklury, discerning the contribution of Veklury to transaminase
elevations in this patient population is challenging.
Hepatic laboratory testing should be performed in all patients prior to starting
Veklury and daily while receiving Veklury.
• Veklury should not be initiated in patients with ALT greater than or equal
to 5 times the upper limit of normal (ULN) at baseline.
• Veklury should be discontinued in patients who develop:
o ALT greater than or equal to 5 times the ULN during treatment with
Veklury. Veklury may be restarted when ALT is less than 5 times
the ULN.
OR
o ALT elevation accompanied by signs or symptoms of liver
inflammation or increasing conjugated bilirubin, alkaline
phosphatase, or INR.
Risk of Reduced Antiviral Activity When Coadministered with Chloroquine or
Hydroxychloroquine
Coadministration of Veklury and chloroquine phosphate or hydroxychloroquine
sulfate is not recommended based on in vitro data demonstrating an
antagonistic effect of chloroquine on the intracellular metabolic activation and
antiviral activity of Veklury [see Full EUA Prescribing Information, Drug
interactions (10), Microbiology/resistance information (15)].
Serious Side Effects
An adverse reaction associated with Veklury (remdesivir) in clinical trials in
healthy adult subjects was increased liver transaminases. Additional adverse
reactions associated with the drug, some of which may be serious, may become
apparent with more widespread use.
7
INSTRUCTIONS FOR HEALTH CARE PROVIDERS
As the health care provider, you must communicate to your patient or
parent/caregiver information consistent with the “Fact Sheet for Patients and
Parents/Caregivers” (and provide a copy of the Fact Sheet) prior to the patient
receiving Veklury, including:
• FDA has authorized the emergency use of Veklury (remdesivir), which is
not an FDA approved drug.
• The patient or parent/caregiver has the option to accept or refuse Veklury.
• The significant known and potential risks and benefits of Veklury, and the
extent to which such risks and benefits are unknown.
• Information on available alternative treatments and the risks and benefits
of those alternatives.
If providing this information will delay the administration of Veklury to a degree
that would endanger the lives of patients, the information must be provided to the
patients as soon as practicable after Veklury is administered.
For information on clinical trials that are testing the use of Veklury for COVID-19,
please see www.clinicaltrials.gov.
MANDATORY REQUIREMENTS FOR VEKLURY (REMDESIVIR)
ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION:
In order to mitigate the risks of using this unapproved product under EUA and to
optimize the potential benefit of Veklury, the following items are required. Use of
unapproved Veklury (remdesivir) under this EUA is limited to the following (all
requirements must be met):

  1. Treatment of suspected or laboratory confirmed coronavirus disease 2019
    (COVID-19) in adults and pediatric patients hospitalized with severe
    disease. Severe disease is defined as patients with an oxygen saturation
    (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring
    invasive mechanical ventilation, or requiring ECMO. Specifically, Veklury
    is authorized only for the following patients who are admitted to a hospital
    and under the care or consultation of a licensed clinician (skilled in the
    diagnosis and management of patients with potentially life-threatening
    illness and the ability to recognize and manage medication-related
    adverse events):
    a. Adult patients for whom use of an IV agent is clinically appropriate.
    b. Pediatric patients for whom use of an IV agent is clinically
    appropriate.
  2. As the health care provider, communicate to your patient or
    parent/caregiver information consistent with the “Fact Sheet for Patients
    and Parents/Caregivers” prior to the patient receiving Veklury. Health care
    providers (to the extent practicable given the circumstances of the
    8
    emergency) must document in the patient’s medical record that the
    patient/caregiver has been:
    a. Given the Fact Sheet for Patients and Parents/Caregivers,
    b. Informed of alternatives to receiving Veklury, and
    c. Informed that Veklury is an unapproved drug that is authorized for
    use under EUA.
  3. Adult and pediatric patients (greater than 28 days old) must have an
    eGFR determined and full-term neonates (at least 7 days to less than or
    equal to 28 days old) must have serum creatinine determined prior to
    Veklury first administration and daily while receiving Veklury.
  4. Hepatic laboratory testing should be performed in all patients prior to
    starting Veklury and daily while receiving Veklury.
  5. Patients with known hypersensitivity to any ingredient of Veklury must not
    receive Veklury.
  6. The prescribing health care provider and/or the provider’s designee are/is
    responsible for mandatory responses to requests from FDA for information
    about adverse events and medication errors following receipt of Veklury.
