(nirmatrelvir tablets; ritonavir tablets)
2 DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Information
PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. There are three different dose packs available:
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- PAXLOVID (nirmatrelvir; ritonavir) co-packaged for oral use 300 mg;100 mg [see Dosage and Administration (2.2)].
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- PAXLOVID (nirmatrelvir; ritonavir) co-packaged for oral use 150 mg;100 mg for patients with moderate renal impairment [see Dosage and Administration (2.3)].
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- PAXLOVID (nirmatrelvir; ritonavir) co-packaged for oral use 300 mg;100 mg (Day 1) and 150 mg;100 mg (Days 2-5) for patients with severe renal impairment [see Dosage and Administration (2.3)].
Nirmatrelvir must be co-administered with ritonavir. Failure to correctly co-administer 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 within PAXLOVID [see Dosage and Administration (2.2, 2.3)]. Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2.
The 5-day treatment course of PAXLOVID should be initiated as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset even if baseline COVID-19 symptoms are mild. Should a patient require hospitalization due to severe or critical COVID-19 after starting treatment with PAXLOVID, the patient should complete the full 5-day treatment course per the healthcare provider's discretion.
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.
PAXLOVID (both nirmatrelvir and ritonavir tablets) can be taken with or without food [see Clinical Pharmacology (12.3)]. The tablets should be swallowed whole and not chewed, broken, or crushed.
2.2 Recommended Dosage
The recommended dosage for PAXLOVID is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all 3 tablets taken together orally twice daily in the morning and at bedtime for 5 days.
2.3 Dosage in Patients with Renal Impairment
Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions [see Patient Counseling Information (17)].
No dosage adjustment is recommended in patients with mild renal impairment [estimated glomerular filtration rate (eGFR) ≥60 to <90 mL/min].
In patients with moderate renal impairment (eGFR ≥30 to <60 mL/min) or with severe renal impairment (eGFR <30 mL/min) including those requiring hemodialysis, the dosage of PAXLOVID should be reduced as shown in Table 1. PAXLOVID should be administered at approximately the same time each day for 5 days. On days patients with severe renal impairment undergo hemodialysis, the PAXLOVID dose should be administered after hemodialysis [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and How Supplied/Storage and Handling (16)].
Table 1: Recommended Dose and Regimen for Patients with Renal Impairment
| Abbreviation: eGFR=estimated glomerular filtration rate. | ||
Renal Function | Days of Treatment | Dose and Dose Frequency* |
Moderate renal impairment (eGFR ≥30 to <60 mL/min) | Days 1-5 | 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) twice daily |
Severe renal impairment (eGFR <30 mL/min) including those requiring hemodialysis† | Day 1 | 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) once |
Days 2-5 | 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) once daily | |
2.4 Use in Patients with 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 subjects with severe (Child-Pugh Class C) hepatic impairment; therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].
MEDICATION GUIDE
PATIENT INFORMATION | ||||||
What is the most important information I should know about PAXLOVID? PAXLOVID can interact with other medicines causing severe or life-threatening side effects or death. It is important to know the medicines that should not be taken with PAXLOVID. Do not take PAXLOVID if:
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These are not the only medicines that may cause serious or life-threatening side effects if taken with PAXLOVID. PAXLOVID may increase or decrease the levels of multiple other medicines. It is very important to tell your healthcare provider about all of the medicines you are taking because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with PAXLOVID. Your healthcare provider may also tell you about specific symptoms to watch out for that may indicate that you need to stop or decrease the dose of some of your other medicines.
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What is PAXLOVID? PAXLOVID is not approved for use as pre-exposure or post-exposure treatment for prevention of COVID-19. | ||||||
Before taking PAXLOVID, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Tell your healthcare provider if you are taking combined birth control (hormonal contraceptive). PAXLOVID may affect how your hormonal contraceptives work. Females who are able to become pregnant should use another effective alternative form of contraception or an additional barrier method of contraception during treatment with PAXLOVID. Talk to your healthcare provider if you have any questions about contraceptive methods that might be right for you. | ||||||
How should I take PAXLOVID?
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If you are prescribed PAXLOVID 300 mg; 100 mg Dose Pack | ||||||
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How to take PAXLOVID 300 mg; 100 mg Dose Pack | ||||||
 | Morning Dose: | |||||
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 | Bedtime Dose: | |||||
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If you are prescribed PAXLOVID 150 mg; 100 mg Dose Pack | ||||||
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How to take PAXLOVID 150 mg; 100 mg Dose Pack | ||||||
 | Morning Dose: | |||||
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 | Bedtime Dose: | |||||
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If you are prescribed PAXLOVID 300 mg; 100 mg (Day 1) and 150 mg; 100 mg (Days 2-5) | ||||||
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How to take PAXLOVID 300 mg; 100 mg (Day 1) and 150 mg; 100 mg (Days 2-5) | ||||||
 | Day 1 (First Day): Take the 2 pink nirmatrelvir tablets and | |||||
 | Days 2-5: Take the 1 pink nirmatrelvir tablet and 1 white ritonavir tablet together | |||||
Talk to your healthcare provider if you do not feel better or if you feel worse after 5 days. | ||||||
What are the possible side effects of PAXLOVID? PAXLOVID may cause serious side effects, including:
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The most common side effects of PAXLOVID include: altered sense of taste (such as metallic, bitter taste) and diarrhea. Other possible side effects include:
These are not all of the possible side effects of PAXLOVID. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||||||
How should I store PAXLOVID?
Keep PAXLOVID and all medicines out of the reach of children. | ||||||
General information about the safe and effective use of PAXLOVID. | ||||||
What are the ingredients in PAXLOVID? | ||||||
 LAB-1524-5.0 | ||||||
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2026
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