Posology Adults The recommended dose in adults is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Paediatric patients 6 years of age and older weighing at least 20 kg The recommended dose in paediatric patients 6 years of age and older weighing at least 20 kg is shown below in Table 1.
3 Table 1: Recommended dose for paediatric patients 6 years of age and older weighing at least 20 kg Patient population Recommended dose Paediatric patients ≥6 years of age weighing ≥40 kg 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days Paediatric patients ≥6 years of age weighing ≥20 to <40 kg 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together orally every 12 hours for 5 days Special attention for paediatric patients 6 years of age and older weighing at least 20 kg to less than 40 kg There is a pack specific for paediatric patients 6 years of age and older weighing at least 20 kg to less than 40 kg.
This pack contains 5 blister cards with two separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration every 12 hours. Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.
Completion of the full 5-day treatment course is recommended even if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with this medicinal product. If the patient misses a dose 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. Special populations Renal impairment No dose adjustment is needed in patients with mild renal impairment [estimated glomerular filtration rate (eGFR) ≥ 60 to < 90 mL/min].
In adult patients with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min) or with severe renal impairment [eGFR < 30 mL/min, including patients with End Stage Renal Disease (ESRD) under haemodialysis], the dose should be reduced as shown in Table 2 to avoid over-exposure.
The treatment should be administered at approximately the same time each day for 5 days. 2).
Table 2:
Recommended dose and regimen for adult patients with renal impairment 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) every 12 hours Severe renal impairment (eGFR < 30 mL/min) including those requiring haemodialysis 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 Abbreviation: eGFR=estimated glomerular filtration rate.
4 Special attention for patients with MODERATE renal impairment There is a pack specific for patients with moderate renal impairment. This pack contains 5 blister cards with two separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration every 12 hours.
Special attention for patients with SEVERE renal impairment There is a pack specific for patients with severe renal impairment. This pack contains 1 blister card with one separated part containing two tablets of nirmatrelvir and one tablet of ritonavir for administration once on Day 1, and four additional separated parts each containing one tablet of nirmatrelvir and one tablet of ritonavir for administration once daily on Days 2 to 5.
2). Dose in paediatric patients with renal impairment weighing less than 40 kg has not been determined. Hepatic impairment No dose adjustment is needed for patients with either mild (Child-Pugh Class A) or moderate (Child- Pugh Class B) hepatic impairment.
2). Severely immunocompromised population Data are limited in severely immunocompromised individuals. g. 1). Concomitant therapy with ritonavir- or cobicistat-containing regimen No dose adjustment is needed. 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.
Paediatric population The safety and efficacy of Paxlovid in paediatric patients below 6 years of age or weighing less than 20 kg have not been established. 2). Method of administration For oral use. Nirmatrelvir must be coadministered with ritonavir.
Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that […]