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Oral Agents for the Treatment of COVID-19
December 27, 2021
The Food and Drug Administration (FDA) last week issued emergency use authorizations (EUA) for the use of Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use), and Merck’s Molnupiravir, for treatment of COVID-19.
 
  • Patients eligible for treatment with Paxlovid or Molnupiravir are those who have mild-to-moderate COVID-19 and are at high risk for progression to severe disease.
  • Because of Molnupiravir’s lower effectiveness, it should not be used for treatment in patients where either Paxlovid or anti-SARS-CoV-2 monoclonal antibodies are available and clinically appropriate.
  • Paxlovid is authorized for adults and pediatric patients (12 years of age and older weighing at least 40 kilograms). Providers should review the FDA’s Paxlovid Fact Sheet for additional information on the use of this drug.
  • Molnupiravir is authorized for adults 18 years and older but is not recommended for use during pregnancy or breast feeding. Providers should review the FDA’s Molnupiravir Fact Sheet for additional information on the use of this drug.
 
These drugs may only be prescribed by physicians, advanced practice registered nurses, and physician assistants who are licensed or authorized under state law to prescribe drugs in the therapeutic class to which these agents belong (i.e., antiinfectives).
Initial Distribution of Paxlovid and Molnupiravir
Initial supplies of these products will be directed by the federal government and will be extremely limited for the next several weeks. Orange County’s initial distribution will be allocated to CVS and Rite Aid pharmacies. OCHCA will provide additional distribution information as it becomes available.
 
The California Department of Public Health (CDPH) released Health Alerts on Paxlovid and Molnupiravir which include guidance on prioritizing patients for these drugs as well as ethical considerations for treatment given supply limitations.
Guidance for the Public
For questions or concerns, please contact the Communicable Disease Control Division at 714-834-8180.
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