Dilavir IV Infusion

Introduction

Dilavir IV Infusion 5 mg/ml is a broad-spectrum antiviral medicine developed and approved for the treatment of severe coronavirus disease 2019 (COVID-19). It was initially developed for the treatment of the hepatitis virus.

Uses

Dilavir IV Infusion 5 mg/ml is used to treat severe coronavirus disease 2019 (COVID-19) in adult and pediatric patients who have been hospitalized and have evidence of moderate to severe disease. It is also being evaluated for potential use in the treatment of other viruses.

Mechanism of Action

Dilavir IV Infusion 5 mg/ml works by blocking the virus’s ability to replicate. It does this by inhibiting a viral enzyme known as RNA-dependent-RNA polymerase, which is responsible for producing new virus particles from viral genetic material. This stops the virus from spreading and reproducing, limiting its growth in the body.

How Long Does it Take to Work?

The effects of remdesivir can vary significantly depending on the patient and their particular infection. Generally, it is expected to take anywhere from a few days to two weeks for the drug to take effect and begin to reduce symptoms.

Absorption

Dilavir IV Infusion 5 mg/ml is rapidly and widely distributed throughout the body after being orally administered. It is extensively absorbed via the intestine and has a bioavailability of around 64%.

Route of Elimination

Dilavir IV Infusion 5 mg/ml is primarily eliminated through the kidneys, with around 95% of the drug being eliminated within three days.

Dosage

• Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
• Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
• Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.

• The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
• The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
• Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.

• The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
• For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
• For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
• For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).

The recommended daily dose of remdesivir is 200mg administered intravenously over one hour, followed by 100mg administered every 24hours for five days. In adults and pediatric patients, this dose should be administered as an intravenous infusion over one hour.

Administration

Dilavir IV Infusion 5 mg/ml is administered intravenously via a drip. It is important to ensure that the infusion is at a slow and steady rate, with no interruption of the infusion.

Side Effects

The most common side effects of remdesivir include nausea, vomiting, headache, weakness, dizziness, diarrhea, difficulty sleeping, and abdominal pain. Other more serious side effects can occur, although these are much rarer.

Toxicity

Dilavir IV Infusion 5 mg/ml is generally well-tolerated and has a low risk of toxicity. However, seizure has been reported in rare cases where the drug was overdosed or used in patients with reduced renal or hepatic function.

Precautions

Dilavir IV Infusion 5 mg/ml should be used with caution in patients with impaired liver or kidney function, as well as in pregnant or lactating women. It should also be used with caution in patients with preexisting cardiovascular conditions or who are taking any other medications that may interact with remdesivir.

Interactions

Dilavir IV Infusion 5 mg/ml may interact with other medications, including antibiotics, anticonvulsants, immunosuppressants, and antiretroviral drugs. It is important to tell your doctor about all other medications you are taking before starting treatment with remdesivir.

Disease Interaction

Dilavir IV Infusion 5 mg/ml should not be used in patients with severe hepatic impairment or in patients with HIV infection. Its efficacy in the treatment of other diseases is not yet known.

Drug Interaction

Dilavir IV Infusion 5 mg/ml may interact with various other medications, including antibiotics, anticonvulsants, immunosuppressants, and antiretroviral drugs. Before starting treatment with remdesivir, it is important to tell your doctor about all other medications you are taking.

Food Interactions

It is not known if food or other substances will affect the absorption of remdesivir. Therefore, it is recommended that you take remdesivir on an empty stomach.

Pregnancy Use

Dilavir IV Infusion 5 mg/ml should be used with caution in pregnant females as the safety and effectiveness of the drug have not been established in this population.

Lactation Use

Dilavir IV Infusion 5 mg/ml should be used with caution in nursing mothers as the safety and effectiveness of the drug have not been established in this population.

Acute Overdose

Dilavir IV Infusion 5 mg/ml should not be used in larger doses than recommended, as this may lead to an acute overdose. Symptoms of an overdose can include seizures, confusion, disorientation, agitation, tremors, and coma. If you suspect an overdose, seek medical help immediately.

Contraindication

Dilavir IV Infusion 5 mg/ml should not be used in patients with moderate to severe hepatic impairment or in patients with HIV infection.

Use Direction

Dilavir IV Infusion 5 mg/ml should be administered intravenously over one hour, followed by a second dose one hour later and a third dose twenty-four hours later. Patients should be monitored for at least sixty minutes after the administration of each dose.

Storage Condition

Dilavir IV Infusion 5 mg/ml should be stored at room temperature, between 20 and 25oC. It should not be frozen or refrigerated.

Volume of Distribution

The volume of distribution of remdesivir is approximately 18 L.

Half Life

The half-life of remdesivir is approximately 4.8 hours.

Clearance

The clearance of remdesivir is approximately 5.4 L/hr.

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