  7. The prescribing health care provider and/or the provider’s designee are/is
    responsible for mandatory reporting of all medication errors and adverse
    events (death, serious adverse events*) considered to be potentially
    related to Veklury occurring during Veklury treatment within 7 calendar
    days from the onset of the event. The reports should include unique
    identifiers and the words “Veklury (remdesivir) under Emergency Use
    Authorization (EUA)” in the description section of the report.
    • Submit adverse event reports to FDA MedWatch using one of the
    following methods:
    ▪ Complete and submit the report online:
    www.fda.gov/medwatch/report.htm, or
    ▪ By using a postage-paid Form FDA 3500 (available at
    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForm
    s/Forms/UCM163919.pdf) and returning by mail (MedWatch,
    5600 Fishers Lane, Rockville, MD 20852-9787), or by fax (1-
    800-FDA-0178), or
    ▪ Call 1-800-FDA-1088 to request a reporting form
    ▪ Submitted reports should include in the field name, “Describe
    Event, Problem, or Product Use/Medication Error” a statement
    “Veklury (remdesivir) under Emergency Use Authorization
    (EUA).”
    *Serious Adverse Events are defined as:
    • death;
    • a life-threatening adverse event;
    • inpatient hospitalization or prolongation of existing hospitalization;
    • a persistent or significant incapacity or substantial disruption of the
    ability to conduct normal life functions;
    9
    • a congenital anomaly/birth defect;
    • a medical or surgical intervention to prevent death, a life-threatening
    event, hospitalization, disability, or congenital anomaly.
    [see Adverse Reactions and Medication Errors Reporting Requirements and
    Instructions (8)]
    OTHER REPORTING REQUIREMENTS
    In addition please provide a copy of all FDA MedWatch forms to:
    Gilead Pharmacovigilance and Epidemiology
    Fax: 1-650-522-5477
    E-mail: Safety_fc@gilead.com
    APPROVED AVAILABLE ALTERNATIVES
    There is no approved available alternative product. There are EUAs for other
    COVID-19 treatments. Additional information on COVID-19 treatments can be
    found at https://www.covid19treatmentguidelines.nih.gov/. The health care
    provider should visit https://clinicaltrials.gov/ to determine whether the patient
    may be eligible for enrollment in a clinical trial.
    AUTHORITY FOR ISSUANCE OF THE EUA
    The Secretary of HHS has declared a public health emergency that justifies the
    emergency use of Veklury (remdesivir) to treat COVID-19 caused by SARS-CoV2. In response, the FDA has issued an EUA for the unapproved product, Veklury,
    for the treatment of COVID-19.
    1 As a health care provider, you must comply with
    the mandatory requirements of the EUA (see below).
    FDA issued this EUA, requested by Gilead Sciences, Inc. and based on their
    submitted data.
    Although limited scientific information is available, based on the totality of the
    scientific evidence available to date, it is reasonable to believe that Veklury may
    be effective for the treatment of COVID-19 in patients as specified in this Fact
    Sheet. You may be contacted and asked to provide information to help with the
    assessment of the use of the product during this emergency.
    This EUA for Veklury will end when the Secretary determines that the
    circumstances justifying the EUA no longer exist or when there is a change in the
    approval status of the product such that an EUA is no longer needed.

1 The health care provider should visit clinicaltrials.gov to determine whether there is an active
clinical trial for the product in this disease/condition and whether enrollment of the patient(s) in a
clinical trial is more appropriate than product use under this EUA.
