WHAT DO YOU KNOW ABOUT REMDESIVIR?THE DRUG ALLEGED TO TREAT CORONAVIRUS.

remdesivir tablet

Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. As of  2020, remdesivir is under investigation as a specific treatment for COVID-19 and has been authorized by the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) for emergency treatment for those hospitalized with severe disease. It may have an effect on the time it takes to recover from the disease. It is given by injection into a vein.

SECTIONS

Dosing & Uses

ADULT PEDIATRIC

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

100mg/vial

injection, solution

100mg/20mL (5mg/mL)

Coronavirus Disease 2019 (COVID-19) (Investigational)

May 1, 2020: The FDA has granted an emergency use authorization (EUA) for remdesivir to treat hospitalized adults and children with suspected or laboratory-confirmed SARS CoV-2 infection and severe COVID-19 disease

EUA facilitates broader use of remdesivir, enabling access at additional hospitals across the country

Severe COVID-19 disease is defined as patients with oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO)

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Optimal treatment duration is unknown for coronavirus patients; for this EUA, dosing is as follows:

Dosage (weight 40 kg or more)

Requires mechanical ventilation and/or ECMO

Day 1 loading dose: 200 mg IV infused over 30-120 min, then

Days 2-10 maintenance dose: 100 mg IV QID

Does not require mechanical ventilation and/or ECMO

Day 1 loading dose: 200 mg IV infused over 30-120 min, then

Days 2-5 maintenance dose: 100 mg IV QID

If clinical improvement not demonstrated, treatment may be extended for up to 5 additional days (ie, up to 10 days total)

Dosage Modifications

Renal impairment

Pharmacokinetics have not been evaluated in patients with renal impairment

Use in patients with renal impairment are based on potential risk and potential benefit considerations

eGFR ≥30 mL/min: No dose adjustment

eGFR <30 mL/min: Not recommended unless the potential benefit outweighs the potential risk

Hepatic impairment

Not evaluated; unknown if dosage adjustment required

Use only if the potential benefit outweighs the risk

Mechanism of action.

Adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite

Metabolism of remdesivir to remdesivir triphosphate has been demonstrated in multiple cell types

Remdesivir triphosphate acts as an analog of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA

Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerases with low potential for mitochondrial toxicity

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

• 100mg/vial

injection, solution

• 100mg/20mL (5mg/mL

Resistance.

Mutations in the mouse hepatitis virus RNA replicase that cause partial resistance to remdesivir were identified in 2018. These mutations make the viruses less effective in nature, and the researchers believe they will likely not persist where the drug is not being used.

Has remdesivir been used in other cases?

Remdesivir was shown in 2019 to have possible promise for treating feline infectious peritonitis caused by a coronavirus. It has not been evaluated or approved by the Food and Drug Administration (FDA) for the treatment of feline coronavirus or feline infectious peritonitis but has been available since 2019 through websites and social media as an unregulated black market substance as confirmed by the UC Davis School of Veterinary Medicine .

Side effects.

In the Ebola trial, researchers noted side effects of remdesivir (RDV) that included:

Increased liver enzyme levels that may indicate possible liver damage

Researchers documented similar increases in liver enzymes in three U.S. COVID-19 patients

Typical antiviral drug side effects include:

.Nausea

.vomiting

Use of ramdesivir in pregnancy and breastfeeding.

Tell your doctor if you are pregnant or plan to become pregnant; it is unknown if remdesivir (RDV) will affect a fetus or impact in pregnancy. In rats and monkeys, RDV affected kidney development in fetuses.

It is unknown if remdesivir (RDV) passes into breast milk. Consult your doctor before breastfeeding.