Remdigen IV Infusion

Remdesivir is a preparation of Remdesivir. It is an 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 act as an analogue 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 polymerase with low potential for mitochondrial toxicity.

General Information-

• 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.

Adult Patients-

• 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.

Pediatric Patients-

• 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 prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg

Infusion bag 250 ml:

• Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
• Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
• Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min

Infusion bag 100 ml:

• Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
• Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
• Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min

Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.

An adverse reaction associated with Remdigen in clinical trials in healthy adult subjects was increased liver transaminases.

No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.

There are limited clinical data available for Remdigen. Serious and unexpected adverse events may occur that have not been previously reported with Remdigen use.

Anti-viral drugs

Reconstitution instructions:

• Aseptically reconstitute Remdigen lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
• Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
• Immediately shake the vial for 30 seconds.
• Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
• If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
• Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
• Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.

Please do not reuse or save unused Remdigen Lyophilized powder, injection solution or diluted solution for infusion for further use. Remdigen contains no preservatives.

Lyophilized Powder: Please store Remdigen for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.

After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.

Diluted Solution for Infusion: Please store diluted Remdigen solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).