10
FULL EUA PRESCRIBING INFORMATION
FULL EUA PRESCRIBING INFORMATION:
CONTENTS*
1 AUTHORIZED USE
2 DOSAGE AND ADMINISTRATION
2.1 Important Testing Prior to and During
Treatment and Route of Administration
2.2 Recommended Dosage in Adult Patients
2.3 Recommended Dosage in Pediatric Patients
2.4 Pregnancy
2.5 Renal Impairment
2.6 Hepatic Impairment
2.7 Dose Preparation and Administration, Adults
and Pediatric Patients Weighing 40 kg and
Higher
2.8 Dose Preparation and Administration, Pediatric
Patients Weighing 3.5 kg to Less Than 40 kg
2.9 Storage of Prepared Dosages
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Including Infusion-Related and
Anaphylactic Reactions
5.2 Increased Risk of Transaminase Elevations
5.3 Risk of Reduced Antiviral Activity When
Coadministered with Chloroquine or
Hydroxychloroquine
6 OVERALL SAFETY SUMMARY
6.1 Clinical Trials Experience
6.2 Hepatic Adverse Reactions
7 PATIENT MONITORING RECOMMENDATIONS
8 ADVERSE REACTIONS AND MEDICATION
ERRORS REPORTING REQUIREMENTS AND
INSTRUCTIONS
9 OTHER REPORTING REQUIREMENTS
10 DRUG INTERACTIONS
11 USE IN SPECIFIC POPULATIONS
11.1 Pregnancy
11.2 Nursing Mothers
11.3 Pediatric Use
11.4 Geriatric Use
11.5 Renal Impairment
11.6 Hepatic Impairment
12 OVERDOSAGE
13 PRODUCT DESCRIPTION
13.1 Physical Appearance
13.2 Inactive Ingredients
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
14.2 Pharmacokinetics
15 MICROBIOLOGY/RESISTANCE INFORMATION
16 NONCLINICAL TOXICOLOGY
17 ANIMAL PHARMACOLOGIC AND EFFICACY
DATA
18 CLINICAL TRIAL RESULTS AND SUPPORTING
DATA FOR EUA
19 HOW SUPPLIED/STORAGE AND HANDLING
20 PATIENT COUNSELING INFORMATION
21 CONTACT INFORMATION
*Sections or subsections omitted from the full
prescribing information are not listed.

  1. AUTHORIZED USE
    Veklury (remdesivir) is authorized for use under an EUA for treatment of patients
    hospitalized with suspected or laboratory confirmed SARS-CoV-2 infection and
    severe disease. Severe disease is defined as patients with an oxygen saturation
    (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring
    mechanical ventilation or requiring extracorporeal membrane oxygenation
    (ECMO). Specifically, Veklury is only authorized for hospitalized adult and
    pediatric patients for whom use of an intravenous (IV) agent is clinically
    appropriate.
  2. DOSAGE AND ADMINISTRATION
    2.1 Important Testing Prior to and During Treatment and Route of
    Administration
    • Adult and pediatric patients (greater than 28 days old) must have an
    eGFR determined and full-term neonates (at least 7 days to less than or
    equal to 28 days old) must have serum creatinine determined before
    dosing of Veklury and daily while receiving Veklury [see Dosage and
    Administration (2.5), Use in Specific Populations (11.5)].
    • Hepatic laboratory testing should be performed in all patients prior to
    starting Veklury and daily while receiving Veklury [see Dosage and
    11
    Administration (2.6), Warnings and Precautions (5.2), Use in Specific
    Populations (11.6)].
    • Veklury (remdesivir) should be administered via IV infusion only. Do not
    administer as an intramuscular (IM) injection.
    2.2 Recommended Dosage in Adult Patients
    • The recommended dosage in adults is a single loading dose of Veklury
    200 mg on Day 1 followed by once-daily maintenance doses of Veklury
    100 mg from Day 2 via IV infusion.
    • For patients requiring invasive mechanical ventilation and/or ECMO, total
    treatment duration is 10 days.
    • For patients not requiring invasive mechanical ventilation and/or ECMO,
    total treatment duration is 5 days. If a patient does not demonstrate clinical
    improvement, treatment may be extended for up to 5 additional days (i.e.,
    up to a total of 10 days).
    • Administer Veklury via IV infusion in a total volume of up to 250 mL 0.9%
    sodium chloride over 30 to 120 minutes [see Dosage and Administration
    (2.7)].
    2.3 Recommended Dosage in Pediatric Patients
    For pediatric patients weighing 3.5 kg to less than 40 kg, the dose should be
    calculated using the mg/kg dose according to the patient’s weight [see Dosage
    and Administration (2.8), Use in Specific Populations (11.3)]:
    • For pediatric patients weighing 3.5 kg to less than 40 kg, use Veklury
    (remdesivir) for injection, 100 mg, lyophilized powder only. Do not
    use Veklury injection, 100 mg/20 mL (5 mg/mL), for pediatric patients
    weighing 3.5 kg to less than 40 kg due to the higher amount of SBECD
    present and resulting higher tonicity of the solution concentrate compared
    to the lyophilized formulation.
