Severe Acute Respiratory Syndrome (SARS) Treatments

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Brand Name

Veklury

Generic Name
Remdesivir
View Brand Information
FDA approval date: November 01, 2020
Classification: SARS-CoV-2 Nucleotide Analog RNA Polymerase Inhibitor
Form: Injection

What is Veklury (Remdesivir)?

VEKLURY is indicated for the treatment of coronavirus disease 2019 in adults and pediatric patients who are : Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. VEKLURY is a severe acute respiratory syndrome coronavirus 2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 in adults and pediatric patients who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
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Related Clinical Trials

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

Summary: This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study interventio...

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Brand Information

Veklury (remdesivir)
1INDICATIONS AND USAGE
VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are
  • Hospitalized, or
  • Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
2DOSAGE FORMS AND STRENGTHS
VEKLURY for injection, 100 mg, available as a sterile, preservative-free white to off-white to yellow lyophilized powder in single-dose vial for reconstitution.
3CONTRAINDICATIONS
VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any components of the product
4ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
  • Hypersensitivity Including Infusion-related and Anaphylactic Reactions
  • Increased Risk of Transaminase Elevations
4.1Clinical 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.
5OVERDOSAGE
There is no human experience of acute overdosage with VEKLURY. Treatment of overdose with VEKLURY should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with VEKLURY.
6DESCRIPTION
VEKLURY contains remdesivir, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor. The chemical name for remdesivir is 2-ethylbutyl
Chemical Structure
VEKLURY for injection contains 100 mg of remdesivir as a sterile, preservative-free lyophilized white to off-white to yellow powder in a single-dose clear glass vial. It requires reconstitution and then further dilution prior to administration by intravenous infusion
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 100 mg Vial Label
Veklury
Single-Dose Vial: Discard
Must be reconstituted and
90288101
PRINCIPAL DISPLAY PANEL - 100 mg Vial Label
9PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
NDC 61958-2901-2
Veklury
Single-Dose Vial: Discard
Must be reconstituted and
GILEAD
PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton