A Conditional Marketing Authorisation (CMA) means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and the product information will be updated as necessary.¹

PAXLOVID is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.¹

The decision to treat to be at the discretion of the treating clinician. The following are risk factors for progression to severe disease:^2,3

• Patients with Down's Syndrome and other chromosomal disorders known to affect immune competence
• Solid cancers
• Solid organ transplant recipients
• Haematological diseases or HSCT recipients
• Immune-mediated inflammatory disorders
• Immune deficiencies 
• Renal disease
  • Paxlovid is contraindicated in patients with severe renal impairment (eGFR < 30 mL/min) or with renal failure as the appropriate dose has not yet been determined¹
• Liver disease
  • Paxlovid is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C)¹
• Neurological disorders
• Respiratory conditions
• HIV / AIDS

PAXLOVID is not authorised for use in paediatric patients. The safety and efficacy of PAXLOVID in patients below 18 years of age have not been established. No data is available.¹

PAXLOVID is a combination of nirmatrelvir and ritonavir. Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that will be insufficient to achieve the desired therapeutic effect. PAXLOVID can be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed. For oral use only.¹

Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (M^pro), also known as 3-chymotrypsin-like cysteine (3CL) protease enzyme. Inhibition of the SARS-CoV-2 M^pro renders the protein incapable of processing polyprotein precursors, which leads to the prevention of viral replication. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, thereby providing increased plasma concentrations of nirmatrelvir. Ritonavir is not active against SARS-CoV-2 3CL protease.¹

Nirmatrelvir exhibited antiviral activity against SARS-CoV-2 infection of dNHBE cells, a primary human lung alveolar epithelial cell line (EC90 value of 181 nM) after Day 3 post‑infection.¹

Ritonavir is administered with nirmatrelvir as a pharmacokinetic enhancer resulting in higher systemic concentrations of nirmatrelvir. Upon repeat-dose of nirmatrelvir/ritonavir 75 mg/100 mg, 250 mg/100 mg, and 500 mg/100 mg administered twice daily, the increase in systemic exposure at steady-state appears to be less than dose proportional. Multiple dosing over 10 days achieved steady-state on Day 2 with approximately twofold accumulation. Systemic exposures on Day 5 were similar to Day 10 across all doses.¹

The most frequently reported adverse reactions from the EPIC-HR trial can be found here.

The safety profile and tolerability data can be found here. 

Anaphylaxis, hypersensitivity reactions and serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with Paxlovid (see section 4.8 of the SmPC).

If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue Paxlovid and initiate appropriate medications and/or supportive care.¹

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 the Google Play or Apple App Store. Adverse Events should also be reported to Pfizer Medical Information on 01304616161

The recommended dosage in adult patients 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. PAXLOVID should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.¹

Completion of the full 5-day treatment course should be decided by at the discretion of the treating HCP if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with PAXLOVID.¹

AM Dose¹

• Two pink 150-mg tablets of nirmatrelvir
• One white 100-mg tablet or ritonavir

Patients should take all 3 tablets together.

PM Dose¹

• Two pink 150-mg tablets of nirmatrelvir
• One white 100-mg tablet or ritonavir

Patients should take all 3 tablets together.

Find more information on dosing here. 

Please consult the GB SmPC for full details on dosing and contraindications before any prescribing decisions are made. 

Please click here for information on Dose Adjustments.

Information about contraindications and interactions with Paxlovid can be found in Section 4 of the GB SmPC. Please consult the GB SmPC for full details on dosing and contraindications before any prescribing decisions are made. 

For the Pfizer Medicines Interactions Checker (GB HCPs only) click here.

Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that will be insufficient to achieve the desired therapeutic effect. PAXLOVID can be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed.¹

PAXLOVID should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.¹

There are no 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.¹

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.¹

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.¹

There are no human data on the use of Paxlovid in breast-feeding.¹

It is unknown whether nirmatrelvir is excreted in human or animal milk, and the effects of it on the breast fed newborn/infant, or the effects on milk production. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breast-fed newborn/infant or the effects of the medicinal product on milk production. A risk to the newborn/infant cannot be excluded. Breast feeding should be discontinued during treatment with Paxlovid and for 7 days after the last dose of Paxlovid.¹

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. The tablets from the missed dose should be disposed of in accordance with local guidelines.¹

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.¹

PAXLOVID is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19.¹

The decision to treat to be at the discretion of the treating clinician. The following are risk factors for progression to severe disease:^2,3,4