    • Refer to Table 1 below for recommended dosage form and dosage in
    pediatric patients according to weight.
    Table 1: Recommended Dosage Form and Dosage in Pediatric Patients
    Body weight Recommended dosage form
    Loading
    dose
    (on Day 1)
    Maintenance
    dose
    (from Day 2)
    3.5 kg to
    less than 40 kg
    Veklury (remdesivir) Lyophilized
    Powder for Injection Only 5 mg/kg 2.5 mg/kg
    40 kg and
    higher
    Veklury (remdesivir) Lyophilized
    Powder for Injection
    or
    Veklury (remdesivir) Injection
    200 mg 100 mg
    12
    • For pediatric patients requiring invasive mechanical ventilation and/or
    ECMO, total treatment duration is 10 days.
    • For pediatric patients not requiring invasive mechanical ventilation and/or
    ECMO, total treatment duration Is 5 days. If a patient does not
    demonstrate clinical improvement, treatment may be extended for up to 5
    additional days (i.e., up to a total of 10 days).
    2.4 Pregnancy
    Veklury (remdesivir) should be used during pregnancy only if the potential benefit
    justifies the potential risk for the mother and the fetus.
    2.5 Renal Impairment
    Adult and pediatric patients (greater than 28 days old) must have an eGFR
    determined and full-term neonates (at least 7 days to less than or equal to 28
    days old) must have serum creatinine determined before dosing and daily while
    receiving Veklury [see Use in Specific Populations (11.5)].
    Adults
    • eGFR, Male: (140 – age in years) × (weight in kg) / 72 × (serum creatinine
    in mg/dL);
    • eGFR, Female: (140 – age in years) × (weight in kg) × 0.85 / 72 × (serum
    creatinine in mg/dL)
    Pediatric patients (greater than 28 days old to less than 1 year of age)
    • eGFR: 0.45 × (height in cm) / serum creatinine in mg/dL
    Pediatric patients (at least 1 year of age to less than 18 years of age)
    • eGFR =
    0.413 x (height or length)/Scr) if height/length is expressed in centimeters
    OR
    41.3 x (height or length)/Scr) if height/length is expressed in meters
    Because the excipient SBECD is renally cleared and accumulates in patients
    with decreased renal function, administration of drugs formulated with SBECD
    (such as Veklury) is not recommended in adults and pediatric patients (greater
    than 28 days old) with eGFR less than 30 mL/min or in full-term neonates (at
    least 7 days and less than or equal to 28 days old) with serum creatinine greater
    than or equal to 1 mg/dL unless the potential benefit outweighs the potential risk.
    2.6 Hepatic Impairment
    It is not known if dosage adjustment is needed in patients with hepatic
    impairment, and Veklury should only be used in patients with hepatic impairment
    if the potential benefit outweighs the potential risk [see Warnings and
    Precautions (5.2), Use in Specific Populations (11.6)].
    13
    Hepatic laboratory testing should be performed in all patients prior to starting
    Veklury and daily while receiving Veklury.
    2.7 Dose Preparation and Administration, Adults and Pediatric Patients
    Weighing 40 kg and Higher
    Adults and pediatric patients weighing 40 kg and higher can use Veklury for
    injection, 100 mg, lyophilized powder and Veklury injection, 100 mg/20 mL (5
    mg/mL), solution. See below for different preparation and administration
    instructions for the two dosage formulations.
    Veklury (remdesivir) for Injection, 100 mg, Lyophilized Powder
    Reconstitution Instructions
    Remove the required number of single-dose vial(s) from storage. For each vial:
    • Aseptically reconstitute Veklury lyophilized powder by addition of 19 mL of
    Sterile Water for Injection using a suitably sized syringe and needle per
    vial.
    • Discard the vial if a vacuum does not pull the Sterile Water for Injection
    into the vial.
    • Immediately shake the vial for 30 seconds.
    • Allow the contents of the vial to settle for 2 to 3 minutes. A clear 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.
    • Following reconstitution, each vial contains 100 mg/20 mL (5 mg/mL) of
    remdesivir solution.
    • Parenteral drug products should be inspected visually for particulate
    matter and discoloration prior to administration, whenever solution and
    container permit.
    • After reconstitution, the total storage time before administration should not
    exceed 4 hours at room temperature or 24 hours at refrigerated
    temperature (2°C to 8°C [36°F to 46°F]).
