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Other strengths and forms by Renata PLC
Indications & Uses
Remdesivir is authorized for emergency use in treating suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease means a patient has an oxygen saturation (Sp02) below 94% on room air, or needs supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Remdesivir is only authorized for hospitalized adult and pediatric patients for whom an intravenous medicine is clinically appropriate.
Pharmacology
Remdesivir is an adenosine nucleotide prodrug. It moves into cells, where it is metabolized to its active form, a nucleoside triphosphate metabolite called Remdesivir Triphosphate. This conversion has been shown in multiple cell types.
Remdesivir Triphosphate acts as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate. Both try to get incorporated into the new RNA chains being built by the SARS-CoV-2 RNA-dependent RNA polymerase. When Remdesivir Triphosphate is taken in, the chain stops growing later than it otherwise would (delayed chain termination), and this happens during replication of the viral RNA.
Remdesivir Triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase, and it has a low potential for mitochondrial toxicity.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage general information
Before giving Remdesivir, check kidney function. Adults and children older than 28 days need an eGFR. Full-term neonates (≥7 days to ≤28 days old) need serum creatinine. Hepatic laboratory testing should be done in all patients before starting Remdesivir, and then daily while they are receiving it. Remdesivir should be given by intravenous infusion only. Do not give it as an intramuscular injection.
Adult Patients
For adults who need invasive mechanical ventilation and/or ECMO, the recommended dosage is a single loading dose of Remdesivir 200 mg on day 1, followed by a once daily maintenance dose of Remdesivir mg for 9 days. For adults who don't need invasive mechanical ventilation and/or ECMO, the recommended dose is a single dose of Remdesivir 200 mg on day 1, followed by a once daily maintenance dose of Remdesivir mg for 4 days. If the 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 given by intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.
Pediatric Patients
For pediatric patients weighing between 3.5 kg <40 kg, the dose should be calculated using the mg/kg dose according to the patient's weight. In this weight group, use Remdesivir for injection 100 mg lyophilized powder only. The body weight-based regimen is 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 the 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 regimen is used. That is one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1, followed by Remdesivir mg IV (infused over 30 to 120 minutes) once daily for 9 days.
For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult regimen is again used. That is one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1, followed by Remdesivir mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5). If the 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).
Side Effects
In clinical trials of Remdesivir in healthy adults, the adverse reaction reported was a rise in liver transaminases.
Cautions & Contraindications
Warnings & Precautions
Not much clinical data is available on Remdesivir so far. Because of this, serious and unexpected adverse events can occur that nobody has reported before with Remdesivir use.
Contraindications
Remdesivir must not be given to anyone who is already known to be hypersensitive to Remdesivir.
Pregnancy & Breastfeeding
No adequate and well controlled studies of Remdesivir have been done in pregnant women. So it should be used in pregnancy only if the possible benefit to the mother justifies the possible risk to the fetus.
There is no information on whether Remdesivir passes into human milk, what effect it has on breastfed infants, or whether it changes milk production. When a breastfeeding mother needs Remdesivir, the doctor should weigh several things together: the development and health benefits of breastfeeding, the mother's clinical need for the medicine, and the chance of side effects in the breastfed child, either from Remdesivir or from the mother's own condition. There is also the risk that a SARS-CoV-2 negative infant could catch the virus, and the risk of adverse reactions to the drug in the infant.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Don't reuse or save any unused Remdesivir lyophilized powder, injection solution or diluted solution for infusion. Remdesivir contains no preservatives.
Lyophilized powder: Store Remdesivir for injection, 100 mg, vials at a temperature not exceeding 30°C, in a dry place, until you need them. Protect the vials from light and moisture. Do not use them after the expiry date.
After reconstitution: The vials can be kept for up to 4 hours at room temperature (20°C-25°C) before administration, or for 24 hours in a refrigerator (2°C-8°C). Dilute within the same day as administration.
Diluted solution for infusion: Store the diluted Remdesivir solution for infusion for up to 4 hours at room temperature (20°C-25°C), or for 24 hours in a refrigerator (2°C-8°C).
Common questions about Renavir 100 mg
What is Renavir 100 mg Injection?
Renavir 100 mg Injection is a medicine that contains Remdesivir. It is made by Renata PLC. It belongs to the Anti-viral drugs group of medicines.
What is Renavir used for?
Remdesivir is authorized for emergency use in treating suspected or laboratory confirmed Corona Virus Disease 2019 (COVID-19). Severe disease means a patient has an oxygen saturation (Sp02) below 94% on room air, or needs supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
What are the side effects of Renavir?
In clinical trials of Remdesivir in healthy adults, the adverse reaction reported was a rise in liver transaminases.
Can I take Renavir during pregnancy or while breastfeeding?
No adequate and well controlled studies of Remdesivir have been done in pregnant women. So it should be used in pregnancy only if the possible benefit to the mother justifies the possible risk to the fetus. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Renavir?
Don't reuse or save any unused Remdesivir lyophilized powder, injection solution or diluted solution for infusion. Remdesivir contains no preservatives.
Do I need a prescription for Renavir?
Renavir is a prescription (Rx) medicine. Take it as your doctor advises.