COVID-19 Therapeutics – Alabama Department of Public Health

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.

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 progressions to severe COVID-19 disease
  • Those who are not hospitalized due to COVID 19 disease
  • Persons age 12 years and above may be eligible for nirmatrelvir/ritonavir
  • Persons age 18 years or older may be eligible for molnupiravir

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 the 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

Additional Paxlovid Resources

Molnupiravir

Prior to prescribing molnupiravir, review the following:

  • Date of onset of symptoms since the treatment needs to start within 5 days from the beginning of symptoms
  • Age of patient – must be at least 18 years old
  • Assess patient’s risk of progression to severe COVID-19 disease
  • Confirmation of a positive test for SARS-CoV-2

For females of childbearing potential being considered for molnupiravir:

Assess whether pregnant or not (based on report of last menstrual period in individual with regular menstrual cycles and using reliable contraception correctly and consistently or based on a negative pregnancy test).

If pregnant:

Counsel patient regarding known and potential risks and benefits of molnupiravir use during pregnancy and document that patient is aware.

Counsel patient on the pregnancy surveillance program and provide patient name and contact information to Merck, if the patient agrees (at 877-888-4231 or Report a Pregnancy Exposure.

If not pregnant:

Recommend using effective contraception during treatment and for four days after the last dose.

If breastfeeding:

Confirm education has been provided that breastfeeding is not recommended during treatment and for four days after the last dose of molnupiravir. Recommend interrupting breastfeeding or pumping and discarding breast milk during treatment and for four days after the last dose of molnupiravir.

For males being considered for treatment with molnupiravir:

Confirm education has been provided recommending sexually active individuals with partners of childbearing age use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose of molnupiravir.

Additional Molnupiravir Resources

Veklury and Bebtelovamib

For information concerning Veklury and Bebtelovamib, see NIH Guidelines and the Bebtelovamib EUA Fact Sheet.

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.

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