Remdesivir


Thông tin thuốc gốc
Chỉ định và Liều dùng
Intravenous
Coronavirus disease 2019 (COVID-19)
Adult: Hospitalised patients: 200 mg as a single dose on Day 1, followed by 100 mg once daily starting on Day 2. Treatment duration: Patients not requiring mechanical ventilation/extracorporeal membrane oxygenation (ECMO): 5 days; may extend for up to 5 additional days (total of 10 days) in patients who do not demonstrate clinical improvement. Patients requiring invasive mechanical ventilation/ECMO: 10 days. Nonhospitalised patients with mild to moderate COVID-19 who are at high risk for progression to severe cases: 200 mg as a single dose on Day 1, followed by 100 mg once daily on Days 2 and 3. Treatment duration: 3 days. Initiate as soon as possible after diagnosis of symptomatic COVID-19. Doses are given via infusion over 30-120 minutes. Dosage recommendation is based on currently available data from clinical studies and may vary among local guidelines or countries.
Child: Hospitalised patients: ≥28 days weighing 3-<40 kg: As lyophilised powder: 5 mg/kg on Day 1, followed by 2.5 mg/kg once daily starting on Day 2; ≥40 kg: As lyophilised powder or concentrated solution: Same as adult dose. Treatment duration: Patients not requiring mechanical ventilation/ECMO: 5 days; may extend for up to 5 additional days (total of 10 days) in patients who do not demonstrate clinical improvement. Patients requiring invasive mechanical ventilation/ECMO: 10 days. Nonhospitalised patients with mild to moderate COVID-19 who are at high risk for progression to severe cases: ≥28 days weighing 3-<40 kg: As lyophilised powder: 5 mg/kg on Day 1, followed by 2.5 mg/kg once daily on Days 2 and 3; ≥40 kg: As lyophilised powder or concentrated solution: Same as adult dose. Treatment duration: 3 days. Doses are given via infusion over 30-120 minutes. Dosage recommendation is based on currently available data from clinical studies and may vary among local guidelines or countries.
Suy thận
eGFR <30 mL/min: Contraindicated.
Hướng dẫn pha thuốc
Lyophilised powder: Reconstitute with 19 mL of sterile water for injection and further dilute in an infusion bag containing 100 mL or 250 mL of NaCl 0.9% prior to administration. Solution for inj: Dilute solution in an infusion bag containing 250 mL of NaCl 0.9% prior to administration. Administer immediately after preparation.
Tương kỵ
Do not administer simultaneously with any other IV drugs.
Chống chỉ định
Hypersensitivity. Baseline ALT ≥5 times the upper limit of normal (ULN). Severe renal impairment (eGFR <30 mL/min).
Thận trọng
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.

It should be noted that:

- Remdesivir for the treatment of COVID-19 has 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 a 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 a more rapid time to recovery.

- There is still a 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 settings in some countries. On-going clinical trials hope to shed some light on these areas soon.

- Remdesivir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended.

