Clinical Pharmacology Details


Remdesivir


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Indications & Dose:

Treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged twelve years and older with body weight at least 40


kilograms (88 lb)) with pneumonia requiring supplemental oxygen and requiring hospitalization. injection, lyophilized powder for reconstitution


100mg/vial injection, concentrated solution 100mg/20mL (5mg/mL)


Coronavirus Disease 2019 (COVID-19)


Indicated for adults and pediatric patients aged =12 years who weigh =40 kg for treatment of COVID-19 requiring hospitalization\Day 1 loading


dose: 200 mg IV infused over 30-120 min, THEN Day 2 and thereafter: 100 mg IV qDay


Treatment duration


Not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; if clinical improvement not


demonstrated, treatment may be extended up to 10 days total Requires invasive mechanical ventilation and/or ECMO: 10 days


 

Contraindications:

Side Effects:

The most common adverse effects in studies of remdesivir for COVID-19 include respiratory failure and organ impairment, including low albumin,


low potassium, low count of red blood cells, low count of platelets that help with clotting, and yellow discoloration of the skin. Other reported side


effects include gastrointestinal distress, elevated transaminase levels in the blood (liver enzymes), and infusion site reactions.\Other possible side


effects of remdesivir include: Infusion-related reactions. Infusion-related reactions have been seen during a remdesivir infusion or around the


time remdesivir was given.  Signs and symptoms of infusion-related reactions may include: low blood pressure, nausea, vomiting, sweating, and


shivering.  Increases in levels of liver enzymes, seen in abnormal liver blood tests.[  Increases in levels of liver enzymes have been seen in


people who have received remdesivir, which may be a sign of inflammation or damage to cells in the liver. 


 


 

Cautions:

Precautions:

Interaction:

Warnings:

Adverse Effects:

Lactations:

Renal impairment


Pharmacokinetics have not been evaluated in patients with renal impairment eGFR =30 mL/min: No dose adjustment eGFR<30 mL/min: Not


recommended; sulfobutylether-beta-cyclodextrin sodium salt (SBECD) excipient in the concentrated solution is renally cleared and accumulates in


patients with decreased renal function


Hepatic impairment


Not evaluated; unknown if dosage adjustment required Dosing Considerations


 

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: