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Remdesivir

Class: Nucleosides and Nucleotides
Chemical Name: 2-Ethylbutyl N-{(S)-[2-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,5-anhydro-d-altrononitril-6-O-yl] phenoxyphosphoryl}-L-alaninate
Molecular Formula: C27H35N6O8P
CAS Number: 1809249-37-3

Medically reviewed by Drugs.com on April 19, 2021. Written by ASHP.

Introduction

Antiviral; nucleoside RNA polymerase inhibitor.

Uses for Remdesivir

Coronavirus Disease 2019 (COVID-19)

Treatment of COVID-19 caused by SARS-CoV-2 in adults and pediatric patients ≥12 years of age weighing ≥40 kg who are hospitalized or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Safety and efficacy not established in pediatric patients <12 years of age or weighing <40 kg. Available under an emergency use authorization (EUA) for treatment of suspected or laboratory-confirmed COVID-19 in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg who are hospitalized or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

There is evidence from clinical trials that remdesivir treatment is associated with some benefits (e.g., shorter time to clinical improvement and/or recovery) in hospitalized adults with COVID-19; the benefit appears to be most apparent in those who require supplemental oxygen but do not require high-flow oxygen, noninvasive or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at baseline. Multiple trials are ongoing to evaluate efficacy and safety when used alone or in conjunction with other therapeutic agents for treatment of COVID-19. Safety and efficacy for prevention of COVID-19 not established.

Based on clinical trial data available to date, NIH COVID-19 Treatment Guidelines Panel issued guidelines regarding use of remdesivir (with or without dexamethasone) for management of COVID-19 based on disease severity. For hospitalized patients requiring supplemental oxygen but not requiring high-flow oxygen, noninvasive ventilation, invasive mechanical ventilation, or ECMO, the NIH panel recommends remdesivir (e.g., for those requiring minimal supplemental oxygen) or remdesivir and dexamethasone (e.g., for those requiring increasing amounts of supplemental oxygen) or dexamethasone alone (e.g., when remdesivir is unavailable or cannot be used). For hospitalized patients requiring high-flow oxygen or noninvasive ventilation, the panel recommends dexamethasone alone or dexamethasone and remdesivir; the panel recommends against remdesivir alone because of uncertainty regarding benefit of the drug in such patients. For hospitalized patients requiring invasive mechanical ventilation or ECMO, the panel recommends dexamethasone; may consider dexamethasone and remdesivir for patients who were recently intubated. If dexamethasone indicated and not available, other corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone) can be used.

NIH panel states that data insufficient to date to recommend either for or against use of remdesivir in outpatients or in hospitalized patients with moderate COVID-19 not requiring supplemental oxygen; however, there may be situations when the drug is appropriate for hospitalized patients with moderate disease (e.g., those at particularly high risk for clinical deterioration).

Consult the most recent NIH COVID-19 treatment guidelines for additional information.

IDSA suggests the use of remdesivir over no antiviral treatment in hospitalized patients with severe COVID-19 (i.e., peripheral oxygen saturation [SpO2] <94% on room air or requiring supplemental oxygen, mechanical ventilation, or ECMO). In settings with limited remdesivir supply, consider that the drug appears to be most beneficial in patients with severe COVID-19 who are on supplemental oxygen rather than those on mechanical ventilation or ECMO. These experts suggest against routine use of remdesivir for treatment of COVID-19 in hospitalized patients who do not need supplemental oxygen and have SpO2 >94% on room air.

On May 1, 2020, FDA issued an EUA that permitted use of remdesivir for treatment of COVID-19 in hospitalized adults and pediatric patients with suspected or laboratory-confirmed COVID-19 and severe disease (defined as SpO2 ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, or ECMO); the EUA was broadened on August 28, 2020 to allow treatment of hospitalized adults and pediatric patients with suspected or laboratory-confirmed COVID-19 irrespective of disease severity and was reissued on October 16, 2020 to clarify that alternative care sites meeting certain criteria were considered inpatient hospital settings and within the scope of the EUA. After the drug received full FDA approval on October 22, 2020 for treatment of COVID-19 in adults and pediatric patients ≥12 years of age weighing ≥40 kg, the EUA was reissued again to allow continued authorization (lyophilized powder formulation only) for use in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg. The EUA requires that the drug be administered by a healthcare provider in an inpatient hospital setting (or alternative care site capable of providing acute care comparable to general inpatient hospital care) via IV infusion using the dosages recommended in the EUA.

FDA concluded that emergency use of remdesivir for treatment of COVID-19 met criteria for reissuance for the following reasons: SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness; based on the totality of scientific evidence available to FDA, it is reasonable to believe that the drug may be effective in treating suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg and, when used under EUA conditions, known and potential benefits outweigh known and potential risks; and there are no adequate, approved, and available alternatives to emergency use of remdesivir for treatment of COVID-19 in such pediatric patients. The EUA for remdesivir will end when circumstances justifying the EUA no longer exist or when there is a change in approval status of the drug such that an EUA is no longer needed.

To mitigate risks of the drug, the EUA includes certain mandatory requirements (including providing information to the patient or parent/caregiver and ensuring that all medication errors and serious adverse events are reported to FDA). Consult the EUA letter of authorization ([Web]), EUA fact sheet for healthcare providers ([Web]), and EUA fact sheet for parents and caregivers ([Web]) for additional information.

Remdesivir Dosage and Administration

General

  • Remdesivir is labeled by FDA for treatment of COVID-19 in adults and pediatric patients ≥12 years of age weighing ≥40 kg.

    For treatment of suspected or laboratory-confirmed COVID-19 in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg, the drug is available under an EUA. (See Coronavirus Disease 2019 [COVID-19] under Uses.)

