Nirmatrelvir with Ritonavir (Paxlovid)

• Indication: Treatment
• Administration: Oral twice daily for 5 days
• Patient Age: 12 years and older
• Paxlovid is approved for people ages 18 and older and is available under EUA for people ages 12-17
• FDA Fact Sheets:
  • Paxlovid Approved Label (PDF)
  • Paxlovid Fact Sheet for Providers (PDF)
  • Paxlovid Fact Sheet for Patients, Parents and Caregivers (PDF)
  • Paxlovid Checklist Tool for Prescribers (PDF)

Molnupiravir (Lagevrio)

• Indication: Treatment
• Administration: Oral twice daily for 5 days
• Patient Age: 18 years and older
• FDA Fact Sheets:
  • Molnupiravir Fact Sheet for Providers (PDF)
  • Molnupiravir Fact Sheet for Patients, Parents and Caregivers (PDF)
  • Molnupiravir Checklist Tool for Prescribers (PDF)

Remdesivir (Veklury)

• Indication: Treatment
• Administration: Three (3) daily Intravenous infusions
• Patient Age: 28 days of age and older
• FDA Documentation:
  • Veklury Label Sheet (PDF)
  • Manufacturer Website for Patients

Antivirals are available for people who have tested positive for SARS-CoV-2, regardless of their vaccination status.

• Paxlovid is the preferred treatment for most outpatients aged 12 and older.
• Intravenous Veklury (remdesivir) is recommended for patients younger than 12 years of age or for those unable to take Paxlovid.
• Lagevrio (molnupiravir) is authorized for use in people ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Oral antivirals are available for people who meet all of the following conditions:

• Are age 12 years and older and weigh at least 88 pounds for Paxlovid; 18 years and older for Lagevrio (molnupiravir)
• Have mild to moderate COVID-19 symptoms
• Are able to start treatment within five days of symptom onset
• Are not hospitalized due to severe or critical COVID-19 when treatment is initiated
• Have at least one risk factor for progression to severe COVID-19, including:
• Age 50 years or older, with risk increasing substantially for those 65 years and older
• Being unvaccinated or not being up to date on COVID-19 vaccinations
• Have a medical condition or other factors that increase their risk for severe COVID-19 illness

Intravenous Veklury (remdesivir) is approved for people who meet all of the following conditions:

• Are an adult or pediatric patient (28 days or older and weighing more 3 kg or 6.6 lb)
• Have mild to moderate COVID-19 symptoms
• Test positive for SARS-CoV-2 on a nucleic acid amplification test or antigen test.
• Are able to start treatment within seven days of symptom onset
• Are hospitalized or not hospitalized
• Have at least one risk factor for progression to severe COVID-19, including:
• Age 50 years or older, with risk increasing substantially for those 65 years and older
• Being unvaccinated or not being up to date on COVID-19 vaccinations
• Have a medical condition or other factors that increase their risk for severe COVID-19 illness

Providers can use HHS's COVID-19 Decision Support Tool (PDF, December 2022) to support their clinical decisions.

Oral antiviral treatment must be administered within five days of symptom onset, but it is most effective the sooner patients begin. Treatment should be offered to any eligible patient at higher risk for severe COVID-19, regardless of vaccination status (Shaw, 2022).

For Paxlovid Only

Paxlovid is the preferred treatment for eligible patients ages 12 years and older.

Contraindications and Precautions

Paxlovid can alter the concentrations of other drugs, so it is important to assess for potential drug-drug interactions. Approved label includes a boxed warning with instructions for prescribers. Several resources are available on steps that can be taken to avoid significant interactions with commonly prescribed medications, such as brief suspension or dose reduction of other medications. Do not prescribe Paxlovid for patients who are taking rivaroxaban or salmeterol; avoid it in patients with severe renal impairment (eGFR <30).

Paxlovid is not recommended for patients with severe kidney (eGFR <30 mL/min) or liver (Child-Pugh Class C) impairment.

Special renal dose packs (Paxlovid 150 mg; 100 mg) are available for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min).

Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated.

