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SA Health 

 
 

 
 
 
 

Remdesivir  
Drug Monograph 

 
 
 

  
 
 
 
 
 
 
 
 
 
 

 
 

Version 3.0 

 

Approval date:  12/04/22 

 
  



 
 

Remdesivir Drug Monograph 
 

1. Remdesivir drug monograph 
 

Remdesivir1,4,13 

ID approval and patient consent (verbal or written) required 
For the most recent updates on the use of remdesivir in patients with COVID-19 infections visit the Remdesivir drug 

guideline available via the NSW Therapeutic Advisory Group 

Drug Class o Antiviral, a nucleotide analogue prodrug that binds to the viral RNA-dependent RNA 

polymerase and inhibits viral replication through premature termination of RNA 

transcription. 

Indications 
 

? Second line treatment (when nirmatrelvir plus ritonavir is not suitable) of mild COVID-
19 for non-pregnant adult patients who do not require supplemental oxygen and are 
within 7 days of symptom onset  

AND 
are immunosuppressed irrespective of vaccination status 
OR 

? are not vaccinated and age ? 65 years (? 50 years if Aboriginal and/or Torres 
Strait Islander) and two or more risk factors for progressing to severe illness 

? Treatment of breastfeeding or pregnant women in their second or third trimester within 
7 days of symptom onset and do not require supplemental oxygen AND: 

? are Immunosuppressed irrespective of vaccine status 
OR 

? who have reduced immunity to COVID-19 e.g. not vaccinated or do not have an 
up-to-date vaccine status AND who have one or more risk factors for progressing 
to severe or critical illness. 

Contra-indications  ? Known hypersensitivity to any ingredient of remdesivir product or remdesivir 

metabolites.  

? Mechanical ventilation for &gt;48 hours at the time of commencement 

? Renal impairment1: eGFR &lt; 30mL/min/1.73m2 (contact ID to discuss risk vs benefit) 

? Formulated with the excipient sulfobutyl betadex sodium (SBECD) which 

accumulates in renal impairment  

? For patients on dialysis please seek specialist advice as SBECD is cleared to 

varying degrees depending on the type of dialysis  

? Hepatic impairment: ALT ? 5 times the upper normal limit (ULN) at baseline 

? Patients with evidence of multiorgan failure, including coagulopathy (significant 

thrombocytopenia), hepatic failure, renal failure or significant cardiomyopathy are not 

eligible to access remdesivir from the National Medicines Stockpile 

                                                      
 
 
 
 
 
 
 
1 NOTE: Dose adjustments are based on eGFR (CKD-EPI). For patients with extremes of body size, 
multiply the eGFR by the patient s body surface area (in m2) and divide by 1.73 m2 




 
 

INFORMAL COPY WHEN PRINTED Remdesivir Drug Monograph 

 OFFICIAL Page 3 of 6 

Precautions  ? Factors where the benefit of remdesivir is uncertain &amp; requires careful consideration 

before use:  

o Presence of an intercurrent illness likely to lead to the patient s death within one 

year; 

o Advanced age with limitations on activities of daily living;  

o Need for more than a 5 day treatment course (not available via NMS) 

Drug Interactions ? Drug-drug interaction trials of remdesivir and other concomitant medications have not 

been conducted in humans. Remdesivir is a substrate for several drug metabolising 

enzymes however clinical relevance of these interactions has not been established 

? Use with hydroxychloroquine or chloroquine is not recommended as it may result in 

reduced antiviral activity of remdesivir 

? For detailed information regarding drug interactions with remdesivir please check the 

University of Liverpool COVID-19 resource page 

Preparation ? There are 2 preparations available in Australia via the NMS 

o Powder for Injection 

? 100 mg sterile, preservative-free, white to off-white to yellow lyophilised 

powder vial.  

? Requires storage below 30 C.  

? Contains sulfobutyl betadex sodium (SBECD 3 g), hydrochloric acid &amp; 

sodium hydroxide.  

o Concentrated solution vial 

? 100 mg/20 mL concentrate solution (clear colourless to yellow) vial; sterile 

preservative-free.  

? Requires refrigerated storage at 2 8 C.  

? Stable for up to 12 hours at room temperature (20 25 C) prior to dilution.  

? Contains sulfobutyl betadex sodium (SBECD 6 g), hydrochloric acid &amp; 

sodium hydroxide.  

? Concentrated solution not recommended in children &lt; 12 years of age 

or adolescents weighing &lt;40kg 

Dose ? Mild illness: 200mg via intravenous infusion on day 1, then 100mg IV daily for a further 

2 days (total 3 days treatment) 

? Moderate to critical illness: 200mg via intravenous infusion on day 1, then 100mg IV 

daily for a further 4 days (total 5 days treatment only per NMS) 

Administration ? There are different formulations of remdesivir available via the National Medicines 

Stockpile and administration instructions may vary.  

? For administration details please refer either to the Australian Injectables Drugs 

Handbook and the NSW Therapeutic Advisory Group page on remdesivir.  

