COVID-19:
Hospitalized patients:
Note: In general, guidelines recommend use in conjunction with dexamethasone (Ref); may be used as monotherapy in select patients (eg, requiring minimal conventional oxygen, not requiring oxygen supplementation but at high risk of severe COVID-19) (Ref).
IV: 200 mg as a single dose on day 1, followed by 100 mg once daily. Duration is generally 5 days or until hospital discharge, whichever is first, but may extend to up to 10 days based on clinical response (Ref). Initiate as soon as possible after the diagnosis of symptomatic COVID-19 (Ref).
Nonhospitalized patients with high risk of progression to severe illness:
IV: 200 mg as a single dose on day 1, followed by 100 mg once daily on days 2 and 3. Initiate as soon as possible after COVID-19 diagnosis and within 7 days of symptom onset (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: The remdesivir formulations contain the excipient sulfobutylether-beta-cyclodextrin (SBECD), with the injection solution containing 6 g per 100 mg remdesivir and the lyophilized powder containing 3 g per 100 mg remdesivir. SBECD accumulates in patients with kidney dysfunction, although the clinical significance of this accumulation is not certain (Ref). SBECD is dialyzable (46% removed by an ~4-hour dialysis session) (Ref).
eGFR ≥30 mL/minute: No dosage adjustment necessary.
eGFR <30 mL/minute: No formal safety or pharmacokinetic data are available for patients with kidney impairment or who are receiving renal replacement therapies (Ref). Manufacturer’s labeling does not recommend use; however, significant toxicity with a short duration of therapy (eg, 5 to 10 days) is unlikely (Ref). Benefits may outweigh the risks in select patients (Ref). In 4 small retrospective reviews of patients with chronic or acute kidney impairment (3 that included patients receiving dialysis), remdesivir, given at the recommended dose, did not routinely increase serum creatinine or cause severe hepatic toxicity (ALT >5 times the normal limit) (Ref).
In a pharmacokinetic observation of a single patient receiving intermittent hemodialysis and a 5-day course of remdesivir, remdesivir’s predominant metabolite, GS-441524, reached high but stable concentrations, with dialysis reducing concentrations by ~50%, thus preventing accumulation (Ref). Another observational study of 3 patients with end-stage kidney disease receiving hemodialysis who received 5-day courses of remdesivir reported similarly elevated concentrations of GS-441524; hemodialysis reduced concentrations by 45% to 49% (Ref).
Baseline hepatic impairment: There are no dosage adjustments provided in the manufacturers labeling (has not been studied).
Hepatoxicity during therapy:
ALT >10 times the ULN: Consider remdesivir discontinuation.
ALT elevation AND signs or symptoms of liver inflammation: Discontinue remdesivir.
(For additional information see "Remdesivir: Pediatric drug information")
COVID-19, hospitalized patients; treatment: Note: Initiate as soon as possible after diagnosis of symptomatic COVID-19. Duration is generally 5 days or until hospital discharge, whichever is first, but may be extended up to 10 days if patient does not clinically improve or requires extracorporeal membrane oxygenation or mechanical ventilation (Ref).
Infants ≥3 kg, Children, and Adolescents:
3 to <40 kg: Lyophilized powder only: IV: Loading dose: 5 mg/kg/dose on day 1, followed by 2.5 mg/kg/dose once daily (Ref).
≥40 kg: Injection solution or lyophilized powder: IV: Loading dose: 200 mg on day 1, followed by 100 mg once daily (Ref).
COVID-19, nonhospitalized patients; treatment: Note: Reserve for the treatment of mild to moderate COVID-19 in patients at high risk for progression to severe disease, including hospitalization or death; refer to the CDC for more information on patients at high risk for progression to severe disease. Initiate as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset (Ref).
Infants ≥3 kg, Children, and Adolescents:
3 to <40 kg: Lyophilized powder only: IV: Loading dose: 5 mg/kg/dose on day 1, followed by 2.5 mg/kg/dose once daily on days 2 and 3 (Ref).
≥40 kg: Injection solution or lyophilized powder: IV: Loading dose: 200 mg on day 1, followed by 100 mg once daily on days 2 and 3 (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Note: Remdesivir contains the excipient sulfobutylether-beta-cyclodextrin (SBECD), which accumulates in patients with kidney dysfunction, although the clinical significance of this accumulation is not certain (Ref). The injection solution contains 6 g of SBECD per 100 mg remdesivir; the lyophilized powder contains 3 g of SBECD per 100 mg remdesivir. SBECD is dialyzable (46% removed by an ~4-hour dialysis session) (Ref).