    Dilution Instructions
    Care should be taken during admixture to prevent inadvertent microbial
    contamination. As there is no preservative or bacteriostatic agent present in this
    product, aseptic technique must be used in preparation of the final parenteral
    solution. It is always recommended to administer IV medication immediately after
    preparation when possible.
    • The reconstituted Veklury lyophilized powder for injection, containing 100
    mg/20 mL remdesivir solution, should be further diluted in 100 mL or 250
    mL 0.9% sodium chloride infusion bags.
    • Using Table 2, determine the volume of 0.9% sodium chloride to withdraw
    from the infusion bag.
    14
    Table 2: Recommended Dilution Instructions Using Reconstituted
    Veklury (remdesivir) for Injection Lyophilized Powder in Adults
    and Pediatric Patients Weighing 40 kg and Higher
    Veklury
    dose
    0.9% sodium
    chloride infusion
    bag volume to be
    used
    Volume to be
    withdrawn and
    discarded from
    0.9% sodium
    chloride infusion
    bag
    Required volume
    of reconstituted
    Veklury for
    injection
    200 mg
    (2 vials)
    250 mL 40 mL 40 mL (2  20 mL)
    100 mL 40 mL 40 mL (2  20 mL)
    100 mg
    (1 vial)
    250 mL 20 mL 20 mL
    100 mL 20 mL 20 mL
    • Withdraw and discard the required volume of 0.9% sodium chloride from
    the bag per Table 2 using an appropriately sized syringe and needle.
    • Withdraw the required volume of reconstituted Veklury for injection from
    the Veklury vial using an appropriately sized syringe per Table 2. Discard
    any unused portion remaining in the Veklury vial.
    • Transfer the required volume of reconstituted Veklury for injection to the
    selected infusion bag.
    • Gently invert the bag 20 times to mix the solution in the bag. Do not
    shake.
    • The prepared diluted solution is stable for 4 hours at room temperature
    (20°C to 25°C [68°F to 77°F]) or 24 hours in the refrigerator at 2°C to 8°C
    (36°F to 46°F).
    Administration Instructions
    The prepared diluted solution should not be administered simultaneously with
    any other IV medication. The compatibility of Veklury injection with IV solutions
    and medications other than 0.9% sodium chloride is not known.
    Administer the diluted solution with the infusion rate described in Table 3.
    15
    Table 3: Recommended Rate of Infusion — Diluted Veklury (remdesivir)
    for Injection Lyophilized Powder in Adults and Pediatric
    Patients Weighing 40 kg and Higher
    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
    Veklury (remdesivir) Injection, 100 mg/20 mL (5 mg/mL), Solution
    Dilution Instructions
    Care should be taken during admixture to prevent inadvertent microbial
    contamination. As there is no preservative or bacteriostatic agent present in this
    product, aseptic technique must be used in preparation of the final parenteral
    solution. It is always recommended to administer IV medication immediately after
    preparation when possible.
    • Remove the required number of single-dose vial(s) from storage. Each vial
    contains 100 mg of remdesivir. For each vial:
    • Equilibrate to room temperature (20°C to 25°C [68°F to 77°F]).
    Sealed vials can be stored up to 12 hours at room temperature
    prior to dilution.
    • Inspect the vial to ensure the container closure is free from defects
    and the solution is free of particulate matter.
    • Using Table 4, determine the volume of 0.9% sodium chloride to withdraw
    from the infusion bag.
    16
    Table 4: Recommended Dilution Instructions— Veklury (remdesivir)
    Solution in Adults and Pediatric Patients Weighing 40 kg and
    Higher
    Veklury
    dose
    0.9% sodium
    chloride infusion
    bag volume to be
    used
    Volume to be
    withdrawn and
    discarded from
    0.9% sodium
    chloride infusion
    bag
    Required volume
    of Veklury injection
    solution
    200 mg
    (2 vials)
    250 mL
    40 mL 40 mL (2  20 mL)
    100 mg
    (1 vial) 20 mL 20 mL
    • Withdraw and discard the required volume of 0.9% sodium chloride from
    the bag per Table 4 using an appropriately sized syringe and needle.
    • Withdraw the required volume of Veklury injection solution from the
    Veklury 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 Veklury injection vial above the level of the
    solution.
    • Invert the vial and withdraw the required volume of Veklury injection
    solution into the syringe. The last 5 mL of solution requires more
    force to withdraw.
