Dosing
PAXLOVID dosing and administration
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PAXLOVID tablets
Standard dose pack
- The standard dose of PAXLOVID is 300 mg nirmatrelvir with 100 mg ritonavir taken together orally twice daily for 5 days
- Each dose consists of two 150 mg nirmatrelvir tablets and one 100 mg ritonavir tablet
Patients should complete the entire course of treatment as prescribed, with twice daily dosing
Reduced dose
- The reduced dose of PAXLOVID is 150 mg nirmatrelvir and 100 mg ritonavir taken together orally twice daily for 5 days
- The reduced dose is for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min)
- Each dose consists of one 150 mg nirmatrelvir tablet and one 100 mg ritonavir tablet
Patients should complete the entire course of treatment as prescribed, with twice daily dosing
PAXLOVID is not recommended for use in patients with severe renal impairment (eGFR <30 mL/min) or patients with end-stage renal disease (eGFR <15 mL/min) receiving dialysis until more data are available. The appropriate dosage for patients with severe renal impairment has not been determined.
Hepatic Impairment
No dosage adjustment is needed in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of nirmatrelvir or ritonavir in participants with severe (Child-Pugh Class C) hepatic impairment; therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment.
Important administration information
- Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir may result in plasma levels of nirmatrelvir that are insufficient to achieve the desired therapeutic effect
- Prescriptions should specify the numeric dose of each active ingredient in PAXLOVID. Healthcare providers should counsel patients about reduced dosing instructions
- The 5-day treatment course of PAXLOVID should be initiated as soon as possible after a COVID-19 diagnosis and within 5 days of symptom onset
- Alert the patient of the importance of completing the full 5-day treatment course and of continuing isolation in accordance with public health recommendations to maximize viral clearance and minimize transmission of SARS-CoV-2
- If the patient misses a dose of PAXLOVID 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
Dose adjustments
- No dosage adjustment is recommended in patients with mild renal impairment (eGFR ≥60 to <90 mL/min)
- No dosage adjustment is required when coadministered with other products for HIV containing ritonavir or cobicistat
- Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated
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Drug Interactions
View boxed warning, contraindicated drugs, and other potentially significant drug interactions.
Efficacy
See the efficacy data from the phase 2/3 EPIC-HR trial of adult participants with a laboratory-confirmed diagnosis of SARS-CoV-2 infection at high risk for progression to severe disease.
Safety
Find out about the safety data from clinical studies and post-authorization experience and how to report an adverse event.
COVID-19=coronavirus disease 2019; eGFR=estimated glomerular filtration rate; HCV=hepatitis C virus; HIV=human immunodeficiency virus; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
Reference:
- Fact Sheet for Healthcare Providers: Emergency Use Authorization for PAXLOVID™. Pfizer Inc.; 2024.