  • Administer only in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. FDA states that such alternative care sites may include temporary facilities intended to provide additional hospital surge capacity and capabilities for communities overwhelmed by patients with COVID-19 or at-home care provided by hospitals that have received waiver approval from US Centers for Medicare and Medicaid Services (CMS) as part of CMS’s Acute Hospital Care at Home (AHCaH) program. FDA also states that remdesivir may be used for labeled indication to treat COVID-19 in adults and pediatric patients ≥12 years of age admitted directly to an alternative care site or to complete the treatment course of the drug, if clinically indicated, in patients transferred from a hospital to an alternative care site.

  • Manufacturer alerted healthcare providers that there are variations in remdesivir packaging and labeling (e.g., use of the tradename Veklury, expiration dates) depending on whether the drug was originally manufactured for use under the EUA or for commercial use. FDA states that they do not intend to object to remdesivir supplies that have labels specifying “for use under Emergency Use Authorization” being distributed for appropriate use under the FDA-labeled indication during the first 6 months after the drug received this approval. Direct questions related to carton or vial labeling or expiration dates to the manufacturer at 866-633-4474 or [Web].

  • FDA issued an alert cautioning against compounding remdesivir drug products from bulk remdesivir active pharmaceutical ingredient because of potential risks.

  • Must assess renal function in all patients prior to and as clinically appropriate during remdesivir treatment. Use eGFR in adults and pediatric patients >28 days of age; use Scr in full-term neonates 7–28 days of age. (See Renal Impairment under Cautions.)

  • Assess hepatic function and PT in all patients prior to and as clinically appropriate during remdesivir treatment. (See Hepatic Impairment under Cautions.)

  • When used under the EUA, may initiate remdesivir in hospitalized patients at any time after onset of COVID-19 symptoms and may consider empiric treatment with the drug pending laboratory confirmation of SARS-CoV-2 infection in hospitalized patients with suspected COVID-19.

Administration

Administer only by IV infusion. Do not give by any other route.

Do not administer simultaneously with any other IV drugs.

Compatible with 0.9% sodium chloride injection; compatibility with other IV solutions or drugs not known.

Do not shake remdesivir solutions. Manufacturer states do not use pneumatic tube systems to transport or deliver IV infusion bags containing remdesivir; studies not conducted to assess effects of vigorous shaking or vibration on the drug.

After the IV infusion of remdesivir completed, flush infusion line with sufficient volume of 0.9% sodium chloride to ensure delivery of entire dose.

Discard solution if discolored or contains particulates.

Does not contain preservatives or bacteriostatic agents. Prepare final dilutions of the drug on same day that they are administered and administer immediately after preparation whenever possible. Discard unused lyophilized powder, solution concentrate, or diluted solutions of the drug; do not reuse or save for future use.

IV Infusion

Available in 2 different formulations: lyophilized powder in single-dose vials containing 100 mg of remdesivir and solution concentrate in single-dose vials containing 100 mg/20 mL (5 mg/mL).

May use either the lyophilized powder or the solution concentrate to prepare remdesivir solutions for IV infusion in adults and pediatric patients ≥12 years of age weighing ≥40 kg.

Use only the lyophilized powder (not solution concentrate) to prepare remdesivir solutions for IV infusion in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg.

Preparation of Lyophilized Powder for Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg

Lyophilized powder must be reconstituted and further diluted prior to IV infusion.

Reconstitute single-dose vial containing 100 mg of lyophilized remdesivir by adding 19 mL of sterile water for injection and immediately shaking vial for 30 seconds. Allow vial contents to settle for 2–3 minutes, resulting in a clear solution. If vial contents not completely dissolved, repeat this process as necessary until drug completely dissolves. Discard vial if contents do not dissolve completely.

Reconstituted solution contains 100 mg/20 mL (5 mg/mL). For use in adults and pediatric patients ≥12 years of age weighing ≥40 kg, further dilute in a 100- or 250-mL IV infusion bag containing 0.9% sodium chloride injection prior to IV infusion.

Perform final dilution for IV infusion on the same day that it is administered; whenever possible, administer immediately following final dilution. (See Powder for Injection, for IV Infusion under Stability.)

Prior to transferring required volume of reconstituted remdesivir solution to the IV infusion bag containing 0.9% sodium chloride, withdraw appropriate volume of 0.9% sodium chloride from the IV bag (using an appropriately sized syringe and needle) and discard. (See Table 1.)

After adding appropriate volume of reconstituted remdesivir to the IV bag containing 0.9% sodium chloride, mix by gently inverting bag 20 times; do not shake.

Table 1. Reconstituted Lyophilized Powder: Dilution Instructions for Preparing Loading Dose (200 mg) and Maintenance Doses (100 mg) of Remdesivir for Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg.1

Remdesivir Dose (mg)

Initial Volume of 0.9% Sodium Chloride in IV Infusion Bag (mL)

Volume of 0.9% Sodium Chloride to be Withdrawn from IV Infusion Bag and Discarded (mL)

Volume of Reconstituted Remdesivir to be Transferred into IV Infusion Bag of 0.9% Sodium Chloride (mL)

200 (2 vials containing 100 mg)

250

40

40 (2 × 20)

100

40

40 (2 × 20)

100 (1 vial containing 100 mg)

250

20

20

100

20

20

Preparation of Lyophilized Powder for Pediatric Patients Weighing 3.5 to <40 kg†

Lyophilized powder must be reconstituted and further diluted prior to IV infusion.

Reconstitute single-dose vial containing 100 mg of lyophilized remdesivir by adding 19 mL of sterile water for injection and immediately shaking vial for 30 seconds. Allow vial contents to settle for 2–3 minutes, resulting in a clear solution. If vial contents not completely dissolved, repeat this process as necessary until drug completely dissolves. Discard vial if contents do not dissolve completely.

Reconstituted solution contains 100 mg/20 mL (5 mg/mL). For use in pediatric patients weighing 3.5 to <40 kg, further dilute in 0.9% sodium chloride to a fixed concentration of 1.25 mg/mL prior to IV infusion.

Perform final dilution for IV infusion on the same day that it is administered; whenever possible, administer immediately following final dilution. (See Powder for Injection, for IV Infusion under Stability.)

Calculate total required infusion volume of diluted remdesivir solution containing 1.25 mg/mL based on the pediatric weight-based dosing regimen of 5 mg/kg for loading dose or 2.5 mg/kg for maintenance doses.

Use a small IV infusion bag (e.g., 25, 50, or 100 mL) or an appropriately sized syringe to administer remdesivir solutions in pediatric patients weighing 3.5 to <40 kg; a syringe and syringe pump may be used to deliver volumes <50 mL. Administer recommended dose via IV infusion in a total infusion volume based on the indicated dose and calculated to yield the target remdesivir concentration of 1.25 mg/mL.

Instruction for use of an IV infusion bag: Use an appropriately sized small IV bag (either prefilled with 0.9% sodium chloride or empty). If using prefilled IV bag, withdraw appropriate volume of 0.9% sodium chloride based on patient's dose plus a quantity sufficient to achieve a final 1.25-mg/mL concentration from the bag (using an appropriately sized syringe and needle) and discard; then withdraw required volume of reconstituted remdesivir solution containing 100 mg/20 mL (5 mg/mL) from the vial (using an appropriately sized syringe and needle) and transfer into the IV bag containing 0.9% sodium chloride. If using empty IV bag, withdraw required volume of reconstituted remdesivir solution containing 100 mg/20 mL (5 mg/mL) from the vial (using an appropriately sized syringe and needle) and transfer into the IV bag; then add appropriate volume of 0.9% sodium chloride sufficient to achieve a final concentration of 1.25 mg/mL to the bag. Mix by gently inverting bag 20 times; do not shake.

Instructions for use of a syringe: Select an appropriately sized syringe for administration that is equal to or larger than the calculated total infusion volume of the 1.25-mg/mL remdesivir solution that is required for the dose. Using the administration syringe, withdraw required volume of reconstituted remdesivir solution containing 100 mg/20 mL (5 mg/mL) from the vial into the syringe followed by the required volume of 0.9% sodium chloride needed to achieve a final remdesivir solution containing 1.25 mg/mL. Mix by gently inverting the syringe 20 times; do not shake.

Preparation of Lyophilized Powder for Pediatric Patients <12 Years of Age Weighing ≥40 kg†

Lyophilized powder must be reconstituted and further diluted prior to IV infusion.

Reconstitute single-dose vial containing 100 mg of lyophilized remdesivir by adding 19 mL of sterile water for injection and immediately shaking vial for 30 seconds. Allow vial contents to settle for 2–3 minutes, resulting in a clear solution. If vial contents not completely dissolved, repeat this process as necessary until drug completely dissolves. Discard vial if contents do not dissolve completely.

Reconstituted solution contains 100 mg/20 mL (5 mg/mL). For use in pediatric patients <12 years of age weighing ≥40 kg, further dilute in a 100- or 250-mL IV infusion bag containing 0.9% sodium chloride injection prior to IV infusion.

Perform final dilution for IV infusion on the same day that it is administered; whenever possible, administer immediately following final dilution. (See Powder for Injection, for IV Infusion under Stability.)

Prior to transferring required volume of reconstituted remdesivir solution to the IV infusion bag containing 0.9% sodium chloride, withdraw appropriate volume of 0.9% sodium chloride from the IV bag (using an appropriately sized syringe and needle) and discard. (See Table 2.)

After adding appropriate volume of reconstituted remdesivir to the IV bag containing 0.9% sodium chloride, mix by gently inverting bag 20 times; do not shake.

Table 2. Reconstituted Lyophilized Powder: Dilution Instructions for Preparing Loading Dose (200 mg) and Maintenance Doses (100 mg) of Remdesivir for Pediatric Patients <12 Years of Age Weighing ≥40 kg†.26

Remdesivir Dose (mg)

Initial Volume of 0.9% Sodium Chloride in IV Infusion Bag (mL)

Volume of 0.9% Sodium Chloride to be Withdrawn from IV Infusion Bag and Discarded (mL)

Volume of Reconstituted Remdesivir to be Transferred into IV Infusion Bag of 0.9% Sodium Chloride (mL)

200 (2 vials containing 100 mg)

250

40

40 (2 × 20)

100

40

40 (2 × 20)

100 (1 vial containing 100 mg)

250

20

20

100

20

20

Preparation of Solution Concentrate for Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg

Solution concentrate must be diluted prior to IV infusion.

Remdesivir solution concentrate contains 100 mg/20 mL (5 mg/mL). For use in adults and pediatric patients weighing ≥40 kg, must dilute in a 250-mL IV infusion bag containing 0.9% sodium chloride injection only prior to IV infusion.

Allow vials of the solution concentrate to equilibrate to room temperature prior to dilution. Perform dilution of solution concentrate for IV infusion on the same day that it is administered; whenever possible, administer immediately following dilution. (See Solution Concentrate for Injection, for IV Infusion under Stability.)

Prior to transferring required volume of remdesivir solution concentrate to the IV infusion bag containing 0.9% sodium chloride, withdraw appropriate volume of 0.9% sodium chloride from the IV bag (using an appropriately sized syringe and needle) and discard. (See Table 3.)

After adding appropriate volume of remdesivir solution concentrate to the IV bag containing 0.9% sodium chloride, mix by gently inverting bag 20 times; do not shake.