    • Discard any unused solution remaining in the Veklury vial.
    • Transfer the required volume of Veklury injection solution to the infusion
    bag.
    • Gently invert the bag 20 times to mix the solution in the bag. Do not
    shake.
    • The prepared diluted solution is stable for 4 hours at room temperature
    (20°C to 25°C [68°F to 77°F]) or 24 hours in the refrigerator at 2°C to 8°C
    (36°F to 46°F).
    Administration Instructions
    The prepared diluted solution should not be administered simultaneously with
    any other medication. The compatibility of Veklury injection with IV solutions and
    medications other than 0.9% sodium chloride is not known.
    Administer the diluted solution with the infusion rate described in Table 5.
    17
    Table 5: Recommended Rate of Infusion—Diluted Veklury (remdesivir)
    Solution in Adults and Pediatric Patients Weighing 40 kg and
    Higher
    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
    2.8 Dose Preparation and Administration, Pediatric Patients Weighing
    3.5 kg to Less Than 40 kg
    For pediatric patients weighing 3.5 kg to less than 40 kg, use Veklury
    (remdesivir) for injection, 100 mg, lyophilized powder only. Veklury injection,
    100 mg/20 mL (5 mg/mL), should not be used for pediatric patients weighing 3.5
    kg to less than 40 kg due to the higher amount of SBECD present and resulting
    higher tonicity of the solution concentrate compared to the lyophilized
    formulation.
    Veklury (remdesivir) for Injection, 100 mg, Lyophilized Powder
    Reconstitution Instructions
    Remove the required number of single-dose vial(s) from storage. For each vial:
    • Aseptically reconstitute Veklury lyophilized powder by addition of 19 mL of
    Sterile Water for Injection using a suitably sized syringe and needle per
    vial.
    • Discard the vial if a vacuum does not pull the Sterile Water for
    Injection into the vial.
    • Immediately shake the vial for 30 seconds.
    • Allow the contents of the vial to settle for 2 to 3 minutes. A clear 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.
    • Following reconstitution, each vial contains 100 mg/20 mL (5 mg/mL) of
    remdesivir solution.
    • Parenteral drug products should be inspected visually for particulate
    matter and discoloration prior to administration, whenever solution and
    container permit.
    • After reconstitution, the total storage time before administration should not
    exceed 4 hours at room temperature or 24 hours at refrigerated
    temperature (2°C to 8°C [36°F to 46°F]).
    18
    Dilution Instructions
    • Care should be taken during admixture to prevent inadvertent
    microbial contamination. As there is no preservative or bacteriostatic
    agent present in this product, aseptic technique must be used in
    preparation of the final parenteral solution. It is always recommended to
    administer IV medication immediately after preparation when possible.
    Following reconstitution as instructed above, each vial will contain a 100
    mg/20 mL (5 mg/mL) remdesivir concentrated solution. For pediatric
    patients weighing 3.5 kg to less than 40 kg, the 100 mg/20 mL (5 mg/mL)
    remdesivir concentrate should be further diluted to a fixed concentration of
    1.25 mg/mL using 0.9% sodium chloride.
    • The total required infusion volume of the 1.25 mg/mL remdesivir solution
    for infusion is calculated from the pediatric weight-based dosing regimens
    of 5 mg/kg for the Loading Dose and 2.5 mg/kg for each Maintenance
    Dose.
    • Small 0.9% sodium chloride infusion bags (e.g., 25, 50, or 100 mL) or an
    appropriately sized syringe should be used for pediatric dosing. The
    recommended dose is administered via IV infusion in a total volume
    dependent on the dose to yield the target remdesivir concentration of
    1.25 mg/mL.
    • A syringe may be used for delivering volumes less than 50 mL.
    Infusion with IV Bag
    • Prepare an IV bag of 0.9% sodium chloride with volume equal to the total
    infusion volume minus the volume of reconstituted remdesivir solution that
    will be diluted to achieve a 1.25 mg/mL solution.
    • Withdraw the required volume of reconstituted solution containing
    remdesivir for injection into an appropriately sized syringe.
    • Transfer the required volume of reconstituted remdesivir for injection to
    the 0.9% sodium chloride infusion bag.
    • Gently invert the bag 20 times to mix the solution in the bag. Do not
    shake.
