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COVID-19 Therapeutics for Healthcare Providers

With COVID-19 continuing to circulate in Alabama, it is crucial that providers be aware of current treatment guidelines from the National Institutes of Health (NIH) and the CDC. Along with guidelines regarding the best options for treatment comes the concern that therapeutics be used safely. Treatment of organ transplant recipients with chronic immunosuppression requires a very high level of caution in prescribing antivirals, including carefully reviewing information regarding drug-drug interactions. Clinicians should be aware of indications, appropriate dosing, and precautions regarding the use of therapeutics for all patients.

UAB has partnered with ADPH providing the document, UAB Medicine Paxlovid Guidance for Drug Interaction Management, as part of ongoing efforts to assist clinicians. Additional information and links are included on this page and should be thoroughly reviewed as part of patient safety.

Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program

The government-purchased distribution program for Paxlovid and Lagevrio, antivirals for the treatment of mild to moderate COVID-19 disease, has ended but these medications remain available by prescription at local pharmacies and other healthcare facilities. Patients and healthcare professionals should contact their insurance company to determine coverage.

Copay assistance for Paxlovid is available through Pfizer’s PAXCESS Program. Enrollment can be done online or by calling 877-219-7225. In addition, anyone uninsured or covered by federal programs, such as Medicare or Medicaid, can receive government-purchased Paxlovid at no cost through the Paxlovid Patient Assistance Program. When approved, dispensing sites will be reimbursed for dispensed Paxlovid plus a dispensing fee. Retail pharmacies can learn more about this program by emailing the program vendor, [email protected]. This program is scheduled to end on December 31, 2024.

The Lagevrio Patient Assistance Program is only available through an urgent need request. To enroll, patients must call 800-727-5400 to receive instructions on how to complete and submit the online enrollment form. More information including eligibility requirements is available at MerckHelps.

A COVID-19 Treatment Locator, combining Test to Treat locations and therapeutic providers, is available for healthcare providers and patients.

The Paxlovid Emergency Use Authorization (EUA) Letter of Authorization has been updated by the Food and Drug Administration to include a termination date of March 8, 2024, for Paxlovid distributed by the U.S. Government. Any government purchased product remaining in inventory should be returned via Pfizer’s returns process. Information can be requested by sending an email to [email protected] or calling 877-740-6148.

Read more about the transition of Paxlovid and Lagevrio to the commercial market.

Quicklinks

Eligibility for Outpatient Therapeutics

Persons eligible for outpatient therapeutics include:

  • Those who have tested positive for SARS-CoV-2 (PCR or antigen) within 5 days of symptom onset
  • Those who have symptoms consistent with mild to moderate COVID-19
  • Those who are at risk for progression to severe COVID-19 disease
  • Those who are not hospitalized due to COVID-19 disease
  • Persons aged 12 years and above may be eligible for nirmatrelvir/ritonavir

Paxlovid (nirmatrelvir/ritonavir)

Prior to prescribing Paxlovid (nirmatrelvir/ritonavir), review the following:

  • Date of onset of symptoms since the treatment needs to start within 5 days from the beginning of symptoms
  • The age of patient - must be at least 12 years old
  • Patient's risk of progression to severe COVID-19 disease
  • Confirmation of a positive test for SARS-CoV-2

Determine dosing and make adjustments for renal impairment:

  • Mild impairment (eGFR higher than 60, but lower than 90 ml/min): No change.
  • Moderate impairment (eGFR higher than 30, but lower than 60 ml/min): Reduce regular dose to 150 mg of nirmatrelvir (one 150 mg tablet) with 100 mg of ritonavir (one 100 mg tablet), taken together twice daily for five days.
  • Severe impairment (eGFR lower than 30 ml/min): Paxlovid is NOT recommended.

Determine dosing and make adjustments for hepatic impairment:

  • Mild to moderate impairment: No dose adjustment needed.
  • Severe impairment (Child-Pugh Class C or higher - Paxlovid NOT recommended). View Score Calculator.

Review the patient's medication regimen, including over-the-counter medications, herbal supplements, and any recreational drugs, for potentially serious drug interactions. View Drug Interactions Between Ritonavir-Boosted Nirmatrelvir (Paxlovid) and Concomitant Medications.

Drug classes of particular concern are those that include drugs that are prone to concentration-dependent toxicities, including certain antiarrhythmics, oral anticoagulants, immunosuppressants, anticonvulsants, antineoplastics, and neuropsychiatric drugs.

If the patient is taking any medication(s) that are contraindicated for co-administration with Paxlovid:

Consider specialist review (e.g., HIV provider, transplant provider, specialist pharmacist) for patients receiving highly specialized therapies, such as immunosuppressants or antineoplastics.

Strategies for management of the concomitant medication may include dose adjustment, use of an alternative agent, increased monitoring, or temporary withholding. Note: the dose of Paxlovid should not be adjusted to avoid a drug interaction.

In settings where using these management strategies is not feasible, or where the effectiveness of ritonavir-boosted nirmatrelvir may be compromised, consider using alternative COVID-19 therapies.

For patients ages 12-17 years being considered for treatment with Paxlovid:

The same eligibility considerations as above apply, plus: confirm weight is more than 40 kg (about 88 lbs).

View additional information for pediatric patients with high-risk conditions.

Pharmacists Prescribing Paxlovid

On July 6, 2022, in a letter to Pfizer, Inc from the FDA, the FDA has now concluded that a pharmacist may prescribe Paxlovid only pursuant to strict compliance with certain conditions. While it is your responsibility to read and understand the entirety of the referenced letter, the Board directs your specific attention to the following portions appearing on page 4 of the letter.

  • PAXLOVID may also be prescribed for an individual patient by a state-licensed pharmacist under the following conditions:
    • Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function; and 
    • Sufficient information is available, such as through access to health records, patient reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient, to obtain a comprehensive list of medications (prescribed and nonprescribed) that the patient is taking to assess for potential drug interactions.
  • The use of PAXLOVID covered by this authorization must be in accordance with the authorized Fact Sheets.
Read the full FDA-updated EUA for Paxlovid.
Additional Paxlovid Resources

 

Report Medication Errors and Serious Adverse Events

Prescribing healthcare providers and/or designees must report all medication errors and serious adverse events potentially related to these medications to the FDA MedWatch within 7 calendar days from the healthcare provider’s awareness of the event.





Page last updated: February 1, 2024