VEKLURY

What it is

VEKLURY is remdesivir, supplied as a powder for injection. Each vial contains 100 mg of remdesivir, which after reconstitution contains 5 mg/mL of remdesivir solution. VEKLURY is a sterile, preservative-free, white to off-white to yellow lyophilised powder that is to be reconstituted with 19 mL of Sterile Water for Injection and further diluted into 0.9% sodium chloride infusion bag prior to administration by intravenous infusion. This medicinal product is subject to additional monitoring in Australia, which will allow quick identification of new safety information.

Approved indications —

Adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) who have pneumonia due to SARS-CoV-2, and who require supplemental oxygen. — Adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

Dosing overview

VEKLURY is to be administered via intravenous infusion over 30 to 120 minutes.

Key safety warnings

Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration of VEKLURY. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnoea, wheezing, angioedema, rash, nausea, vomiting, diaphoresis, and shivering. Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent these signs and symptoms. VEKLURY may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and access to an emergency medical response. Transaminase elevations have been observed in healthy volunteers who received VEKLURY and have also been reported in patients with COVID-19 who received VEKLURY. Hepatic laboratory testing should be performed in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate. VEKLURY should be considered for discontinuation if ALT levels increase to greater than 10 times the upper limit of normal, and should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation. Patients should have estimated glomerular filtration rate (eGFR) determined prior to starting VEKLURY and while receiving VEKLURY as clinically appropriate. Patients with severe renal impairment and end-stage renal disease should be closely monitored for adverse events during treatment with remdesivir due to significantly higher exposure of the metabolite GS-441524. The excipient sulfobutyl betadex sodium is renally cleared and accumulates in patients with decreased renal function, which may potentially adversely affect renal function.

Contraindications

VEKLURY is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients.

PBS listing

No Pharmaceutical Benefits Scheme listing information is available in the provided documents.

Regulatory history

VEKLURY (remdesivir 100 mg powder for injection) was first listed on the ARTG on 10 July 2020. The TGA provisionally approved VEKLURY on 5 May 2022 for the treatment of COVID-19 in paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen, and in adults and paediatric patients (weighing at least 40 kg) at high risk of progressing to severe COVID-19. This decision was based on limited data, with more comprehensive evidence required for submission.