Table 3. Solution Concentrate: Dilution Instructions for Preparing Loading Dose (200 mg) and Maintenance Doses (100 mg) of Remdesivir for Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg.1

Remdesivir Dose (mg)

Initial Volume of 0.9% Sodium Chloride in IV Infusion Bag (mL)

Volume of 0.9% Sodium Chloride to be Withdrawn from IV Infusion Bag and Discarded (mL)

Volume of Remdesivir Solution Concentrate to be Transferred into IV Infusion Bag of 0.9% Sodium Chloride (mL)

200 (2 vials containing 100 mg/20 mL)

250

40

40 (2 × 20)

100 (1 vial containing 100 mg/20 mL)

250

20

20

Rate of Administration

Administer IV infusions over 30–120 minutes.

Adults and pediatric patients ≥12 years of age weighing ≥40 kg: For recommended IV infusion rate when administering remdesivir prepared using the lyophilized powder or solution concentrate, see Table 4.

Pediatric patients weighing 3.5 to <40 kg: For recommended IV infusion rate when administering remdesivir prepared using the lyophilized powder, see Table 5.

Pediatric patients <12 years of age weighing ≥40 kg: For recommended IV infusion rate when administering remdesivir prepared using the lyophilized powder, see Table 6.

Table 4. Recommended Rate of IV Infusion in Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg.1

Infusion Bag Volume (mL)

Infusion Time (minutes)

Infusion Rate (mL/minute)

250

(prepared using lyophilized powder or solution concentrate)

30

8.33

250

(prepared using lyophilized powder or solution concentrate)

60

4.17

250

(prepared using lyophilized powder or solution concentrate)

120

2.08

100

(prepared using lyophilized powder)

30

3.33

100

(prepared using lyophilized powder)

60

1.67

100

(prepared using lyophilized powder)

120

0.83

Infusion rate may be adjusted based on total volume to be infused.

Table 5. Recommended Rate of IV Infusion in Pediatric Patients Weighing 3.5 to <40 kg†.26

Infusion Volume (mL)

Infusion Time (minutes)

Infusion Rate (mL/minute)

100

30

3.33

100

60

1.67

100

120

0.83

50

30

1.67

50

60

0.83

50

120

0.42

25

30

0.83

25

60

0.42

25

120

0.21

7

30

0.23

7

60

0.12

7

120

0.6

Table 6. Recommended Rate of IV Infusion in Pediatric Patients <12 Years of Age Weighing ≥40 kg†.26

Infusion Bag Volume (mL)

Infusion Time (minutes)

Infusion Rate (mL/minute)

250

30

8.33

250

60

4.17

250

120

2.08

100

30

3.33

100

60

1.67

100

120

0.83

Dosage

Pediatric Patients

Coronavirus Disease 2019 (COVID-19)
Pediatric Patients ≥12 Years of Age Weighing ≥40 kg
IV

May use either remdesivir lyophilized powder or remdesivir solution concentrate. (See Administration under Dosage and Administration.)

Hospitalized, not requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 5 days. If no clinical improvement, may continue at a dosage of 100 mg by IV infusion once daily for up to 5 additional days (i.e., up to a total treatment duration of 10 days).

Hospitalized, requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 10 days.

Pediatric Patients Weighing 3.5 to <40 kg†
IV

Use only the lyophilized powder (not the solution concentrate). (See Administration under Dosage and Administration.)

EUA that permits use in pediatric patients weighing 3.5 to <40 kg (see Coronavirus Disease 2019 [COVID-19] under Uses) states that the following dosage regimens should be used.

Hospitalized, not requiring invasive mechanical ventilation and/or ECMO: Loading dose of 5 mg/kg by IV infusion on day 1, followed by maintenance doses of 2.5 mg/kg by IV infusion once daily starting on day 2. Recommended total treatment duration is 5 days. If no clinical improvement, may continue at a dosage of 2.5 mg/kg by IV infusion once daily for up to 5 additional days (i.e., up to a total treatment duration of 10 days).

Hospitalized, requiring invasive mechanical ventilation and/or ECMO: Loading dose of 5 mg/kg by IV infusion on day 1, followed by maintenance doses of 2.5 mg/kg by IV infusion once daily starting on day 2. Recommended total treatment duration is 10 days.

Pediatric Patients <12 Years of Age Weighing ≥40 kg†
IV

Use only the lyophilized powder (not the solution concentrate). (See Administration under Dosage and Administration.)

EUA that permits use in pediatric patients <12 years of age weighing ≥40 kg (see Coronavirus Disease 2019 [COVID-19] under Uses) states that the following dosage regimens should be used.

Hospitalized, not requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 5 days. If no clinical improvement, may continue at a dosage of 100 mg by IV infusion once daily for up to 5 additional days (i.e., up to a total treatment duration of 10 days).

Hospitalized, requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 10 days.

Adults

Coronavirus Disease 2019 (COVID-19)
IV

May use either remdesivir lyophilized powder or remdesivir solution concentrate. (See Administration under Dosage and Administration.)

Hospitalized, not requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 5 days. If no clinical improvement, may continue at a dosage of 100 mg by IV infusion once daily for up to 5 additional days (i.e., up to a total treatment duration of 10 days).

Hospitalized, requiring invasive mechanical ventilation and/or ECMO: Loading dose of 200 mg by IV infusion on day 1, followed by maintenance doses of 100 mg by IV infusion once daily starting on day 2. Recommended total treatment duration is 10 days.

NIH panel recommends that hospitalized patients who require supplemental oxygen but are not on high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO receive remdesivir for 5 days or until hospital discharge (may complete treatment course if patient is in a healthcare setting capable of providing acute care comparable to inpatient hospital care). The panel states that treatment duration may be extended up to 10 days in patients who have not shown clinical improvement after a 5-day regimen.

Prescribing Limits

Pediatric Patients

Coronavirus Disease 2019 (COVID-19)
IV

Treatment duration up to 10 days.

Adults

Coronavirus Disease 2019 (COVID-19)
IV

Treatment duration up to 10 days.

Special Populations

Hepatic Impairment

Pharmacokinetics not evaluated in patients with hepatic impairment. (See Hepatic Impairment under Cautions.)

