Jupitavir (Nirmatrelvir 150 mg & Ritonavir 100 mg )

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Jupitavir(Nirmatrelvir 150 mg & Ritonavir 100 mg )

Therapeutic Group: SARS-CoV-2 main protease (Mpro: also referred to as 3CLpro or nsp5 protease) inhibitor, and Ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor.

Presentation

Nirmatrelvir tablet: Each film-coated Nirmatrelvir tablet contains Nirmatrelvir INN 150 mg.

Ritonavir tablet: Each film-coated Ritonavir tablet contains Ritonavir USP 100 mg

Description

Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 40 kg) with positive results of SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including

hospitalization or death.

Indications

Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 40 kg) with positive results of SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Dosage & Administration

JupitavirTM consists of 2 medicines: Nirmatrelvir and Ritonavir. Nirmatrelvir must be co-administered with
Ritonavir.
1. Initiate JupitavirTM treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
2. Administer orally with or without food.
3. 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg Ritonavir (one 100 mg tablet), all three tablets taken together twice daily for 5 days.
4. Dose reduction for moderate renal impairment (eGFR ≥30 to <60 mL/min): 150 mg Nirmatrelvir tablet and 100 mg Ritonavir tablet, both tablets taken together twice daily for 5 days.
5. JupitavirTM is not recommended in patients with severe renal impairment (eGFR <30 mL/min).
6. JupitavirTM is not recommended in patients with severe hepatic impairment.

Side Effects

Adverse events were dysgeusia, diarrhea, hypertension, and myalgia

Precautions

N/A

Use in Pregnancy & Lactation

There are no available human data on the use of Nirmatrelvir during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal of fetal outcomes. Published observational studies on Ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with Ritonavir are insufficient to identify a drug-associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.

Drug Interaction

Co-administration of JupitavirTM can alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of JupitavirTM. Consider the potential for drug interactions prior to and during JupitavirTM therapy and review concomitant medications during JupitavirTM therapy.
There are no available data on the presence of Nirmatrelvir in human or animal milk, the effects on the breastfed inhant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered Nirmatrelvir. there is no information on the effects of Ritonavir on the breastfed infant or the effects of the drug on milk production.

Storage

Do not store above 30 ⁰C. Keep away from light and out of the reach of the children

Commercial Pack

Do not store above 30 ⁰C. Keep away from light and out of the reach of the children

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