Table 1.
Summary of the prescribing information of nirmatrelvir plus ritonavir (Paxlovid™) for the treatment of COVID-19 in the USA [7] and the EU [6]
| What is the authorized indication for nirmatrelvir plus ritonavir? | |
| USA | Treatment of mild-to-moderate COVID-19 in adults and paediatric pts (aged ≥ 12 years weighing ≥ 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death (EUA) |
| EU | Treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19 |
| What is the recommended dosage of nirmatrelvir plus ritonavir? | |
| Nirmatrelvir 300 mg (two 150 mg tablets) with ritonavir 100 mg (one 100 mg tablet) all taken together orally twice daily for 5 days | |
| How should nirmatrelvir plus ritonavir be administered? | |
| Take with or without food; swallow tablets whole (do not chew, break or crush) | |
| Initiate treatment as soon as possible after COVID-19 diagnosis and within 5 days of symptom onset | |
| Complete full 5-day treatment course even if pt requires hospitalization due to severe or critical COVID-19 after starting treatment | |
| What are the contraindications to the use of nirmatrelvir plus ritonavir? | |
| Pts with a history of clinically significant hypersensitivity reactions to nirmatrelvir, ritonavir, or any other components of the product | |
| Pts receiving drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions | |
| Pts receiving drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virological response and possible resistance | |
| How should nirmatrelvir plus ritonavir be used in special populations? | |
| Kidney impairment | Mild: no dosage adjustment required |
| Moderate (eGFR ≥ 30 to < 60 mL/min): reduce dosage of nirmatrelvir to 150 mg twice daily | |
| Severe (eGFR < 30 mL/min): not recommended for use | |
| Hepatic impairment | Mild or moderate (Child-Pugh Class A or B): no dosage adjustment required |
| Severe (Child-Pugh Class C): not recommended for use | |
| Pts receiving other products containing ritonavir or cobicistat | No dosage adjustment required |
| What other special warnings/precautions pertain to the use of nirmatrelvir plus ritonavir? | |
| Hepatotoxicity | May cause hepatic transaminase elevations, clinical hepatitis and jaundice; exercise caution in pts with pre-existing liver disease, liver enzyme abnormalities or hepatitis |
| HIV-1 resistance | May increase risk of HIV-1 developing resistance to HIV protease inhibitors in pts with uncontrolled or undiagnosed HIV-1 infection |
| Allergic reactions/hypersensitivity | May cause hypersensitivity reactions; discontinue immediately if signs/symptoms of clinically significant hypersensitivity or anaphylaxis occur and initiate appropriate medications and/or supportive care (USA) |
Unless otherwise stated, information applies to both the USA and the EU. Consult local prescribing information for further details
COVID-19 coronavirus disease 2019; eGFR estimated glomerular filtration rate, EUA Emergency Use Authorization, pt(s) patient(s), SARS-CoV-2 severe acute respiratory syndrome coronavirus 2