Infants ≥3 kg, Children, and Adolescents (Ref):
eGFR ≥30 mL/minute: No dosage adjustment recommended.
eGFR <30 mL/minute: No formal safety or pharmacokinetic data are available for patients with kidney impairment or who are receiving renal replacement therapies (Ref). Use is not recommended by the manufacturer. However, significant toxicity with a short duration of therapy (eg, 5 to 10 days) is unlikely; benefits may outweigh the risks in select patients (Ref). In retrospective studies in adult patients with acute or chronic kidney impairment, remdesivir administered at the recommended dose has not been shown to routinely increase serum creatinine or cause severe hepatic toxicity (ALT >5 times the normal limit) (Ref).
In a pharmacokinetic observation of a single adult patient receiving intermittent hemodialysis and a 5-day course of remdesivir, remdesivir's predominant metabolite, GS-441524, reached high but stable concentrations. Dialysis reduced concentrations by ~50%, thus preventing accumulation (Ref). Another observational study of 3 adult patients with end-stage kidney disease receiving hemodialysis who received 5-day courses of remdesivir reported similarly elevated concentrations of GS-441524; hemodialysis reduced concentrations by 45% to 49% (Ref).
Infants ≥3 kg, Children, and Adolescents (Ref):
Baseline hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Hepatotoxicity during therapy:
ALT >10 times the ULN and asymptomatic: Consider discontinuing remdesivir.
ALT elevation AND signs or symptoms of liver inflammation: Discontinue remdesivir.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Veklury: 100 mg/20 mL (20 mL [DSC])
Solution Reconstituted, Intravenous:
Generic: 100 mg (1 ea [DSC]); 150 mg (1 ea [DSC])
Solution Reconstituted, Intravenous [preservative free]:
Veklury: 100 mg (1 ea)
Generic: 100 mg (1 ea)
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Veklury: 100 mg/20 mL ([DSC])
Solution Reconstituted, Intravenous:
Veklury: 100 mg (1 ea)
Remdesivir is available to hospitals directly from the distributor AmerisourceBergen (1-800-746-6273 or remdesivir@amerisourcebergen.com); more information is available at https://www.vekluryhcp.com/product-access/. Additionally, health care providers must track and report all medication errors and serious adverse events potentially associated with remdesivir use by either submitting a MedWatch form (https://www.fda.gov/medwatch/report.htm) or FDA Form 3500 (health professional) by fax (1-800-FDA-0178); a copy of all MedWatch forms should also be provided to Gilead (safety_fc@gilead.com).
IV: Administer as an IV infusion over 30 to 120 minutes. May be an irritant; avoid extravasation (Ref).
Parenteral: IV: Administer as an IV infusion over 30 to 120 minutes in a setting where it is possible to appropriately manage severe hypersensitivity reactions (such as anaphylaxis). Do not administer simultaneously with any other medication or IV solutions other than NS (Ref). May be an irritant; avoid extravasation (Ref).
COVID-19: Treatment of laboratory-confirmed COVID-19 in adult and pediatric patients (28 days of age and older weighing at least 3 kg) who require hospitalization or nonhospitalized patients with mild to moderate COVID-19 at high risk for progression to severe COVID-19, including hospitalization or death. Remdesivir may only be administered in health care settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary.
Remdesivir (Veklury) is available in two formulations for IV administration, a concentrated solution and a lyophilized powder. Each product has different recommendations for storage, preparation for administration, and administration. In addition, the concentrated solution should only be used in adults and pediatric patients weighing ≥40 kg, while the lyophilized powder can be used in adults and pediatric patients weighing ≥3 kg. The Institute for Safe Medication Practices (ISMP) reports that there have been numerous medication errors related to the two formulations available; use caution with product selection and follow appropriate recommendations for the formulation (FDA 2022; ISMP 2020).
Postmarketing reports of bradycardia, including severe bradycardia (some fatal) and sinus bradycardia, have been reported in patients receiving remdesivir for COVID-19. An observational study using data from the WHO pharmacovigilance database found that bradycardia was more likely to be reported with remdesivir treatment than with hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or glucocorticoid treatment, and reports included mostly males in the United States over a wide spectrum of ages (43 to 79 years of age). Most of these patients were not receiving concurrent cardiovascular medications. Other cardiac effects were observed, most notably hypotension (Ref).