Renal Impairment

Patients with eGFR ≥30 mL/minute have received remdesivir for treatment of COVID-19 without dosage adjustment.

Adults and pediatric patients >28 days of age with eGFR <30 mL/minute: Not recommended. (See Renal Impairment under Cautions.)

Full-term neonates 7–28 days of age with Scr ≥1 mg/dL: Not recommended. (See Renal Impairment under Cautions.)

Geriatric Patients

Dosage adjustment not needed. Consider greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly. (See Geriatric Use under Cautions.)

Cautions for Remdesivir

Contraindications

  • History of clinically important hypersensitivity reactions to the drug or any ingredient in the formulation.

Warnings/Precautions

Hypersensitivity and Infusion-related Reactions

Hypersensitivity reactions, including infusion-related and anaphylactic reactions, observed during and following remdesivir administration. Signs and symptoms of such reactions may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Consider a slower rate of IV infusion, with a maximum infusion time of up to 120 minutes, to potentially prevent these signs and symptoms.

Monitor for hypersensitivity reactions under close medical supervision during and following administration. If signs and symptoms of a clinically important hypersensitivity reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment.

Increased Risk of Aminotransferase Elevations

Aminotransferase elevations observed in healthy individuals who received remdesivir in phase 1 studies and also reported in patients with COVID-19 who received the drug.

Because aminotransferase elevations have been reported as a manifestation of COVID-19 disease and because clinical trial data indicate that the incidence of aminotransferase elevations is similar in patients receiving remdesivir or placebo, discerning the contribution of remdesivir to such elevations in this patient population is challenging.

Grade 1 and 2 aminotransferase elevations observed in healthy individuals who received remdesivir (initial 200-mg dose followed by 100-mg doses for up to 10 days); these elevations resolved after the drug was discontinued.

In a phase 3, placebo-controlled trial in hospitalized adults with severe COVID-19, grade 3 or 4 ALT and/or AST elevations reported in 3–6% of patients receiving remdesivir compared with 6–8% of those receiving placebo.

In a phase 3, randomized, open-label trial in hospitalized patients with severe COVID-19, grade 3 or 4 aminotransferase elevations reported in 2–8% of those treated with a 5- or 10-day remdesivir regimen.

In a phase 3, randomized, open-label trial in hospitalized patients with moderate COVID-19, grade 3 or 4 ALT and/or AST elevations reported in 2–3% of those receiving remdesivir compared with 2–8% of those receiving standard of care only.

Assess hepatic function prior to and as clinically appropriate during remdesivir treatment.

Consider discontinuing remdesivir in patients who develop ALT concentrations >10 times the ULN during treatment.

Discontinue remdesivir in patients who develop elevated ALT concentrations accompanied by signs or symptoms of liver inflammation.

Risk of Reduced Antiviral Activity if Used Concomitantly with Chloroquine or Hydroxychloroquine

Concomitant use of remdesivir and chloroquine or hydroxychloroquine not recommended because of in vitro evidence that chloroquine antagonizes intracellular metabolic activation and antiviral activity of remdesivir.

In vitro, antiviral activity of remdesivir was antagonized by chloroquine in dose-dependent manner when the drugs were incubated together at clinically relevant concentrations in human epithelial type 2 (HEp-2) cells infected with respiratory syncytial virus (RSV). Increasing chloroquine concentrations reduced formation of the pharmacologically active remdesivir triphosphate metabolite (GS-443902) in vitro in normal human bronchial epithelial cells.

EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

FDA EUA that permits use of remdesivir for treatment of COVID-19 in pediatric patients weighing 3.5 to <40 kg or those <12 years of age weighing ≥3.5 kg with suspected or laboratory-confirmed COVID-19 requires that the drug be administered in an inpatient hospital setting (or healthcare setting capable of providing acute care comparable to inpatient hospital care) via IV infusion using the dosages recommended in the EUA. (See Coronavirus Disease 2019 [COVID-19] under Uses.)

Only limited data available to date regarding adverse effects associated with use of remdesivir in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg. Serious and unexpected adverse events may occur that have not been previously reported with the drug.

To mitigate the risks in this patient population, the EUA includes certain mandatory requirements (including providing information to the patient or parent/caregiver and ensuring that all medication errors and serious adverse events are reported to FDA).

Completion of FDA MedWatch forms to report all medication errors and adverse events occurring during remdesivir treatment is mandatory when used under the EUA. Consult FDA Fact Sheet for Healthcare Providers that is provided with the drug and available at FDA website ([Web]) for requirements and instructions regarding reporting of adverse reactions and medication errors.

Specific Populations

Pregnancy

Risk Summary: Data regarding use of remdesivir during pregnancy available from published case reports and a compassionate use access program are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Although pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality, the estimated background risk of major birth defects and miscarriage related to the disease is unknown. In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryofetal development when administered to pregnant animals (rats and rabbits) at GS-441524 (predominant circulating metabolite) AUC 4 times the exposure in humans at the recommended human dose (RHD).

Animal Data: When administered via IV injection to pregnant rats and rabbits (up to 20 mg/kg daily) on gestation days 6 through 17 and 7 through 20, respectively, and also to rats from gestation day 6 to lactation/postpartum day 20, no adverse effects on embryofetal (rats and rabbits) or pre/postnatal (rats) development observed at doses nontoxic in pregnant animals. During organogenesis, exposures to GS-441524 were 4 times higher (rats and rabbits) than exposure in humans at RHD. In a pre/postnatal development study, exposures to GS-441524 were similar to human exposures at RHD.

Some data are available regarding use of remdesivir in pregnant women hospitalized with moderate COVID-19. An open-label, non-randomized, phase 1 study is ongoing to evaluate safety and pharmacokinetics of the drug in pregnant women with COVID-19.