• Patients with Down's Syndrome and other chromosomal disorders known to affect immune competence
• Solid cancers
• Solid organ transplant recipients
• Haematological diseases or HSCT recipients
• Immune-mediated inflammatory disorders
• Immune deficiencies 
• Renal disease
  • Paxlovid should not be used in patients with severe renal impairment [eGFR < 30 mL/min, including patients with End Stage Renal Disease (ESRD) under haemodialysis]¹
• Liver disease
  • Paxlovid should not be used in patients with severe hepatic impairment (Child-Pugh Class C)¹
• Neurological disorders
• Respiratory conditions
• HIV / AIDS

PAXLOVID is not authorised for use in paediatric patients. The safety and efficacy of PAXLOVID in patients below 18 years of age have not been established. No data is available.¹

PAXLOVID is a combination of nirmatrelvir and ritonavir. Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that will be insufficient to achieve the desired therapeutic effect. PAXLOVID can be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed. For oral use only.¹

Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (M^pro), also known as 3-chymotrypsin-like cysteine (3CL) protease enzyme. Inhibition of the SARS-CoV-2 M^pro renders the protein incapable of processing polyprotein precursors, which leads to the prevention of viral replication. Ritonavir inhibits the CYP3A-mediated metabolism of nirmatrelvir, thereby providing increased plasma concentrations of nirmatrelvir. Ritonavir is not active against SARS-CoV-2 3CL protease.¹

Nirmatrelvir exhibited antiviral activity against SARS-CoV-2 infection of differentiated normal human bronchial epithelial (dNHBE) cells, a primary human lung alveolar epithelial cell line (EC50 value of 61.8 nM and EC90 value of 181 nM) after 3 days of drug exposure.¹

Ritonavir is administered with nirmatrelvir as a pharmacokinetic enhancer resulting in higher systemic concentrations of nirmatrelvir. Upon repeat-dose of nirmatrelvir/ritonavir 75 mg/100 mg, 250 mg/100 mg, and 500 mg/100 mg administered twice daily, the increase in systemic exposure at steady-state appears to be less than dose proportional. Multiple dosing over 10 days achieved steady-state on Day 2 with approximately twofold accumulation. Systemic exposures on Day 5 were similar to Day 10 across all doses.¹

The most frequently reported adverse reactions from the EPIC-HR trial can be found here.

The safety and tolerability data can be found here. 

Anaphylaxis, hypersensitivity reactions and serious skin reactions (including toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with Paxlovid (see SmPC section 4.8).

If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue Paxlovid and initiate appropriate medications and/or supportive care.¹

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 the Google Play or Apple App Store. Adverse Events should also be reported to Pfizer Medical Information on 01304616161

The recommended dosage in adult patients 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. PAXLOVID should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.¹

Completion of the full 5-day treatment course should be decided by at the discretion of the treating HCP if the patient requires hospitalisation due to severe or critical COVID-19 after starting treatment with PAXLOVID.¹

AM Dose¹

• Two pink 150-mg tablets of nirmatrelvir
• One white 100-mg tablet or ritonavir

Patients should take all 3 tablets together.

PM Dose¹

• Two pink 150-mg tablets of nirmatrelvir
• One white 100-mg tablet or ritonavir

Patients should take all 3 tablets together.

Find more information on dosing here. 

Please consult the NI SmPC for full details on dosing and contraindications before any prescribing decisions are made. 

Please click here for information on Dose Adjustments.

Information about contraindications and interactions with Paxlovid can be found in Section 4 of the NI SmPC. Please consult the NI SmPC for full details on dosing and contraindications before any prescribing decisions are made.

Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that will be insufficient to achieve the desired therapeutic effect. PAXLOVID can be taken with or without food. The tablets should be swallowed whole and not chewed, broken, or crushed.¹

PAXLOVID should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.¹

There are no data on the use of Paxlovid in pregnant women to inform the drug-associated risk of adverse developmental outcomes; women of childbearing potential should avoid becoming pregnant during treatment with Paxlovid and as a precautionary measure for 7 days after completing Paxlovid.¹

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 with Paxlovid, and until one menstrual cycle after stopping Paxlovid.¹

Paxlovid is not recommended during pregnancy and in women of childbearing potential not using contraception unless the clinical condition requires treatment with Paxlovid.¹

There are no data on the use of Paxlovid in breast-feeding women. It is unknown whether nirmatrelvir is present in human or animal milk, and the effects of it on the breast-fed newborn/infant, or the effects on milk production. Breast-feeding should be discontinued during  treatment and as a precautionary measure for 7 days after completing Paxlovid.¹

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. The tablets from the missed dose should be disposed of in accordance with local guidelines.¹

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.¹