Mechanism: Unknown; it has been suggested that the active metabolite of remdesivir, a nucleotide triphosphate derivative, may slow sinoatrial node automaticity due to its similarity with adenosine triphosphate (Ref).
Onset: Bradycardia: Varied; a median onset of 2.4 days (range: 1 to 6 days) was observed in an observational study (Ref). Other reports have noted onset of bradycardia within 24 hours of administration of first dose (Ref).
Mild to moderate (grades 1 to 2), reversible transaminase elevations, including increased serum alanine aminotransferase and increased serum aspartate aminotransferase, have been observed in healthy volunteers and adult and pediatric patients with COVID-19. It is unclear if these effects are drug-related or related to COVID-19. Most aminotransferase elevations during treatment for COVID-19 were reversible and not associated with jaundice; cases with jaundice rarely occurred, typically in patients with other risk factors for liver toxicity (Ref).
Hypersensitivity reactions, including anaphylaxis and infusion related reactions, have been reported during and following remdesivir administration. Patients may experience angioedema, bradycardia, diaphoresis, dyspnea, fever, hypertension, hypotension, hypoxia, nausea, shivering, skin rash, tachycardia, and wheezing. Slower infusion rates (maximum infusion time of up to 120 minutes) may be considered in patients to potentially prevent hypersensitivity or infusion related reactions.
Onset: Rapid; most commonly occurs within 1 hour.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adolescents and adults.
>10%:
Endocrine & metabolic: Increased serum glucose (grades 3/4: 3% to 11%)
Renal: Decreased creatinine clearance (grades 3/4: 2% to 19%), increased serum creatinine (grades 3/4: 3% to 15%)
1% to 10%:
Dermatologic: Skin rash (<2%)
Gastrointestinal: Nausea (3% to 7%)
Hematologic & oncologic: Decreased hemoglobin (grades 3/4: 1% to 8%), lymphocytopenia (grades 3/4: 2%), prolonged prothrombin time (grades 3/4: 9%) (table 1)
Drug (Remdesivir) |
Placebo |
Dose |
Indication |
Number of Patients (Remdesivir) |
Number of Patients (Placebo) |
---|---|---|---|---|---|
Grades 3/4: 9% |
4% |
200 mg on Day 1 and 100 mg once daily on subsequent days, for 10 days of treatment |
SARS-CoV-2 infection |
532 |
516 |
Hepatic: Increased serum alanine aminotransferase (2% to 7%), increased serum aspartate aminotransferase (3% to 6%)
Hypersensitivity: Hypersensitivity reaction (<2%)
Nervous system: Seizure (<2%)
Frequency not defined:
Hepatic: Increased serum alkaline phosphatase
Hypersensitivity: Angioedema, infusion-related reaction
Local: Erythema at injection site
Postmarketing:
Cardiovascular: Bradycardia (including severe bradycardia and sinus bradycardia) (Gubitosa 2020, Jacinto 2021, Touafchia 2021), heart failure (Wang 2020), hypotension (Touafchia 2021)
Hepatic: Acute hepatic failure (Carothers 2020)
Hypersensitivity: Anaphylaxis (Hopkins 2021)
Hypersensitivity to remdesivir or any component of the formulation.
Disease-related concerns:
• Renal impairment: Use caution in patients with eGFR <30 mL/minute and assess risk versus benefit based upon dosing information in renal impairment.
Dosage form specific issues:
• Injection: Contains the excipient cyclodextrin (sulfobutylether-beta-cyclodextrin [SBECD]; 6 g per 100 mg remdesivir [injection solution] or 3 g per 100 mg remdesivir [lyophilized powder]), which may accumulate in patients with renal impairment.
Sulfobutylether-beta-cyclodextrin sodium salt (SBECD) is an excipient in remdesivir; SBECD is renally cleared and accumulates in patients with decreased renal function. The lyophilized powder formulation contains 3 g of SBECD per 100 mg remdesivir, while the injection solution 5 mg/mL contains 6 g of SBECD per 100 mg remdesivir. In pediatric patients weighing <40 kg, the manufacturer recommends use of the lyophilized powder only.
