NIRMATRELVIR AND RITONAVIR (Paxlovid) Nursing Considerations

What is the generic name?

NIRMATRELVIR AND RITONAVIR

What is the Trade Name for NIRMATRELVIR AND RITONAVIR?

Paxlovid

What are the Indications for NIRMATRELVIR AND RITONAVIR?

• 1 EMERGENCY USE AUTHORIZATION The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient. for progression to severe COVID-19, including hospitalization or death. LIMITATIONS OF AUTHORIZED USE PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19 [see Dosage and Administration (2.1) ] . Patients requiring hospitalization due to severe or critical COVID-19 after starting treatment with PAXLOVID may complete the full 5-day treatment course per the healthcare provider’s discretion. PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19. PAXLOVID is not authorized for use for longer than 5 consecutive days. PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives). PAXLOVID is not approved for any use, including for use for the treatment of COVID-19. PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under section 564(b)(1) of the Act, 21 U.S.C. ¬ß 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Justification for Emergency Use of Drugs During the COVID-19 Pandemic There is currently an outbreak of COVID-19 caused by SARS-CoV-2, a novel coronavirus. The Secretary of Health and Human Services (HHS) has declared that: A public health emergency related to COVID-19 has existed since January 27, 2020. Circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic (March 27, 2020 declaration). An EUA is a U.S. Food and Drug Administration authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include: The biological agent(s) can cause a serious or life-threatening disease or condition; Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and the known and potential benefits of the product‚Äîwhen used to diagnose, prevent, or treat such disease or condition‚Äîoutweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s); There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition. Information Regarding Available Alternatives for the EUA Authorized Use Veklury (remdesivir) is FDA-approved for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days. Although Veklury is an approved alternative treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) 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, FDA does not consider Veklury to be an adequate alternative to PAXLOVID for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires an intravenous infusion daily for 3 days). Other therapeutics are currently authorized for the same use as PAXLOVID. For additional information on all products authorized for treatment or prevention of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. For information on clinical studies that are testing the use of PAXLOVID in COVID-19, please see www.clinicaltrials.gov.

References: https://open.fda.gov/