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 the 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 the administration of remdesivir. Please refer to respective local regulatory agencies for further information.
Tác dụng không mong muốn
Significant: Increased transaminase levels; infusion-related and anaphylactic reactions, including angioedema, diaphoresis, dyspnoea, bradycardia or tachycardia, hypotension or hypertension, nausea, rash, fever, shivering, vomiting, wheezing; prolonged prothrombin time.
Investigations: Increased blood glucose and serum creatinine; decreased eGFR, Hb and lymphocytes.
Nervous system disorders: Headache, generalised seizure.
IV: Z (Current evidence has not identified any safety signals. Nevertheless, due to limited information, use only when benefits outweigh risks.)
Thông tin tư vấn bệnh nhân
Women of childbearing potential must use proven birth control methods during therapy.
Chỉ số theo dõi
Monitor heart rate, LFT, and renal function prior to initiation of therapy and during treatment as clinically appropriate. Observe for signs and symptoms of hypersensitivity reactions during infusion and for at least 1 hour after infusion is complete.
Tương tác
Chloroquine or hydroxychloroquine may reduce the antiviral activity of remdesivir.
Tác dụng
Description: Remdesivir is an adenosine nucleotide prodrug that is metabolised intracellularly to the pharmacologically active nucleoside triphosphate metabolite (GS-443902). Remdesivir triphosphate acts as an ATP analog and competes for incorporation into RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, resulting in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate may also inhibit viral RNA synthesis via incorporation into the viral RNA template.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 0.7 hour (remdesivir); 1.5-2 hours (GS-441524); 0.75 hour (GS-704277).
Distribution: Distributed to plasma or cellular components of blood. Plasma protein binding: 88-94% (remdesivir); 2% (GS-441524); 1% (GS-704277).
Metabolism: Extensively metabolised intracellularly to the pharmacologically active nucleoside analog triphosphate GS-443902. Undergoes hydrolysis by esterases forming the intermediate metabolite, GS-704277. Phosphoramidate cleavage followed by phosphorylation forms the active triphosphate, GS-443902 while dephosphorylation of all phosphorylated metabolites results in the formation of nucleoside metabolite GS-441524.
Excretion: Mainly via urine (74%; 49% as GS-441524, 2.9% as GS-704277, 10% as unchanged drug); faeces (18%). Elimination half-life: Approx 1 hour (remdesivir); 27 hours (GS-441524), 1.3 hours (GS-704277).
Đặc tính

Chemical Structure Image
Remdesivir

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 121304016, Remdesivir. https://pubchem.ncbi.nlm.nih.gov/compound/121304016. Accessed July 28, 2022.

Bảo quản
Unopened vial: Lyophilised powder: Store below 30°C. Solution for inj: Store between 2-8°C. Diluted solution: Store between 20-25°C (stable for up to 24 hours) or between 2-8°C (stable for up to 48 hours).
Phân loại MIMS
Thuốc kháng virus
Phân loại ATC
J05AB16 - remdesivir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Tài liệu tham khảo
Beigel JH, Tomashek KM, Dodd, LE et al. Remdesivir for the Treatment of Covid-19 - Preliminary Report. The New England Journal of Medicine. 2020 May. doi: 10.1056/NEJMoa2007764. Accessed 30/07/2020

Anon. Remdesivir. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 21/02/2022.

Anon. Remdesivir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/09/2022.

Buckingham R (ed). Remdesivir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 21/02/2022.

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children. U.S. FDA. https://www.fda.gov. Accessed 02/06/2022.

European Medicines Agency Decision P/0060/2021. European Medicines Agency [online]. Accessed 07/09/2022.

Joint Formulary Committee. Remdesivir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/09/2022.

Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment. U.S. FDA. https://www.fda.gov. Accessed 07/07/2020.

Should Remdesivir be used for COVID-19?. Ministry of Health - Singapore. https://www.moh.gov.sg. Accessed 29/07/2020.

Summary on Compassionate Use - Remdesivir Gilead. European Medicines Agency [online]. Accessed 07/07/2020.

Veklury 100 mg Concentrate for Solution for Infusion (Gilead Sciences Ireland UC). European Medicines Agency [online]. Accessed 07/07/2020.

Veklury 100 mg Concentrate for Solution for Infusion (Gilead Sciences Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/09/2022.

Veklury 100 mg Powder for Concentrate for Solution for Infusion (Gilead Sciences Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2022.

Veklury for Injection, for Intravenous Use and Veklury Injection, for Intravenous Use (Gilead Sciences, Inc.). U.S. FDA. https://www.fda.gov. Accessed 02/06/2022.

Veklury Injection and Veklury Injection, Powder, Lyophilized, for Solution (Gilead Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/09/2022.

Veklury Lyophilized Powder for Injection (Gilead Sciences Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/09/2022.

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