Remdesivir

Part V

Clinical Treatment Options

Regarding Veklury/Remdesivir

Taken from an earlier excerpt

Note * October 2020 update regarding approval of COVID-19 treatment plan drug name Veklury/Remdesivir. 100mg via IV injection.

VEKLURY/ Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.

VEKLURY/ Remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

VEKLURY/Remdesivir is indicated for the treatment of adults and pediatric patients ≥12 years old and weighing ≥40 kg requiring hospitalization for COVID-19. VEKLURY/Remdesivir should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care, after confirmation of COVID-19 diagnosis. Currently available in medical facilities only.

Contraindication

* VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components, including other prescription drugs in the same classification.

Precautions and warnings for usage

* Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY.

* Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of VEKLURY. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions from occurring in real time. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment plan (see Contraindications).

* Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.

* Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of VEKLURY.

Adverse reactions

* The most common adverse reaction (≥5% all grades) was nausea.

* The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Drug interactions

* Drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Dosage and administration

* Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.

* Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.

* Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.

* Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.

Dosage and Administration Guidelines

Testing: In all patients, before initiating VEKLURY/ Remdesivir and during treatment as clinically appropriate, perform renal and hepatic laboratory testing and assess prothrombin time.

• Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of VEKLURY 200 mg on Day 1 followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 infused over 30 to 120 minutes.

• For patients not requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.

• For patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.

• Administer VEKLURY via intravenous (IV) infusion over 30 to 120 minutes.

• Renal impairment: VEKLURY is not recommended in patients with eGFR less than 30 mL/min.

Dose preparation and administration: Refer to the full prescribing information for further details for both formulations.

Dosage Forms and Strengths

• For injection: 100 mg of remdesivir as a lyophilized powder, in a single-dose vial.

• Injection: 100 mg/20 mL (5 mg/mL) remdesivir, in a single-dose vial

As per recommended by the manufacturers guidelines