    Infusion with Syringe
    • Select an appropriately sized syringe equal to or larger than the calculated
    total infusion volume of 1.25 mg/mL remdesivir solution needed.
    • Withdraw the required volume of 100 mg/20 mL (5 mg/mL) reconstituted
    remdesivir solution from the vial into the syringe followed by the required
    volume of 0.9% sodium chloride needed to achieve a 1.25 mg/mL
    remdesivir solution.
    • Mix the syringe by inversion 20 times.
    • The prepared diluted solution is stable for 4 hours at room temperature
    (20°C to 25°C [68°F to 77°F]) or 24 hours in the refrigerator at 2°C to 8°C
    (36°F to 46°F) (including any time before dilution into intravenous infusion
    fluids).
    19
    Administration Instructions
    The prepared diluted solution should not be administered simultaneously with
    any other medication. The compatibility of Veklury (remdesivir) injection with IV
    solutions and medications other than 0.9% sodium chloride is not known.
    Administer the diluted solution with the infusion rate described in Table 6.
    Table 6: Recommended Rate of Infusion—Diluted Veklury (remdesivir)
    for Injection Lyophilized Powder for Pediatric Patients
    Weighing 3.5 kg to Less Than 40 kg
    Infusion bag volume Infusion time Rate of infusiona
    100 mL
    30 min 3.33 mL/min
    60 min 1.67 mL/min
    120 min 0.83 mL/min
    50 mL
    30 min 1.67 mL/min
    60 min 0.83 mL/min
    120 min 0.42 mL/min
    25 mL
    30 min 0.83 mL/min
    60 min 0.42 mL/min
    120 min 0.21 mL/min
    a. Note: Rate of infusion may be adjusted based on total volume to be infused.
    2.9 Storage of Prepared Dosages
    Lyophilized Powder
    After reconstitution, vials can be stored up to 4 hours at room temperature (20°C
    to 25°C [68°F to 77°F]) prior to administration or 24 hours at refrigerated
    temperature (2°C to 8°C [36°F to 46°F]). Dilute within the same day as
    administration.
    Injection Solution
    Prior to dilution, equilibrate Veklury injection to room temperature (20°C to 25°C
    [68°F to 77°F]). Sealed vials can be stored up to 12 hours at room temperature
    prior to dilution.
    Diluted Infusion Solution
    Store diluted Veklury solution for infusion up to 4 hours at room temperature
    (20°C to 25°C [68°F to 77°F]) or 24 hours at refrigerated temperature (2°C to 8°C
    [36°F to 46°F]).
    20
    IMPORTANT:
    This product contains no preservative. Any unused portion of a single-dose
    Veklury vial should be discarded after a diluted solution is prepared. Maintain
    adequate records showing receipt, use, and disposition of Veklury. For unused
    intact vials, maintain adequate records showing disposition of Veklury; do not
    discard unused intact vials.
  3. DOSAGE FORMS AND STRENGTHS
    • Veklury (remdesivir) for injection, 100 mg: Each single-dose vial of Veklury for
    injection,100 mg, contains a sterile, preservative-free white to off-white to
    yellow lyophilized powder that is to be reconstituted with 19 mL of Sterile
    Water for Injection and further diluted into 0.9% sodium chloride infusion bag
    prior to administration by intravenous infusion. Following reconstitution, each
    vial contains 100 mg/20 mL (5 mg/mL) remdesivir reconcentrated solution.
    • Veklury (remdesivir) injection, 100 mg/20 mL (5 mg/mL): Each single-dose
    vial of Veklury injection contains 100 mg/20 mL (5 mg/mL) of remdesivir as a
    clear, colorless to yellow, aqueous-based concentrated solution that is to be
    diluted into 0.9% sodium chloride infusion bag prior to administration by
    intravenous infusion.
  4. CONTRAINDICATIONS
    Veklury is contraindicated in patients with known hypersensitivity to any
    ingredient of Veklury [see Product Description (13)].
  5. WARNINGS AND PRECAUTIONS
    There are limited clinical data available for Veklury. Serious and unexpected
    adverse events may occur that have not been previously reported with Veklury
    use.
    5.1 Hypersensitivity Including Infusion-Related and Anaphylactic
    Reactions
    Hypersensitivity reactions including infusion-related and anaphylactic reactions
    have been observed during and following administration of Veklury. Signs and
    symptoms may include hypotension, tachycardia