Paxlovid Emergency Use Authorization (EUA)

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for PAXLOVID for the treatment of mild-to-moderate COVID-19 in eligible high-risk patients who have been diagnosed with SARS-CoV-2 and who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants

Should the patient require hospitalization due to severe or critical COVID-19 after starting treatment with PAXLOVID, the patient should complete the full 5-day treatment course per the health care provider's discretion. 

Prescribers must comply with requirements of the US Food and Drug Administration's Factsheet for Healthcare Providers Emergency Use Authorization for Paxlovid™ and with the State of Michigan Priority Eligibility Criteria and prescribing requirements for this medication. Patients must have tested positive for SARS-CoV-2.

 

PAXLOVID is indicated for the treatment of mild-to-moderate (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), and

  • with positive results of direct (SARS-CoV-2) viral testing, and
  • who are at high risk for progression to severe COVID-19, including hospitalization or death, and
  • who meet the current Michigan Priority Eligibility Criteria. 
  • Immunocompromised patients who have received Evusheld for pre-exposure prophylaxis currently should not receive Paxlovid based on scarce resource allocation principles.

 

Dosing of PAXLOVID (see full Fact Sheet for Healthcare Providers)

PAXLOVID is nirmatrelvir tablets co-packaged with ritonavir tablets. Nirmatrelvir must be co-administered with ritonavir.

  • Initiate PAXLOVID treatment as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
  • Administer orally with or without food.
  • Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for 5 days.
  • Dose reduction for moderate renal impairment (eGFR ≥30 to <60 mL/min): 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet), with both tablets taken together twice daily for 5 days.
  • PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min).
  • PAXLOVID is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).
  • Alert the patient of the importance of completing the full 5-day treatment course and to continuing isolation in accordance with public health recommendations to maximize viral clearance and minimize transmission.

 

Dosage Forms of PAXLOVID

  • Tablets: nirmatrelvir 150 mg 
  • Tablets: ritonavir 100 mg

 

Warning and Precautions for PAXLOVID

  • The concomitant use of PAXLOVID and certain other drugs may result in potentially significant drug interactions that could result in serious, life-threatening adverse events. Consult the full prescribing information prior to and during treatment for potential drug interactions.
  • Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir.
  • HIV-1 Drug Resistance: PAXLOVID use may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

 

Contraindications for PAXLOVID

  • History of clinically significant hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components.
  • Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.
  • Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.

 

Warning and Precautions

There is insufficient human data on Paxlovid in pregnancy. See the Fact Sheet for additional information. Paxlovid should be used with caution in pregnancy and only when mAb therapy is unavailable and after full discussion with the patient of potential risks and benefits.

 

Medication Interactions and Potential for Severe Adverse Events with PAXLOVID

Co-administration of PAXLOVID can alter the plasma concentrations of other drugs and other drugs may alter the plasma concentrations of PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy and review concomitant medications during PAXLOVID therapy.

 

All adverse reactions and medication errors must be reported to the FDA using FDA form 3500 FDA ADVERSE REACTIONS. In addition, Pfizer requires adverse reactions and medication errors be reported at www.pfizersafetyreporting.com.