Paxlovid Dosage/Direction for Use

Paxlovid is nirmatrelvir tablets co-packaged with ritonavir tablets.
Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister Nirmatrelvir with ritonavir will result in plasma concentrations of nirmatrelvir that will be insufficient to achieve the desired therapeutic effect.
Posology: The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally twice daily for 5 days. Paxlovid should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 5 days of onset of symptoms.
Paxlovid can be taken with or without food. The tablets should be swallowed whole and not chewed, broken or crushed.
Usage limitation: Do not take Paxlovid more than 5 consecutive days because there is no safety and efficacy study support.
Do not use Paxlovid before or after exposure for purpose of COVID-19 prevention.
Do not use Paxlovid in another indication that is not for COVID-19 treatment.
If forget to take medicine: A missed dose should be taken as soon as possible and within 8 hours of the scheduled time, and the normal dosing schedule should be resumed. If more than 8 hours has elapsed, the missed dose should not be taken and the treatment should resume according to the normal dosing schedule.
If a patient requires hospitalization due to severe or critical COVID-19 after starting treatment with Paxlovid, the patient should complete the full 5-day treatment course at the discretion of his/her healthcare provider.
Patient selection: The following medical conditions or other factors may place adult patients 18 years of age and older at high risk for progression to severe COVID-19: Older age (e.g., 60 years of age and older); Obesity or being overweight (e.g., body mass index [BMI] >25 kg/m²); Current smoker; Chronic kidney disease; Diabetes; Immunosuppressive disease or immunosuppressive treatment; Cardiovascular disease (including congenital heart disease) or hypertension; Chronic lung disease (e.g., chronic obstructive pulmonary disease, asthma [moderate to severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension); Sickle cell disease; Neurodevelopmental disorders (e.g., cerebral palsy, Down's syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies); Active cancer; Medical-related technological dependence not related to COVID-19 (e.g., tracheostomy, gastrostomy or positive pressure ventilation).
Other medical conditions or factors (e.g., race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and the approved use of Paxlovid is not limited to the medical conditions or factors listed as previously mentioned. Healthcare providers should consider the benefit-risk for an individual patient.
Special populations: Paediatric population: The safety and efficacy of Paxlovid in paediatric patients younger than 18 years of age have not yet been established.
Elderly: No dose adjustment is currently recommended for elderly patients.
Renal impairment: No dose adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment, the dose of Paxlovid should be reduced to nirmatrelvir/ritonavir 150 mg/100 mg (1 tablet of each) twice daily for 5 days. The remaining tablet of nirmatrelvir should be disposed of in accordance with local requirements (see Special precautions for disposal under Cautions for Usage).
Paxlovid is not recommended in patients with severe renal impairment (eGFR <30 ml/minute) or with renal failure as the appropriate dose has not yet been determined (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dosage adjustment of Paxlovid is needed for patients with either 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 hepatic impairment (Child-Pugh Class C), therefore, Paxlovid is contraindicated in patients with severe hepatic impairment.
Concomitant therapy with ritonavir- or cobicistat-containing regimen: No dose adjustment is needed; the dose of Paxlovid is 300 mg/100 mg twice daily for 5 days.
Patients diagnosed with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection who are receiving ritonavir- or cobicistat-containing regimen should continue their treatment as indicated.