Monitoring  ? As experience with remdesivir at these doses and for this duration is limited patients 

should have appropriate clinical and laboratory monitoring including: 

o Baseline and day 1 and 3 creatinine, electrolytes, urea, LFTs and complete 

blood exam   

? Discontinue remdesivir if: 

? eGFR &lt; 30mL/min/m2 (contact ID to discuss risk vs benefit) 

? ALT ? 5 times ULN during treatment with remdesivir (remdesivir may be 

restarted when ALT is &lt; 5 times ULN) OR 

? ALT elevation accompanied by signs or symptoms of liver inflammation 

or increasing conjugated bilirubin, alkaline phosphatase, or INR. 

o Perform baseline and DAILY coagulation profile testing, including prothrombin 

time 

o Heart rate 







 
 

INFORMAL COPY WHEN PRINTED Remdesivir Drug Monograph 

 OFFICIAL Page 4 of 6 

o Observe for infusion-related reactions. If present, immediately discontinue 

Adverse Effects ? As experience with remdesivir at these doses and for this duration is limited patients it is 

important to document and report all suspected adverse effects. To date the following 

adverse effects have been observed: 

o Very common (&gt;10%):  graded elevations in ALT, AST and bilirubin 

o Common (&gt;1%): prolonged prothrombin time, gastrointestinal symptoms (e.g. 

nausea, vomiting, diarrhoea), headache, rash 

o Rare (&lt;0.1%): hypersensitivity reactions (anaphylactic reactions are rare but are 

a medical emergency; stop the infusion and begin treatment immediately) 

? Infusion-related reactions may include hypotension, nausea, vomiting, diaphoresis, 

shivering 

? Post-marketing adverse effects reported include bradycardia (including severe 

bradycardia and sinus bradycardia), cardiac failure and hypotension 

? Suspected or confirmed adverse reactions should be reported via Safety Learning 

System and also via the Therapeutic Goods Administrations adverse effects online 

form: TGA adverse event reporting 

Patient 
information and 
consent forms 

? Remdesivir patient information leaflets are available via the NSW Therapeutic Advisory 

Group  

? Example patient consent forms can be found here 

 

2. Definitions/acronyms/abbreviations 

BMI  Body Mass Index 

COPD Chronic obstructive pulmonary disease  

eGFR estimated Glomerular Filtration Rate 

GI Gastrointestinal 

HBV Hepatitis B virus 

HCV Hepatitis C virus 

HIV Human Immunodeficiency Virus  

ID Infectious Diseases 

IV Intravenous 

LFTs Liver function tests 

NMS National Medical Stockpile 

NYHA New York Heart Association 

 

2 Resources 

? National COVID-19 Clinical Evidence Taskforce (The Australian Living Guidelines) 

? COVID-19 Resources: NSW Therapeutic Advisory Group 

? COVID 19 (SARS COV 2)   Management Guide (CALHN PRC05409) 

? Anaphylaxis: Management Guidelines (CALHN-OWI04038) 

? COVID-19: Disease-modifying therapy recommendations for hospitalised adults (CALHN-
GDE05778) 

? CALHN COVID 19 internet page 

? World Health Organisation. Therapeutics and COVID-19: Living Guideline 














 
 

INFORMAL COPY WHEN PRINTED Remdesivir Drug Monograph 

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? Australian Technical Advisory Group on Immunisation (ATAGI) 

? Clinical Excellence Commission: Medication Safety Updates 

? COVID-19 Treatment: Nirmatrelvir-Ritonavir (Paxlovid ) (IH-CIS05842) 

? COVID-19 Resources: Medicines Use in the treatment of COVID-19   Consent Forms 

 

3 References 
 

1. National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people 
with COVID-19. https://covid19evidence.net.au/#living-guidelines . Published 2022 (v55.0). Accessed 
April 2022.  

2. NSW Therapeutic Advisory Group Inc. COVID-19 Resources: Medicine use in the treatment of 
COVID-19. https://www.nswtag.org.au/covid-19-medicines-resources/. Published 2021. Accessed 
2021 October 

3. Therapeutic Goods Administration   Xevudy (Sotrovimab). TGA; 2021. 
https://www.tga.gov.au/auspar/auspar-sotrovimab. Published 20th August 2021, Accessed October 
2021 

4. Society of Hospital Pharmacists of Australia. Australian Injectable Drugs Handbook (online). In:8th ed. 
Collingwood: Society of Hospital Pharmacists of Australia;2021: 
https://aidh.hcn.com.au/browse/s/sotrovimab. Accessed October 2021 

5. National Institutes of Health. Corticosteroids 2021. 
https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/corticosteroids/#:~:text=
Patients%20with%20severe%20COVID%2D19,or%20mitigate%20these%20deleterious%20effects. 
Accessed October 2021 

6. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients 
with COVID-19. 2020. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-
management/. Accessed October 2021 

7. Liverpool Drug Interactions Group. Interaction Checker. https://www.covid19-
druginteractions.org/checker. Accessed Feb 2022 

8. Australian Medicines Handbook Pty Ltd; 2021. https://amhonline.amh.net.au/. Accessed October 2021 
9. World Health Organisation. Therapeutics and COVID-19: Living Guideline. 

https://www.who.int/publications/i/item/WHO-2019-nCoV-therapeutics-2021.3. Accessed October 
2021 

10. Centers for Disease Control and Prevention. Interim Clinical Considerations for Use of COVID-19 
Vaccines Currently Authorized in the United States. CDC. https://www.cdc.gov/vaccines/covid-
19/downloads/clinical-considerations-slides-for-hcp.pptx Updated 2021 September. Accessed 2021 
October 2021. 

