Remdesivir: Difference between revisions

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==Adult Dosing==
==Adult Dosing==
===[[COVID]]===
*Loading dose: 200 mg IV administered on day 1
*Loading dose: 200 mg IV administered on day 1
*Maintenance dose: 100 mg IV daily for duration of hospitalization, up to 10 days<ref>Gilead Sciences. Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19). Available from: https://clinicaltrials.gov/ct2/show/NCT04292899. NLM identifier: NCT04292899. Accessed March 21, 2020.</ref>
*Maintenance dose: 100 mg IV daily for duration of hospitalization, or up to 5-10 days (whichever is shorter)
**NIH consensus pannel recommends 5 days<ref>https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-adults--therapeutic-management/</ref>
**Drug insert states 10 days<ref>Gilead Sciences. Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19). Available from: https://clinicaltrials.gov/ct2/show/NCT04292899. NLM identifier: NCT04292899. Accessed March 21, 2020.</ref>


==Pediatric Dosing==
==Pediatric Dosing==
*Not studied in pediatric patients
*Not studied in pediatric patients
===[[COVID]]===
*Has not been evaluated in pediatric patients aged <12 years or weighing <40 kg.<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>
*Is available through an FDA EUA for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg.<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>
*A clinical trial is currently evaluating the pharmacokinetics of remdesivir in children (ClinicalTrials.gov identifier NCT04431453).<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>


==Special Populations==
==Special Populations==
===[[Drug pregnancy categories|Pregnancy Rating]]===
===[[Drug pregnancy categories|Pregnancy Rating]]===
*No data
*Pregnant patients were excluded from the clinical trials that evaluated the safety and efficacy for the treatment of COVID-19, but preliminary reports of use in pregnant patients through the remdesivir compassionate use program are reassuring.<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>
*Among 86 pregnant and postpartum hospitalized patients with severe COVID-19 who received compassionate use remdesivir, the therapy was well tolerated, with a low rate of serious adverse events.<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>
*Should not be withheld from pregnant patients if it is otherwise indicated.<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21</ref>


===Lactation risk===
===Lactation risk===
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*Pediatric: Unknown
*Pediatric: Unknown


==Contraindications==
==Contraindications<ref>https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/</ref>==
*Allergy to class/drug
*Allergy to class/drug
*Alanine transaminase or aspartate transaminase >5 times the upper limit of normal
*Creatinine clearance of <30 mL/minute
**Can be considered in patients with calculated creatinine clearance of <30 mL/minute and in patients receiving hemodialysis if the benefits outweigh the risk (limited data).
**At this time, there are no recommended dose adjustments for this patient population.
*Pediatric patients 3.5kg to 12 years of age; should not be given if ALT is >10 times normal.<ref>https://www.fda.gov/media/137566/download</ref>


==Adverse Reactions==
==Adverse Reactions==

Latest revision as of 20:10, 18 January 2022

Administration

  • Type: Antiviral
  • Dosage Forms: 100 mg, 200 mg
  • Routes of Administration: IV
  • Common Trade Names: N/a

Adult Dosing

COVID

  • Loading dose: 200 mg IV administered on day 1
  • Maintenance dose: 100 mg IV daily for duration of hospitalization, or up to 5-10 days (whichever is shorter)
    • NIH consensus pannel recommends 5 days[1]
    • Drug insert states 10 days[2]

Pediatric Dosing

  • Not studied in pediatric patients

COVID

  • Has not been evaluated in pediatric patients aged <12 years or weighing <40 kg.[3]
  • Is available through an FDA EUA for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg.[4]
  • A clinical trial is currently evaluating the pharmacokinetics of remdesivir in children (ClinicalTrials.gov identifier NCT04431453).[5]

Special Populations

Pregnancy Rating

  • Pregnant patients were excluded from the clinical trials that evaluated the safety and efficacy for the treatment of COVID-19, but preliminary reports of use in pregnant patients through the remdesivir compassionate use program are reassuring.[6]
  • Among 86 pregnant and postpartum hospitalized patients with severe COVID-19 who received compassionate use remdesivir, the therapy was well tolerated, with a low rate of serious adverse events.[7]
  • Should not be withheld from pregnant patients if it is otherwise indicated.[8]

Lactation risk

  • No data

Renal Dosing

  • Adult: Unknown
  • Pediatric: Unknown

Hepatic Dosing

  • Adult: Unknown
  • Pediatric: Unknown

Contraindications[9]

  • Allergy to class/drug
  • Alanine transaminase or aspartate transaminase >5 times the upper limit of normal
  • Creatinine clearance of <30 mL/minute
    • Can be considered in patients with calculated creatinine clearance of <30 mL/minute and in patients receiving hemodialysis if the benefits outweigh the risk (limited data).
    • At this time, there are no recommended dose adjustments for this patient population.
  • Pediatric patients 3.5kg to 12 years of age; should not be given if ALT is >10 times normal.[10]

Adverse Reactions

Serious

  • Unknown

Common

  • Unknown

Pharmacology

  • Half-life: Unknown
  • Metabolism: Unknown
  • Excretion: Unknown

Mechanism of Action

  • Adenosine nucleotide analog that interferes with the action of viral RNA polymerase, resulting in decreased virus production[11]

Comments

Remdesivir is a novel antiviral currently being studied in clinical trials for use in COVID-19. It was initially developed for treatment of Ebola and has also been shown to have some effect on SARS and MERS, as well as some other RNA viruses.[12]

See Also

References

  1. ↑ https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-adults--therapeutic-management/
  2. ↑ Gilead Sciences. Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19). Available from: https://clinicaltrials.gov/ct2/show/NCT04292899. NLM identifier: NCT04292899. Accessed March 21, 2020.
  3. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  4. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  5. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  6. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  7. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  8. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/ Accessed: 1/15/21
  9. ↑ https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/remdesivir/
  10. ↑ https://www.fda.gov/media/137566/download
  11. ↑ US 9724360, Chun BK, Clarke MO, Doerffler E, Hui HC, Jordan R, Mackman RL, Parrish JP, Ray AS, Siegel D, "Methods for treating Filoviridae virus infections", issued 19 July 2017, assigned to Gilead Sciences Inc.
  12. ↑ Warren TK, Jordan R, Lo MK, et al. Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys [published correction appears in ACS Chem Biol. 2016 May 20;11(5):1463]. Nature. 2016;531(7594):381–385. doi:10.1038/nature17180
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