Eskayef Pharmaceuticals Ltd.
Dosage & Administration
Nirmatrelvir must be co-administered with Ritonavir. Initiate this treatment as soon as possible after diagnosis of COVID-19 and within 3-5 days of symptom onset. Administer orally with or without food.
Dosage: 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg Ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days.
Missed Dose: If the patient misses a dose of this within 8 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 8 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
- History of clinically significant hypersensitivity reactions to the active ingredients (Nirmatrelvir or Ritonavir) or any other components.
- Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.
- Co-administration with potent CYP3A inducers where significantly reduced Nirmatrelvir or Ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.
Pregnancy & Lactation
Precautions & Warnings
The concomitant use of this tablet and certain other drugs may result in potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions.
Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving Ritonavir.
HIV-1 Drug Resistance: This tablet use may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
Use in Special Populations
Pediatric Use: This tablet is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of this tablet have not been established in pediatric patients.
Geriatric Use: Clinical studies of this tablet include subjects 65 years of age and older and their data contributes to the overall assessment of safety and efficacy.
Renal Impairment: No dosage adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment (eGFR >30 to <60 mL/min), reduce the dose of This tablet to 150 mg Nirmatrelvir and 100 mg Ritonavir twice daily for 5 days. This tablet is not recommended in patients with severe renal impairment (eGFR <30 mL/min).
Hepatic Impairment: No dosage adjustment of this tablet is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. This tablet is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).