Veklury

Last updated on RxList: 3/3/2021
Veklury Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Veklury?

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization.

What Are Side Effects of Veklury?

Side effects of Veklury include:

  • nausea,
  • increased ALT,
  • increased AST,
  • hypersensitivity reactions,
  • seizures, and
  • rash

Dosage for Veklury

The recommended dosage of Veklury in adults and pediatric patients 12 years of age and older and weighing at least 40 kg 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 infused over 30 to 120 minutes. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Veklury In Children

The safety and effectiveness of Veklury for the treatment of COVID-19 have been established in pediatric patients 12 years and older and weighing at least 40 kg. Use in this age group is based on extrapolation of pediatric efficacy from adequate and well-controlled studies in adults.

All pediatric patients 12 years of age and older and weighing at least 40 kg must have eGFR determined before starting Veklury and while receiving Veklury as clinically appropriate.

The safety and effectiveness of Veklury have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.

What Drugs, Substances, or Supplements Interact with Veklury?

Veklury may interact with other medicines such as:

  • chloroquine phosphate and
  • hydroxychloroquine sulfate

Tell your doctor all medications and supplements you use.

Veklury During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Veklury; it is unknown how it would affect a fetus. It is unknown if Veklury passes into breast milk.

Breastfeeding females with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Consult your doctor before breastfeeding.

Additional Information

Our Veklury (remdesivir) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Veklury Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during or after the injection. Tell your caregiver right away if you have:

  • severe headache, pounding in your neck or ears;
  • fast, slow, or pounding heartbeats;
  • wheezing, trouble breathing;
  • swelling in your face;
  • nausea;
  • fever, chills, or shivering;
  • itching, sweating; or
  • a light-headed feeling, like you might pass out;

Common side effects may include:

  • nausea; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Veklury (Remdesivir for Injection)

Veklury Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Hypersensitivity Including Infusion-related and Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
  • Increased Risk of Transaminase Elevations [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of VEKLURY is based on data from three Phase 3 studies in 1,313 hospitalized adult subjects with COVID-19, from four Phase 1 studies in 131 healthy adults, and from patients with COVID-19 who received VEKLURY under the Emergency Use Authorization or in a compassionate use program.

Clinical Trials Experience In Subjects With COVID-19

NIAID ACTT-1 was a randomized, double-blind, placebo-controlled clinical trial in hospitalized subjects with mild, moderate, and severe COVID-19 treated with VEKLURY (n=532) or placebo (n=516) for up to 10 days. Subjects treated with VEKLURY received 200 mg on Day 1 and 100 mg once daily on subsequent days [see Clinical Studies]. The collection of adverse event data in this trial was limited to severe (Grade 3) or potentially life-threatening (Grade 4) adverse events, serious adverse events, adverse events leading to study drug discontinuation, and moderate (Grade 2) severity or higher hypersensitivity reactions. Rates of adverse reactions (≥ Grade 3), serious adverse reactions, and adverse reactions leading to treatment discontinuation are presented in Table 5.

Table 5 Summary of Adverse Reaction Rates in Subjects with Mild, Moderate, or Severe COVID-19 in NIAID ACTT-1

Types of Adverse ReactionsVEKLURY
N=532
n (%)
Placebo
N=516
n (%)
Adverse reactions, Grades ≥341 (8%)46 (9%)
Serious adverse reactions2 (0.4%)a3 (0.6%)
Adverse reactions leading to treatment discontinuation11 (2%)b15 (3%)
a. Seizure (n=1), infusion-related reaction (n=1).
b. Seizure (n=1), infusion-related reaction (n=1), transaminases increased (n=3), ALT increased and AST increased (n=1), GFR decreased (n=2), acute kidney injury (n=3).

Study GS-US-540-5773 was a randomized, open-label clinical trial in hospitalized subjects with severe COVID-19 treated with VEKLURY 200 mg on Day 1 and 100 mg once daily for 5 (n=200) or 10 days (n=197). Adverse reactions were reported in 33 (17%) subjects in the 5-day group and 40 (20%) subjects in the 10-day group [see Clinical Studies]. The most common adverse reactions occurring in at least 5% of subjects in either the VEKLURY 5-day or 10-day group, respectively, were nausea (5% vs 3%), AST increased (3% vs 6%), and ALT increased (2% vs 7%). Rates of any adverse reactions, serious adverse reactions, and adverse reactions leading to treatment discontinuation are presented in Table 6.

Table 6 Summary of Adverse Reaction Rates in Subjects with Severe COVID-19 in Study5773

Types of Adverse ReactionsVEKLURY
5 Days
N=200
n (%)
VEKLURY
10 Days
N=197
n (%)
Any adverse reaction, all Grades33 (17%)40 (20%)
Serious adverse reactions3 (2%)a4 (2%)a
Adverse reactions leading to treatment discontinuation5 (3%)b9 (5%)b
a. Transaminases increased (n=5), hepatic enzyme increased (n=1), hypertransaminasaemia (n=1).
b. Transaminases increased (n=4), hepatic enzyme increased (n=2), LFT increased (n=2), hypertransaminasaemia (n=1), ALT increased (n=1), ALT increased and AST increased (n=2), injection site erythema (n=1), rash (n=1).

