PAXLOVID Film-coated tablet Ref.[49622] Active ingredients: Nirmatrelvir Nirmatrelvir and Ritonavir Ritonavir

Posology

The recommended dosage is 300 mg PF-07321332 (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. 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 Paxlovid.

If the patient misses a dose of Paxlovid 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 (eGFR ≥60 to <90 mL/min). In patients with moderate renal impairment (eGFR ≥30 to <60 mL/min), the dose of Paxlovid should be reduced to PF-07321332/ritonavir 150 mg/100 mg every 12 hours for 5 days to avoid over-exposure (this dose adjustment has not been clinically tested). 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] (see sections 4.4 and 5.2).

Special attention for patients with moderate renal impairment

The daily blister contains two separated parts each containing two tablets of PF-07321332 and one tablet of ritonavir corresponding to the daily administration at the standard dose. Therefore, patients with moderate renal impairment should be alerted on the fact that only one tablet of PF-07321332 with the tablet of ritonavir should be taken every 12 hours.

Hepatic impairment

No dose adjustment of Paxlovid is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Paxlovid should not be used in patients with severe hepatic impairment (see sections 4.4 and 5.2).

Concomitant therapy with ritonavir- or cobicistat-containing regimen

No dose adjustment of Paxlovid 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 patients below 18 years of age have not been established. No data are available.

Method of administration

For oral use.

PF-07321332 must be coadministered with ritonavir. Failure to correctly coadminister PF-07321332 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, as no data is currently available.

Treatment of overdose with Paxlovid should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with Paxlovid.

1 year.

Do not store above 25°C. Do not refrigerate or freeze.

OPA/Al/PVC foil blister cards of 30 tablets.

Paxlovid is packaged in cartons containing 5 daily-dose blister cards of 30 tablets.

Each daily blister card contains 4 PF-07321332 tablets and 2 ritonavir tablets for morning and evening dose.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.