Remdesivir - Revision history

Rossdonaldson1: /* Contraindications */

2022-01-18T20:10:08Z

Contraindications

← Revisión anterior		Revisión del 20:10 18 ene 2022
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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==

Rossdonaldson1: /* Adult Dosing */

2022-01-18T20:09:33Z

Adult Dosing

← Revisión anterior		Revisión del 20:09 18 ene 2022
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	===[[COVID]]===		===[[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>
	~~{{COVID Remdesivir}}~~		**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==

Rossdonaldson1 at 20:04, 18 January 2022

2022-01-18T20:04:09Z

← Revisión anterior		Revisión del 20:04 18 ene 2022
Línea 6:		Línea 6:

	==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, 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>

			{{COVID Remdesivir}}

	==Pediatric Dosing==		==Pediatric Dosing==

Rossdonaldson1: /* COVID */

2021-01-16T12:31:57Z

COVID

← Revisión anterior		Revisión del 12:31 16 ene 2021
Línea 13:		Línea 13:

	===[[COVID]]===		===[[COVID]]===
	*~~The safety and effectiveness of remdesivir for the treatment of COVID-19 have~~ 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>		*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>
	*~~Remdesivir 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>		*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>		*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>

Rossdonaldson1 at 12:31, 16 January 2021

2021-01-16T12:31:01Z

← Revisión anterior		Revisión del 12:31 16 ene 2021
Línea 13:		Línea 13:

	===[[COVID]]===		===[[COVID]]===
	*The safety and effectiveness of remdesivir for the treatment of COVID-19 have not been evaluated in pediatric patients aged <12 years or weighing <40 kg.		*The safety and effectiveness of remdesivir for the treatment of COVID-19 have 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>
	*Remdesivir 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.		*Remdesivir 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).		*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==

Rossdonaldson1: /* Pediatric Dosing */

2021-01-16T12:30:36Z

Pediatric Dosing

← Revisión anterior		Revisión del 12:30 16 ene 2021
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	==Pediatric Dosing==		==Pediatric Dosing==
	*Not studied in pediatric patients		*Not studied in pediatric patients

			===[[COVID]]===
			*The safety and effectiveness of remdesivir for the treatment of COVID-19 have not been evaluated in pediatric patients aged <12 years or weighing <40 kg.
			*Remdesivir 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.
			*A clinical trial is currently evaluating the pharmacokinetics of remdesivir in children (ClinicalTrials.gov identifier NCT04431453).

	==Special Populations==		==Special Populations==

Rossdonaldson1: /* Special Populations */

2021-01-16T12:30:04Z

Special Populations

← Revisión anterior		Revisión del 12:30 16 ene 2021
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	==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===

Ihearttroponin at 12:12, 22 March 2020

2020-03-22T12:12:49Z

← Revisión anterior		Revisión del 12:12 22 mar 2020
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	==Pharmacology==		==Pharmacology==
	*Half-life:		*Half-life: Unknown
	*Metabolism:		*Metabolism: Unknown
	*Excretion:		*Excretion: Unknown

	==Mechanism of Action==		==Mechanism of Action==
			*Adenosine nucleotide analog that interferes with the action of viral RNA polymerase, resulting in decreased virus production<ref> 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.</ref>

	==Comments==		==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.<ref>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</ref>

	==See Also==		==See Also==
			*[[Coronavirus]]
			*[[COVID-19]]

	==References==		==References==

Ihearttroponin at 23:04, 21 March 2020

2020-03-21T23:04:55Z

← Revisión anterior		Revisión del 23:04 21 mar 2020
Línea 6:		Línea 6:

	==Adult Dosing==		==Adult Dosing==
			*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>

	==Pediatric Dosing==		==Pediatric Dosing==
			*Not studied in pediatric patients

	==Special Populations==		==Special Populations==
	===[[Drug pregnancy categories\|Pregnancy Rating]]===		===[[Drug pregnancy categories\|Pregnancy Rating]]===
	*		*No data

	===Lactation risk===		===Lactation risk===
	*		*No data

	===Renal Dosing===		===Renal Dosing===
	*Adult:		*Adult: Unknown
	*Pediatric:		*Pediatric: Unknown

	===Hepatic Dosing===		===Hepatic Dosing===
	*Adult:		*Adult: Unknown
	*Pediatric:		*Pediatric: Unknown

	==Contraindications==		==Contraindications==
Línea 31:		Línea 32:
	==Adverse Reactions==		==Adverse Reactions==
	===Serious===		===Serious===
			*Unknown

	===Common===		===Common===
			*Unknown

	==Pharmacology==		==Pharmacology==

Ihearttroponin: /* Administration */

2020-03-21T22:53:46Z

Administration

← Revisión anterior		Revisión del 22:53 21 mar 2020
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	==Administration==		==Administration==
	*Type:		*Type: [[Antiviral]]
	*Dosage Forms:		*Dosage Forms: 100 mg, 200 mg
	*Routes of Administration:		*Routes of Administration: IV
	*Common Trade Names:		*Common Trade Names: N/a

	==Adult Dosing==		==Adult Dosing==