Veklury (remdesivir)

Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Hypersensitivity Including Infusion-related and Anaphylactic Reactions

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, dyspnea, wheezing, angioedema, rash, nausea, 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. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of Veklury. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of Veklury and initiate appropriate treatment. The use of Veklury is contraindicated in patients with known hypersensitivity to Veklury or any components of the product.

Increased Risk of Transaminase Elevations

Transaminase elevations have been observed in healthy volunteers who received 200 mg of Veklury followed by 100 mg doses for up to 10 days; the transaminase elevations were mild (Grade 1) to moderate (Grade 2) in severity and resolved upon discontinuation of Veklury. Transaminase elevations have also been reported in patients with COVID-19 who received Veklury. Because transaminase elevations have been reported as a clinical feature of COVID-19, and the incidence was similar in patients receiving placebo versus Veklury in clinical trials of Veklury, discerning the contribution of Veklury to transaminase elevations in patients with COVID-19 can be challenging.

Perform hepatic laboratory testing in all patients before starting Veklury and while receiving Veklury as clinically appropriate

The following adverse reactions have been identified during use of Veklury under Emergency Use Authorization:

• General disorders and administration site conditions: Administration site extravasation
• Skin and subcutaneous tissue disorders: Rash
• Immune system disorders:
  • Anaphylaxis,
  • angioedema,
  • infusion-related reactions,
  • hypersensitivity
• Investigations: Transaminase elevations.

Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older and Weighing at Least 40 kg

The recommended dosage for adults and pediatric patients 12 years of age and older and weighing at least 40 kg is a single loading dose of Veklury 200 mg on Day 1 via intravenous infusion followed by once-daily maintenance doses of Veklury 100 mg from Day 2 via intravenous infusion.

The recommended treatment duration for patients not requiring invasive mechanical ventilation

and/or extracorporeal membrane oxygenation (ECMO) 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.

• The recommended total treatment duration for patients requiring invasive mechanical ventilation and/or ECMO is 10 days.
• Veklury must be diluted prior to intravenous infusion.

Due to antagonism observed in cell culture, concomitant use of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended.

Drug-drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Remdesivir and its metabolites are in vitro substrates and/or inhibitors of certain drug metabolizing enzymes and transporters. The clinical relevance of these in vitro assessments has not been established.

Available data from published case reports and compassionate use of remdesivir in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In nonclinical reproductive toxicity studies, remdesivir demonstrated no adverse effect on embryo-fetal development when administered to pregnant animals.

Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality.

There are no available data on the presence of remdesivir in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies, remdesivir and metabolites have been detected in the nursing pups of mothers given remdesivir, likely due to the presence of remdesivir in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veklury and any potential adverse effects on the breastfed child from Veklury or from the underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.