NIH COVID-19 Treatment Guidelines Panel states that remdesivir should not be withheld from a pregnant woman if it is otherwise indicated.

Lactation

Risk Summary: No information regarding distribution of remdesivir into human milk, effects on breast-fed infant, or effects on milk production. In animal studies, remdesivir and its metabolites detected in nursing pups of rats given remdesivir, likely due to presence in milk.

Consider the developmental and health benefits of breast-feeding along with the mother’s clinical need for remdesivir and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition. Women with COVID-19 who are breast-feeding should follow clinical guidelines to avoid exposing the infant to the virus.

Animal Data: Following daily IV administration of remdesivir to pregnant rats from gestation day 6 to lactation day 20, remdesivir and its metabolites detected in plasma of nursing rat pups, likely due to presence of the drug and/or its metabolites in milk. Exposures in nursing pups were approximately 1% of maternal exposures on lactation day 10.

Pediatric Use

Safety and efficacy for treatment of COVID-19 have been established in pediatric patients ≥12 years of age weighing ≥40 kg based on extrapolation of pediatric efficacy from adequate and well-controlled studies in adults. Clinical trials have included 30 adults weighing 40–50 kg; safety of the drug in this weight group was comparable to that in adults weighing >50 kg. Although clinical data are limited, 39 pediatric patients ≥12 years of age weighing ≥40 kg received remdesivir in a compassionate use access program.

Safety and efficacy for treatment of COVID-19 not established in pediatric patients <12 years of age or weighing <40 kg. Available under an EUA for treatment of suspected or laboratory-confirmed COVID-19 in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg. (See Coronavirus Disease 2019 [COVID-19] under Uses.)

Pharmacokinetics not evaluated in pediatric patients.

Based on modeling and simulation, dosages recommended for pediatric patients are expected to result in steady-state exposures of remdesivir and metabolites comparable to those observed in healthy adults following administration of recommended adult dosages.

Open-label, single-arm phase 2/3 study ongoing to evaluate safety, pharmacokinetics, and efficacy of remdesivir in pediatric patients from birth to <18 years of age.

Use only remdesivir lyophilized powder (not the solution concentrate) to prepare remdesivir IV infusions for pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg. (See Administration under Dosage and Administration.)

eGFR must be determined prior to and as clinically appropriate during remdesivir treatment in pediatric patients ≥12 years of age weighing ≥40 kg.

When used under the EUA in pediatric patients 3.5 to <40 kg or those <12 years of age weighing ≥3.5 kg, eGFR must be determined in those >28 days of age and Scr must be determined in full-term neonates 7–28 days of age prior to and as clinically appropriate during remdesivir treatment. Monitor renal function during treatment in all pediatric patients and consider discontinuing the drug in the setting of substantial decline.

Remdesivir not recommended in pediatric patients >28 days of age with eGFR <30 mL/minute or in full-term neonates 7–28 days of age with Scr ≥1 mg/dL. (See Renal Impairment under Cautions.)

Geriatric Use

Reported clinical experience has not identified differences in responses to remdesivir between geriatric and younger patients. Although dosage adjustment not needed in patients >65 years of age, use appropriate caution and monitoring because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or other drug therapy in the elderly.

Hepatic Impairment

Assess hepatic function prior to and as clinically appropriate during remdesivir treatment.

Aminotransferase elevations observed in healthy individuals and patients with COVID-19 who received the drug. (See Increased Risk of Aminotransferase Elevations under Cautions.)

Pharmacokinetics not evaluated in patients with hepatic impairment.

Renal Impairment

Must assess renal function prior to and as clinically appropriate during remdesivir treatment.

Adults and pediatric patients >28 days of age: Assess eGFR to monitor renal function. Remdesivir not recommended in those with eGFR <30 mL/minute.

Full-term neonates 7–28 days of age: Assess Scr to monitor renal function. Remdesivir not recommended in those with Scr ≥1 mg/dL.

Remdesivir preparations contain the excipient betadex sulfobutyl ether sodium (sulfobutylether β-cyclodextrin sodium; SBECD). Each single-dose vial of lyophilized powder containing 100 mg of remdesivir contains 3 g of SBECD; each 100-mg single-dose vial of solution concentrate containing remdesivir 100 mg/20 mL (5 mg/mL) contains 6 g of SBECD. Because SBECD is renally eliminated by glomerular filtration and may accumulate in patients with decreased renal function, drugs formulated with SBECD not recommended in patients with eGFR <30 mL/minute. Some clinicians state that the limited duration of remdesivir treatment and relatively low SBECD concentrations in remdesivir preparations suggest that benefits of the drug may outweigh risks of the excipient in certain patients with renal impairment.

A phase 3 study is ongoing to evaluate efficacy and safety for treatment of COVID-19 in hospitalized patients with severely reduced renal function.

Pharmacokinetics not specifically studied in patients with renal impairment. Some data available regarding use for treatment of COVID-19 in patients with end-stage renal disease (ESRD) undergoing hemodialysis. (See Special Populations under Pharmacokinetics.)

Common Adverse Effects

Adverse effects reported in ≥5% of patients receiving remdesivir include nausea and increased ALT and AST concentrations.

Phase 3, adaptive, randomized, placebo-controlled trial in hospitalized adults with mild/moderate or severe COVID-19 (NCT04280705; ACTT-1): Serious adverse events reported in 51% of patients in remdesivir group and 57% in placebo group. Adverse events leading to discontinuance of treatment reportedly occurred in 2% of patients receiving remdesivir (seizure, infusion-related reactions, increased aminotransferase concentrations, decreased GFR, acute kidney injury) and 3% of those receiving placebo.

