Generic Medicine Info
Hypersensitivity. Baseline ALT ≥5 times the upper limit of normal (ULN). Severe renal impairment (eGFR <30 mL/min) including patients receiving renal replacement therapies (e.g. haemodialysis, peritoneal dialysis, CRRT).
Special Precautions
Not recommended for the treatment of mild or moderate COVID-19 outside of a clinical trial. Renal and hepatic impairment. Children. Pregnancy and lactation; use only if potential benefits justify potential risks as there is limited data regarding the use of remdesivir in pregnant and lactating women. Monitoring Parameters Perform LFT, and, haematology test at baseline and daily during therapy. Determine eGFR (in adult and children >28 days old) and serum creatinine (in full-term neonates 7-28 days old) prior to initiation and daily during therapy. It should be noted that: - Remdesivir for the treatment of COVID-19 have not been definitely established, some data are available from several initial trials in the US and other countries. - Remdesivir may be available for use in some countries under special agreement with manufacturer. Please refer to local regulatory agencies for relevant information. The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery. - There is still lack of evidence to support the use of remdesivir empirically prior to confirmation of COVID-19, mild to moderate cases of COVID-19, pre- and post-exposure prophylaxis outside of clinical trial setting. On-going clinical trials hope to shed some light in these areas soon. For healthcare professionals: - Read the most up-to-date fact sheet when prescribing remdesivir. - No specific drug-drug interaction data are available. Minimise any unnecessary co-medication whenever possible given lack of information about interaction risk. - To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations for administration of remdesivir. Please refer to respective local regulatory agencies for further information.
Adverse Reactions
Significant: Increased transaminase levels; infusion-related and anaphylactic reactions, including angioedema, diaphoresis, dyspnoea, bradycardia or tachycardia, hypotension, nausea, rash, shivering, vomiting, wheezing. Blood and lymphatic system disorders: Anaemia. General disorders and administration site conditions: Pyrexia. Investigations: Increased blood glucose, decreased Hb. Metabolism and nutrition disorders: Hyperglycaemia. Nervous system disorders: Headache. Renal and urinary disorders: Increased serum creatinine, decreased eGFR or CrCl, acute kidney injury.
Drug Interactions
Diminished therapeutic effect with chloroquine or hydroxychloroquine.
CIMS Class
Disclaimer: This information is independently developed by CIMS based on remdesivir from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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