Substrate of CYP2C8 (minor), CYP2D6 (minor), CYP3A4 (minor), OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Chloroquine: May diminish the therapeutic effect of Remdesivir. Risk X: Avoid combination
Hydroxychloroquine: May diminish the therapeutic effect of Remdesivir. Risk X: Avoid combination
Warfarin: Remdesivir may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy
Information related to use of remdesivir in pregnant patients is available from small studies and case reports (Budi 2022; Burwick 2021; Eid 2022; Jorgensen 2021; Nasrallah 2021). Based on available data, use is well tolerated (NIH 2022) and early administration improves clinical outcomes in pregnant patients (Eid 2022).
• Outcome data are available from pregnant (n = 67) and postpartum (n = 19) patients who received remdesivir through the compassionate use program:
- COVID-19 was confirmed in all cases, and all patients had an oxygen saturation ≤94% on room air or required oxygen support. Dosing was the same as nonpregnant adults. Exposure occurred <24 weeks' gestation (n = 12), 24 to 32 weeks' gestation (n = 44), >32 weeks' gestation (n = 11), or within 3 days postpartum (delivery between 24 and 32 weeks' gestation [n = 13]; delivery >32 weeks' gestation [n = 5]). Sixty-four percent of women had a comorbid medical condition that classified their pregnancy as high risk (obesity 17%, asthma 12%, gestational diabetes 10%, chronic hypertension 8%, diabetes mellitus 8%).
- In patients given remdesivir, 93% treated during pregnancy and 89% treated postpartum recovered within 28 days. Recovery was defined as discharge from hospital if on room air at baseline, return to room air or discharge if oxygen previously needed, or extubation if previously ventilated. Women not requiring ventilation had a median time to recovery of 5 days.
- Adverse effects were similar to those in nonpregnant patients; remdesivir was discontinued in 7 pregnant patients (10%) due to adverse events, most commonly due to an increase in liver enzymes (n = 5). Based on this preliminary data, maternal treatment with remdesivir during pregnancy had a high rate of recovery (Burwick 2021).
• A smaller study demonstrated the benefits of remdesivir treatment for pregnant patients hospitalized with moderate COVID-19:
- The study included 35 women (median gestation age 29.2 weeks) with moderate infection, defined as lower respiratory disease diagnosed by imaging or clinical assessment (abnormal blood gas, dyspnea, fever ≥39.0°C (102.2°F) not relieved with acetaminophen, pneumonia) and oxygen saturation on ambient air ≥94%. All patients in the study were managed with oral or IV corticosteroids and antibiotics when appropriate.
- Clinical recovery was defined as breathing on ambient air and/or hospital discharge on hospital day 7. A 5-day course of remdesivir led to clinical recovery in all patients (n = 17) when treatment was started within 48 hours of admission and in no patients when remdesivir was initiated >48 hours from admission (n = 7). Eleven pregnant patients were not treated with remdesivir; 3 progressed to severe disease and 8 required supplemental oxygen on hospital day 7.
- Oligohydramnios was diagnosed in 3 women within 5 days of their last remdesivir dose and in none of the women who did not receive remdesivir. Patients diagnosed with oligohydramnios did not have known risk factors and it is unclear if this finding was related to treatment, COVID-19 infection, or idiopathic. Amniotic fluid monitoring is recommended (Nasrallah 2021).
• A retrospective cohort study evaluated use of remdesivir to prevent ICU admission in hospitalized pregnant patients diagnosed with COVID-19 infection. Patients who received remdesivir within 7 days of symptoms (n = 24) were compared to those who received treatment ≥7 days from symptom onset (n = 17). None of the patients in this study had previously received a COVID-19 vaccine. Patients who received early remdesivir treatment were less likely to be admitted to the ICU, progress to critical disease, and had shorter hospital stays (Eid 2022).
The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID-19. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2022; NIH 2022).
In general, the treatment of COVID-19 infection during pregnancy is the same as in nonpregnant patients. Use of remdesivir should not be withheld if otherwise needed (NIH 2022). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
Data collection to monitor maternal and infant outcomes following exposure to remdesivir during pregnancy is ongoing.
- Pregnant and recently pregnant patients exposed to remdesivir are encouraged to enroll in the registry (800-616-3791 or http://covidpr.pregistry.com)
- Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (877-311-8972; https://mothertobaby.org/join-study/).
Remdesivir and the GS-441524 metabolite have been detected in breast milk.