Phase 3, randomized, open-label trial in hospitalized adults with severe COVID-19 (NCT04292899; GS-US-540-5773; SIMPLE-Severe): Adverse events reported in 70 or 74% of patients who received a 5- or 10-day remdesivir regimen, respectively; serious adverse events (e.g., respiratory distress or failure, septic shock) reported in 21 or 35%, respectively, and grade 3 or greater adverse events reported in 30 or 43%, respectively. Drug discontinued because of adverse events in 4% of patients in 5-day group and 10% of patients in 10-day group. Most common adverse events overall were nausea (10 or 9%), acute respiratory failure (6 or 11%), increased ALT concentrations (6 or 8%), and constipation (7% in both groups).

Phase 3, randomized, open-label trial in hospitalized adults with moderate COVID-19 (NCT04292730; GS-US-540-5774; SIMPLE-Moderate): Adverse events reported in 51 or 59% of patients who received a 5- or 10-day remdesivir regimen, respectively; serious adverse events reported in 5% of patients in both treatment groups, and grade 3 or greater adverse events reported in 11 or 12% of patients receiving 5- or 10-day regimen, respectively. Most common adverse events in patients receiving these respective regimens were nausea (10 or 9%), diarrhea (6 or 5%), hypokalemia (5 or7%), and headache (5% in both treatment groups). Four patients (2%) in 5-day group and 8 patients (4%) in 10-day group discontinued remdesivir due to an adverse event.

Interactions for Remdesivir

In vitro, remdesivir is a substrate of CYP3A4, P-glycoprotein (P-gp), and organic anion transporting polypeptide 1B1 (OATP1B1); the predominant circulating metabolite (GS-441524) is a substrate for OATP1B1 and OATP1B3.

Remdesivir inhibits CYP3A4, OATP1B1, OATP1B3, and multidrug and toxin extrusion transporter (MATE) 1 in vitro.

Clinical relevance of in vitro interaction assessments not established.

Drug-drug interaction trials of remdesivir and concomitant medications not conducted in humans.

Specific Drugs

Drug

Interaction

Comments

Chloroquine and hydroxychloroquine

In vitro evidence that antiviral activity of remdesivir is antagonized by chloroquine and hydroxychloroquine in dose-dependent manner; in vitro evidence that increasing concentrations reduce formation of active remdesivir metabolite (GS-443902)

Concomitant use not recommended

Dexamethasone

Minimal or no reduction in remdesivir exposure expected

Influenza antivirals (baloxavir, oseltamivir)

Clinically important interactions not expected

Remdesivir Pharmacokinetics

Absorption

Plasma Concentrations

Pharmacokinetics of remdesivir evaluated in healthy adults in several phase 1 trials.

Prodrug that is initially metabolized to GS-441524 (predominant circulating metabolite) and GS-704277 and is converted intracellularly to the active nucleoside triphosphate metabolite (GS-443902). (See Elimination under Pharmacokinetics.)

Following IV infusion over 30 minutes in healthy adults, peak plasma concentrations of remdesivir are attained within 0.7 hours and peak plasma concentrations of GS-441524 and GS-704277 are attained within 1.5–2 and 0.75 hours, respectively.

Data from a single-dose pharmacokinetic study in healthy adults indicate that pharmacokinetics of the lyophilized powder and solution concentrate formulations of remdesivir are comparable.

Distribution

Extent

High intracellular concentrations of the active triphosphate metabolite (GS-443902) reported in peripheral blood mononuclear cells (PBMCs) of healthy adults 24 hours after a single dose of remdesivir given by IV infusion; these concentrations were up to 370-fold higher than the in vitro 50% effective concentration (EC50) of the drug reported for SARS-CoV-2.

Plasma Protein Binding

Remdesivir is 88–94% bound to plasma proteins; GS-441524 and GS-704277 are 2 and 1% bound to plasma proteins, respectively.

Elimination

Metabolism

Metabolized (10%) by CYP3A4.

Metabolized intracellularly to a nucleoside monophosphate intermediate (GS-704277) by carboxyesterase 1 and/or cathepsin A, depending on the cell type. The nucleoside monophosphate is subsequently phosphorylated by cellular kinases to form the pharmacologically active nucleoside triphosphate metabolite (GS-443902).

Elimination Route

Data from healthy adults indicate that 10% of a remdesivir dose eliminated in urine as unchanged drug and 49 and 2.9% of the dose eliminated in urine as GS-441524 and GS-704277, respectively.

Half-life

In healthy adults, remdesivir has a plasma half-life of 1 hour and GS-441524 and GS-704277 have plasma half-lives of 27 and 1.3 hours, respectively.

GS-441524 has an intracellular half-life in PBMCs of >35 hours; median half-life of pharmacologically active metabolite (GS-443902) in PBMCs reported to be 36–49 hours.

Special Populations

Pharmacokinetics not evaluated in pediatric or geriatric patients to date.

Possible effects of age, sex, race, hepatic impairment, or renal impairment on remdesivir pharmacokinetics not evaluated to date.

ESRD undergoing hemodialysis: Data from a few adults who received recommended 5-day remdesivir regimen indicate remdesivir and/or GS-441524 exposures approximately 3–10 times higher compared with healthy adults. Hemodialysis performed prior to second and fifth remdesivir doses in these patients resulted in post-hemodialysis remdesivir and/or GS-441524 concentrations 45–50% lower than pre-hemodialysis concentrations; no clinically important accumulation.

Stability

Storage

Parenteral

Powder for Injection, for IV Infusion

Single-dose vials of lyophilized powder (100 mg): <30°C. Should appear as a white to off-white to yellow powder.

Reconstituted vials: Immediately dilute in 0.9% sodium chloride injection to provide the final solution for IV infusion. (See Administration under Dosage and Administration.)

Diluted solution: May be stored for up to 24 hours at 20–25°C or for up to 48 hours at 2–8°C after final dilution in IV infusion bag containing 0.9% sodium chloride. Perform dilution for IV infusion on the same day it is administered; whenever possible, administer immediately following dilution.

