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Mechanism of Action  Dosing Dosing Dosing Information Dose Adjustments Drug Interactions Efficacy & Trial Design Efficacy Efficacy Trial Design Safety & Tolerability Support & ResourcesSupport &
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PAXLOVID is indicated for patients* at high risk for progression to severe COVID-19​​​​​​​1Any of the following risk factors can put a patient at risk for progressing to severe COVID-19:
  • Diabetes
  • Overweight (BMI >25)
  • Chronic lung disease (including asthma)
  • Chronic kidney disease**
  • Current smoker
  • Immunosuppressive disease or treatment
  • Cardiovascular disease
  • Hypertension
  • Sickle cell disease
  • Neurodevelopmental disorders
  • Active cancer
  • Medically related technological dependence
  • 60 years of age and older, regardless of comorbidities 
Recommendations in national guidelines may differ from the approved indications.
*Patients is defined as adults who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.1
** In patients with moderate renal impairment (eGFR ≥ 30 to < 60 mL/min), the dose of Paxlovid should be reduced to nirmatrelvir/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].
Efficacy

The efficacy of PAXLOVID was evaluated in 2113 adult COVID-19 patients at high risk for progression to severe disease in the EPIC-HR trial.1,3

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Safety & Tolerability

During the EPIC-HR trial, comparable rates of adverse events were observed between the PAXLOVID and placebo groups.3

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How PAXLOVID Works1,4

PAXLOVID contains nirmatrelvir, a protease inhibitor specifically designed by Pfizer to target the main protease (Mpro), also known as 3-chymotrypsin-like cysteine (3CL) protease enzyme, and to inhibit SARS-CoV-2 replication by preventing proteolysis from occurring. 

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Frequently Asked Questions​​​​​​​

Find answers to frequently asked questions on topics that include early treatment, dosing, and potential drug interactions.  

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▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

References:
  1. PAXLOVID Summary of Product Characteristics. https://www.medicines.ie/medicines/paxlovid-150-mg-100-mg-film-coated-tablets-35210/spc (Accessed October 2023).
  2. Data on File. Pfizer Inc; 2023
  3. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with COVID-19. N Engl J Med. 2022;386(15):1397-1408.
  4. Senger MR, Evangelista TCS, Dantas RF, et al. COVID-19: molecular targets, drug repurposing and new avenues for drug discovery. Mem Inst Oswaldo Cruz. 2020;115:e200254

Legal Category: S1A
Further information is available upon request

PP-PAX-IRL-0114. October 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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