Breast milk concentrations of remdesivir were evaluated in a patient diagnosed with COVID-19 infection 2 days following delivery at 38 weeks' gestation. Remdesivir 200 mg IV was administered on the first day, followed by 100 mg daily for 4 days. The mother had initiated breastfeeding prior to diagnosis and pumped to maintain the milk supply during remdesivir treatment. Breast milk was sampled on treatment day 5 prior to and 1, 3, 6, and 24 hours after remdesivir administration. Concentrations of remdesivir were measurable only in the sample obtained 1 hour prior to administration (1.29 ng/mL; corresponding maternal serum concentration 14.4 ng/mL). Concentrations of the GS-441524 metabolite in breast milk prior to and 24 hours after dosing were 13.5 ng/mL and 64.34 ng/mL; corresponding maternal serum concentrations were 389.9 ng/mL and 201.1 ng/mL, respectively. Metabolite concentrations in breast milk ranged from 13.5 ng/mL to 284.9 ng/mL. The half-life of GS-441524 in breast milk was 9.3 hours. Authors of the study calculated the relative infant dose (RID) of remdesivir to be <1% and the RID of GS-441524 to be 1.55%, concentrations considered acceptable for breastfeeding (Wada 2022).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breast milk has not been found to contain infectious materials from SARS-CoV-2 and maternal infection is not a contraindication to breastfeeding. However, lactating patients with COVID-19 infection should take all precautions to avoid spreading the virus to the infant (eg, hand hygiene, mask wearing, etc) and the infant should be isolated with the mother; alternately, breast milk can be expressed and fed to the infant by someone without confirmed or suspected COVID-19 (ACOG 2022).
Interim guidance is available from the Centers for Disease Control and Prevention for the care of lactating patients who are diagnosed with coronavirus disease 2019 (COVID-19) (https://www.cdc.gov/coronavirus/2019-ncov/hcp/care-for-breastfeeding-women.html). Information related to COVID-19 and breastfeeding is also available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).
Baseline and during remdesivir administration when clinically appropriate: Heart rate (Touafchia 2021); hepatic function tests (ALT, AST, bilirubin, alkaline phosphatase, prothrombin time); renal function tests (serum creatinine, CrCl); signs/symptoms of infusion reaction.
Monitor patients during infusion and observe patients for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate.
Remdesivir is an inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp), which is essential for viral replication. Remdesivir is an adenosine nucleotide prodrug that is metabolized to the pharmacologically active nucleoside triphosphate metabolite after being distributed into cells. Remdesivir triphosphate (GS-443902) acts as an adenosine triphosphate analog and competes for incorporation into RNA chains by the SARS-CoV-2 RdRp, resulting in delayed chain termination during viral RNA replication. Remdesivir triphosphate can also inhibit viral RNA synthesis due to incorporation into the viral RNA template.
Protein binding: Remdesivir: 88% to 93.6%; GS-441524: 2%; GS-704277: 1%.
Half-life elimination: Remdesivir: ~1 hour; GS-441524: 27 hours; GS-704277: 1.3 hours.
Excretion:
Urine: Remdesivir: 10%; GS-441524: 49%; GS-704277: 2.9%
Feces: Remdesivir: Not detected; GS-441524: 0.5%; GS-704277: Not detected.
Expected drug exposure in adults with normal renal function:
Cmax (peak): IV: 100 mg once daily, steady state: Remdesivir: 2,229 ng/mL; GS-441524: 145 ng/mL; GS-704277: 246 ng/mL.
Cmin (trough): IV: 100 mg once daily, steady state: Remdesivir: Not detected; GS-441524: 69.2 ng/mL; GS-704277: Not detected.
AUC: IV: 100 mg once daily, steady state: Remdesivir: 1,585 ng • hour/mL; GS-441524: 2,229 ng • hour/mL; GS-704277: 462 ng • hour/mL.
Pediatric: In a pharmacokinetic modeling study, exposure to remdesivir and metabolites (Cmax, AUC) was higher in pediatric patients ≥28 days of age weighing ≥3 kg receiving recommended dosing regimens as compared to adults. The difference in exposure is not expected to be clinically significant.
Solution (reconstituted) (Remdesivir Intravenous)
100 mg (per each): $624.00
Solution (reconstituted) (Veklury Intravenous)
100 mg (per each): $624.00
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