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. Initiate therapy as soon as possible after diagnosis of symptomatic COVID-19. 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 therapy as soon as possible after diagnosis of COVID-19 and within 7 days of symptoms onset. 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 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:
- The safety and efficacy of remdesivir for the treatment of COVID-19 is being evaluated continuously, clinical data are available from several initial trials in the US and other countries.
- Remdesivir may be available for use in some countries under provisional approval. Please refer to local regulatory agencies for relevant information and latest comprehensive clinical evidence.
- Remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care and has access to an emergency medical response.
- Remdesivir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended.
For healthcare professionals:
- Please refer to local regulatory agencies for latest prescribing guidelines and other relevant information on the use of remdesivir for COVID-19.
- No specific drug-drug interaction data are available. Minimise any unnecessary co-medication whenever possible given the lack of information about interaction risk.
Tác dụng không mong muốn
Significant: Increased transaminase levels, hepatitis; infusion-related and anaphylactic reactions, including angioedema, diaphoresis, dyspnoea, bradycardia or tachycardia, hypotension or hypertension, nausea, rash, fever, shivering, vomiting, hypoxia, wheezing; prolonged prothrombin time/INR. 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: Mechanism of Action: 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
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).
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
Anon. Remdesivir. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/03/2023.Anon. Remdesivir. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2023.Buckingham R (ed). Remdesivir. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2023.Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children. U.S. FDA. https://www.fda.gov. Accessed 02/06/2022.Joint Formulary Committee. Remdesivir. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2023.Veklury 100 mg Concentrate for Solution for Infusion (Gilead Sciences Ireland UC). European Medicines Agency [online]. Accessed 07/09/2022.Veklury 100 mg Concentrate for Solution for Infusion (Gilead Sciences Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/03/2023.Veklury 100 mg Powder for Concentrate for Solution for Infusion (Gilead Sciences Ltd). MHRA. https://products.mhra.gov.uk. Accessed 07/03/2023.Veklury for Injection, for Intravenous Use and Veklury Injection, for Intravenous Use (Gilead Sciences, Inc.). U.S. FDA. https://www.fda.gov. Accessed 22/03/2023.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 07/03/2023.Veklury Lyophilized Powder for Injection (Gilead Sciences Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/03/2023.
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