Prescribing Information for ▼PAXLOVID (nirmatrelvir / ritonavir) can be found here. Adverse event reporting information can be found at the bottom of the page.
Paxlovid has a Conditional Marketing Authorisation in the United Kingdom. A Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed when any relevant information of significance becomes available and at least every year and the product information will be updated as necessary.
Please consult the SmPC for full details on dosing and contraindications before any prescribing decisions are made.
Renal Adjustments
No dosage adjustment is needed 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 haemodialysis, 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 haemodialysis, the Paxlovid dose should be administered after haemodialysis.
|
Table 1: Recommended dose and regimen for patients with renal impairment |
||
|
Renal function |
Days of treatment |
Dose and dose frequencya |
|
Moderate renal impairment |
Days 1-5 |
150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) twice daily |
|
Severe renal impairment |
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. a. Paxlovid should be administered at approximately the same time each day for 5 days. b. On days of hemodialysis, the Paxlovid dose should be administered after hemodialysis. |
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Elderly population
No dose adjustment is recommended for elderly patients.
Paediatric population
The safety and efficacy of Paxlovid in patients below 18 years of age have not been established. No data are available.
HIV resistance
As nirmatrelvir is coadministered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.
Pregnancy
There are limited data from the use of Paxlovid in pregnant women. Paxlovid should be used during pregnancy only if the potential benefits outweigh the potential risks for the mother and the foetus.
Women of childbearing potential
There are limited human data on the use of Paxlovid during pregnancy to inform the drug-associated risk of adverse developmental outcomes. Women of childbearing potential should avoid becoming pregnant during treatment with Paxlovid.
Contraception in males and females
Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Patients using combined hormonal contraceptives should be advised to use an effective alternative contraceptive method or an additional barrier method of contraception during treatment and until after one complete menstrual cycle after stopping Paxlovid.
Breast feeding
Paxlovid is excreted in breastmilk in small amounts. There are no data on the effects of nirmatrelvir or ritonavir on the breast-fed newborn/infant or on breast milk production. A risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued during treatment with Paxlovid and for 48 hours after the last dose of Paxlovid.
Discover the trial design and efficacy data of EPIC-HR.
Explore downloadable materials to further support both you and your patients.
Learn about the safety profile and tolerability of PAXLOVID.
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Reference:
1. PAXLOVID Summary of Product Characteristics. Pfizer Inc.
Adverse Events
Adverse Events should be reported. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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