11. National Asthma Council of Australia. https://www.nationalasthma.org.au/. Accessed Nov 2021 
12. Clinical Excellence Commission. Medication Safety Updates. 

https://www.cec.health.nsw.gov.au/keep-patients-safe/medication-safety/medicine-updates  Accessed 
March 2022 

13. Bernal AJ et al.  Molnupiravir for oral treatment of Covid-19 in non-hospitalised patients (MOVe-OUT). 
NEJM. December 16, 2021. DOI: 10.1056/NEJMoa2116044 

14. Evaluation of Protease Inhibition for COVID-19 in High-Risk patients (EPIC-HR study). Study of oral 
PF-07321332/ritonavir compared with placebo in non-hospitalised high risk adults with COVID-19. 
https://clinicaltrials.gov/ct2/show/NCT04960202. Accessed 1/2/2022. 

15. Therapeutic Goods Administration   Paxlovid TGA; 2022. https://www.tga.gov.au/apm-
summary/paxlovid Published 21st Jan 2022, Feb 2022 

16. Therapeutic Goods Administration   Molnupiravir TGA; 2022. https://www.tga.gov.au/apm-
summary/molnupiravir. Published 21st Jan 2022, Feb 2022 

17. UK Interim Clinical Commissioning Policy: therapies for symptomatic non-hospitalised patients with 
COVID-19. Version 1. Published 27th Jan 2022 

18. Centres for Disease Control and Prevention. Underlying Medical Conditions Associated with Higher 
Risk for Severe COVID-19: Information for Healthcare Providers. CDC. Underlying Medical Conditions 
Associated with Higher Risk for Severe COVID-19: Information for Healthcare Providers (cdc.gov). 
Updated 14th Oct 2021. Accessed Feb 2022 

19. Merck Sharp &amp; Dohme Medicines Information response Re: Administration of molnupiravir in patients 
who cannot swallow. Feb 11 2022 






























 
 

INFORMAL COPY WHEN PRINTED Remdesivir Drug Monograph 

 OFFICIAL Page 6 of 6 

20. Australian Technical Advisory Group on Immunisation (ATAGI). ATAGI statement on defining  up-to-
date  status for COVID-19 vaccination. https://www.health.gov.au/news/atagi-statement-on-defining-
up-to-date-status-for-covid-19-vaccination. Published Feb 10 2022. Accessed Feb 2022  

21. Australian Technical Advisory Group on Immunisation (ATAGI). ATAGI Recommendations on the use 
of a third primary dose of COVID-19 vaccine in individuals who are severely immunocompromised. 
https://www.health.gov.au/sites/default/files/documents/2022/03/atagi-recommendations-on-the-use-
of-a-third-primary-dose-of-covid-19-vaccine-in-individuals-who-are-severely-immunocompromised.pdf 
Published 25 March 2022. Accessed April 2022 

22. Takashita E et al. Efficacy of antiviral agents against the SARS-CoV-2 Omicron subvariant BA.2. 
NEJM letter. Published March 9 2022. 

5 Document Ownership 
 
Clinical Guideline owner:  CALHN Infectious Diseases via Office of the Chief Pharmacist 

Title: COVID-19: Medication Management of Mild Illness in the Outpatient Setting Clinical Guideline  

ISBN:  978-1-76083-509-5 

Objective reference number:   

Review date:  April 2025 

Contact for enquiries:  Health.CALHNAntimicrobialStewardship@sa.gov.au or 

Health.OfficeoftheChiefPharmacist@sa.gov.au 

 

6 Document History 
 

Version Date approved  Approved by Amendment notes 

3.0 12/04/22 CALHN Drug and Therapeutics 
Committee 

South Australian Medicines 
Advisory Committee 

Monograph updated to align with 
updated COVID-19: Medication 
management of Mild Illness in the 
Outpatient Setting Guideline v3.0 

2.0 

 

18/02/22 CALHN Drug and Therapeutics 
Committee 

COVID-19 Medicines Advisory 
Group 

Add molnupiravir and nirmatrelvir plus 
ritonavir.  Added link on sotrovimab 
monograph for breastfeeding advice. 

1.0 19/01/22 South Australian Medicines 
Advisory Committee 

New guideline to provide a pathway for 
the medication management of mild 
COVID-19 illness in the outpatient 
setting. 

 








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