Study GS-US-540-5774 was a randomized, open-label clinical trial in hospitalized subjects with moderate COVID-19 treated with VEKLURY 200 mg on Day 1 and 100 mg daily for 5 (n=191) or 10 days (n=193), or standard of care (SOC) only (n=200) [see Clinical Studies]. Adverse reactions were reported in 36 (19%) subjects in the 5-day group and 25 (13%) subjects in the 10-day group. The most common adverse reaction occurring in at least 5% of subjects in the VEKLURY groups was nausea (7% in the 5-day group, 4% in the 10-day group). Rates of any adverse reactions, serious adverse reactions, and adverse reactions leading to treatment discontinuation are presented in Table 7.

Table 7 Summary of Adverse Reactiona Rates in Subjects with Moderate COVID-19 in Study 5774

Types of Adverse ReactionsVEKLURY
5 Days
N=191
n (%)
VEKLURY
10 Days
N=193
n (%)
Any adverse reaction, all Grades36 (19%)25 (13%)
Serious adverse reactions1 (<1%)b0
Adverse reactions leading to treatment discontinuation4 (2%)c4 (2%)c
a. Attribution of events to study drug was not performed for the SOC group.
b. Heart rate decreased.
c. ALT increased (n=2), ALT increased and AST increased (n=1), hypertransaminasaemia (n=1), blood alkaline phosphatase increased (n=1), rash (n=2), heart rate decreased (n=1).

Less Common Adverse Reactions

Clinically significant adverse reactions that were reported in <2% of subjects exposed to VEKLURY in clinical trials are listed below:

  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
  • Generalized seizure
  • Rash
Emergency Use Authorization Experience In Patients With COVID-19

The following adverse reactions have been identified during use of VEKLURY under Emergency Use Authorization:

  • General disorders and administration site conditions: Administration site extravasation
  • Skin and subcutaneous tissue disorders: Rash
  • Immune system disorders: Anaphylaxis, angioedema, infusion-related reactions, hypersensitivity
  • Investigations: Transaminase elevations
Laboratory Abnormalities

Study GS-US-399-5505 was a Phase 1, randomized, blinded, placebo-controlled clinical trial in healthy volunteers administered VEKLURY 200 mg on Day 1 and 100 mg for either 4 days or 9 days. Mild (Grade 1, n=8) to moderate (Grade 2, n=1) elevations in ALT were observed in 9 of 20 subjects receiving 10 days of VEKLURY; the elevations in ALT resolved upon discontinuation of VEKLURY. No subjects (0 of 9) who received 5 days of VEKLURY had graded increases in ALT.

The frequencies of laboratory abnormalities (Grades 3-4) occurring in at least 3% of subjects with COVID-19 receiving VEKLURY in Trials NIAID ACTT-1, 5773, and 5774 are presented in Table 8, Table 9, and Table 10, respectively.

Table 8: Laboratory Abnormalities (Grades 3-4) Reported in ≥3% of Subjects Receiving VEKLURY in NIAID ACTT-1

Laboratory Parameter AbnormalityaVEKLURY 10 Days
N=532
Placebo
N=516
ALT increased3%6%
AST increased6%8%
Bilirubin increased2%5%
Creatinine clearance decreasedb18%20%
Creatinine increased15%16%
eGFR decreased18%24%
Glucose increased12%13%
Hemoglobin decreased15%22%
Lymphocytes decreased11%18%
Prothrombin time increased9%4%
a. Frequencies are based on treatment-emergent laboratory abnormalities. Graded per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017.
b. Based on the Cockcroft-Gault formula.

Table 9: Laboratory Abnormalities (Grades 3-4) Reported in ≥3% of Subjects Receiving VEKLURY in Trial 5773

Laboratory Parameter AbnormalityaVEKLURY
5 Days
N=200
VEKLURY
10 Days
N=197
ALT increased6%8%
AST increased7%6%
Creatinine clearance decreasedb10%19%
Creatinine increased5%15%
Glucose increased11%8%
Hemoglobin decreased6%8%
a. Frequencies are based on treatment-emergent laboratory abnormalities. Graded per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017.
b. Based on the Cockcroft-Gault formula.

Table 10: Laboratory Abnormalities (Grades 3-4) Reported in ≥3% of Subjects Receiving VEKLURY in Trial 5774

Laboratory Parameter AbnormalityaVEKLURY
5 Days
N=191
VEKLURY
10 Days
N=193
SOC
N=200
ALT increased2%3%8%
Creatinine clearance decreasedb2%5%8%
Glucose increased4%3%2%
Hemoglobin decreased3%1%6%
SOC=Standard of care.
a. Frequencies are based on treatment-emergent laboratory abnormalities. Graded per Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017.
b. Based on the Cockcroft-Gault formula.

Read the entire FDA prescribing information for Veklury (Remdesivir for Injection)

© Veklury Patient Information is supplied by Cerner Multum, Inc. and Veklury Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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