Solution Concentrate for Injection, for IV Infusion

Single-dose vials of solution concentrate (100 mg/20 mL [5 mg/mL]): Refrigerate (2–8°C). Should appear clear and colorless to yellow.

After removal from refrigeration, sealed vials may be stored for up to 12 hours at room temperature immediately prior to dilution.

Diluted solution: May be stored for up to 24 hours at 20–25°C or for up to 48 hours at 2–8°C after dilution in an IV infusion bag containing 0.9% sodium chloride. Perform dilution for IV infusion within the same day that it is administered; whenever possible, administer immediately following dilution.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1 26

Compatible

0.9% sodium chloride

Actions and Spectrum

  • Adenosine nucleotide prodrug that is metabolized intracellularly to form the pharmacologically active nucleoside triphosphate metabolite (GS-443902). RNA polymerase inhibitor; direct-acting antiviral (DAA).

  • Mechanism(s) of action against susceptible viruses, including coronaviruses such as SARS-CoV-2 (causative agent of COVID-19), not fully elucidated.

  • Following conversion to active triphosphate metabolite (GS-443902), the drug acts as an analog of adenosine triphosphate (ATP) and competes with high selectivity with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which results in delayed chain termination during replication of the viral RNA. Other mechanisms also may be involved. Weak inhibitor of mammalian DNA and RNA polymerases, including human mitochondrial RNA.

  • Broad spectrum of activity against RNA viruses, including various Coronaviridae (human and animal), Filoviridae (e.g., Ebola virus), and Paramyxoviridae (e.g., Nipah virus, respiratory syncytial virus).

  • Active in vitro against SARS-CoV-1 (causative agent of severe acute respiratory syndrome [SARS]) and MERS-CoV (causative agent of Middle East respiratory syndrome [MERS]), including in infected primary human airway epithelial cell (HAE) cultures. Also active in animal models of SARS and MERS; prevented MERS in Rhesus macaques when given before infection and provided benefits when given after the animals were already infected.

  • Active in vitro against SARS-CoV-2, including in Vero E6 cells. Exhibited cell culture antiviral activity against a clinical isolate of SARS-CoV-2 in HAE cells (50% effective concentration [EC50] 9.9 nM after 48 hours of treatment). Also inhibited replication of SARS-CoV-2 in the continuous human lung epithelial cell line Calu-3 (EC50 of 280 nM after 72 hours of treatment) and A549 cells expressing human angiotensin-converting enzyme (A549-hACE2) (EC50 of 115 nM after 48 hours of treatment).

  • Antiviral activity also demonstrated in SARS-CoV-2-infected Rhesus macaques. In one study, treatment with a 6-day regimen of IV remdesivir initiated 12 hours after virus inoculation in the monkeys was associated with some benefits (lower disease severity scores, fewer pulmonary infiltrates, lower virus titers in bronchoalveolar lavage samples) compared with vehicle control; remdesivir treatment did not reduce viral loads or infectious virus titers in nose, throat, or rectal swabs of these monkeys compared with vehicle control.

  • 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 a 5.6-fold reduction in susceptibility to remdesivir. The mutant viruses showed reduced viral fitness in cell culture; introduction of the corresponding substitutions (F480L and V557L) into SARS-CoV resulted in a 6-fold reduction in susceptibility to remdesivir in cell culture and attenuated SARS-CoV pathogenesis in a mouse model.

  • In vitro development of resistance to remdesivir reported in SARS-CoV-1.

  • In vitro development of resistance to remdesivir in SARS-CoV-2 in cell culture not assessed to date. Clinical data not available to date regarding development of remdesivir resistance in SARS-CoV-2 in patients treated with the drug.

Advice to Patients

  • Advise patients to read the manufacturer's patient information.

  • Inform patients or parents/caregivers that hypersensitivity reactions have been reported during and after remdesivir administration. Importance of informing clinicians if signs and symptoms of hypersensitivity (changes in heart rate, fever, shortness of breath, wheezing, rash, nausea, sweating, shivering, or swelling of the lips, face, or throat) occur.

  • Inform patients or parents/caregivers that remdesivir may increase the risk of hepatic laboratory abnormalities. Importance of immediately informing clinicians if symptoms of liver inflammation occur.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements. Importance of informing clinicians if currently taking chloroquine or hydroxychloroquine.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Inform patients that it is not known whether remdesivir can cause fetal harm or whether the drug is distributed into milk.

  • When remdesivir is used under the EUA in pediatric patients weighing 3.5 to <40 kg or <12 years of age weighing ≥3.5 kg, the Fact Sheet for Parents and Caregivers that is provided with the drug and available at the FDA website ([Web]) must be given to the parent/caregiver prior to administration of the drug. In addition, inform the parent/caregiver (and patient if age-appropriate) that they have the option to accept or refuse remdesivir, inform them about the important known and potential risks and benefits of remdesivir and the extent to which risks and benefits are unknown, and provide information on available alternative treatments and the risks and benefits of those alternatives. If providing this information will delay administration of remdesivir to a degree that would endanger the life of the patient, the information must be provided to the parent/caregiver as soon as feasible after remdesivir is administered.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Healthcare providers should contact the manufacturer or the manufacturer's sole US distributor (AmerisourceBergen) at 800-746-6273 to obtain remdesivir for use under the FDA-labeled indication or for use under the FDA Emergency Use Authorization (EUA). The manufacturer has alerted healthcare providers that there are variations in remdesivir packaging and labeling depending on whether the drug was originally manufactured for use under the EUA or for commercial use. (See General under Dosage and Administration.)

Remdesivir

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Powder for injection, for IV infusion only

100 mg

Veklury

Gilead

Concentrate for injection, for IV infusion only

100 mg/20 mL (5 mg/mL)

Veklury

Gilead

AHFS DI Essentials™. © Copyright 2021, Selected Revisions April 19, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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