The following resources are available to assess and manage potential drug-drug interactions:

• NIH Treatment Guidelines Statement on Potential Paxlovid Drug-Drug Interactions
• Paxlovid Fact Sheet for Health Care Providers (PDF)
• Paxlovid Checklist Tool for Prescribers (PDF)
• Liverpool Drug Interactions Tool, including downloadable phone app
• Assessing a patient for treatment with Paxlovid (PDF)
• Infectious Diseases Society of America:
• Management of Drug Interactions with Nirmatrelvir/Ritonavir: Resource for Clinicians
• Paxlovid for Treatment of COVID-19: Considerations for People with HIV and Hepatitis C.
• Ontario COVID-19 Science Advisory Table: What Prescribers and Pharmacists Need to Know

The following strategies can facilitate the use of Paxlovid in special populations:

• Although Paxlovid is not recommended in patients with a renal function of eGFR <30 mL/min, based on limited data, some groups have proposed dose adjustments in patients with eGFR <30 or on hemodialysis (NIH Treatment Guidelines).
• Patients receiving calcineurin and mammalian target of rapamycin inhibitors may be prescribed if a drug interaction expert is available and close therapeutic drug monitoring is logistically feasible (American Society of Transplantation’s statement)
• In patients receiving chemotherapy, interactions should be managed with specialist providers. Guidance on managing chemotherapy interactions can be accessed at the FDA EUA fact sheet and the University Health Network/Kingston Health Sciences Centre resource.

For Lagevrio (molnupiravir) Only

Lagevrio should be prescribed for patients ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Precautions

Lagevrio is not recommended during pregnancy. Prescribing providers should advise individuals of childbearing potential to use effective contraception correctly and consistently for the duration of treatment and for four days after the last dose of Lagevrio.

Breastfeeding is not recommended during treatment and for four days after the last dose of Lagevrio. A lactating individual may consider interrupting breastfeeding and pumping and discarding breast milk during this time.

Men of reproductive potential who are sexually active with women of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose.

For more information, see the Lagevrio Fact Sheet for Providers (PDF) and the FDA Lagevrio Checklist Tool for Prescribers (PDF).

For Veklury (remdesivir) Only

Veklury (remdesivir) is available for adults and children 28 days and older. It is administered daily for 3 consecutive days via intravenous infusion and treatment should start within 7 days of symptoms onset.

Contraindications and Precautions

Therapy is contraindicated for patients with a history of clinically significant hypersensitivity reactions to its active ingredients or any other components of the product.

Veklury is not recommended for patients with severe kidney disease (eGFR <30 mL/min), though data suggest it can be used in patients with an eGFR of <30 mL/min if the potential benefits outweigh the risks. (NIH Treatment Guidelines)

Prior to initiating treatment with Veklury, the FDA recommends performing renal function (eGFR), liver function, and prothrombin time tests as clinically appropriate and repeating these tests during treatment as clinically indicated.

For more information, see the Veklury Label Sheet (PDF)

COVID-19 Rebound

COVID-19 rebound is the term used describe a recurrence of symptoms or SARS CoV-2 antigen positivity, which can occur between 2 and 8 days after initial recovery. Recent studies suggest that patients who experience rebound have an extremely low probability of developing severe COVID-19. Retreatment is not currently recommended. The potential for COVID-19 rebound after antiviral treatment is not a reason to avoid prescribing.

People with rebound can transmit to others, and patients should re-isolate for at least 5 days from the recurrence of symptoms per CDC guidance. It is important to advise your patients that COVID-19 rebound does not represent a failure of treatment or resistance.

Paxlovid and Lagevrio (molnupiravir) are available in pharmacies throughout NYC. Visit the COVID-19 Therapeutics Locator or the Test to Treat Locator to find the nearest location. See below for instructions on how to send a prescription to Alto Pharmacy for free home delivery to patients.

Oral antivirals can only be prescribed by a physician, advanced practice registered nurse or physician assistant. Paxlovid can also be prescribed by pPharmacists with certain limitations. For more information on prescribing Paxlovid, see the Paxlovid Checklist Tool for Prescribers (PDF).

Prescriptions placed with Alto Pharmacy will be delivered the same or next day to the patient’s preferred address at no cost.

• Once the prescription is placed, patients can schedule their delivery on the Alto mobile app, by text or by phone with Alto pharmacists.
• Alto Pharmacy can offer direct support in English and Spanish and support in numerous other languages through a language line.
• Prescriptions confirmed by 5 p.m. on weekdays or 1 p.m. on weekends will be delivered the same day.

Complete the following steps to prescribe an oral antiviral medication for a patient:

1. Add Alto Pharmacy to your electronic health record (EHR) system for e-prescribing. To locate Alto Pharmacy in your ePrescribing platform or EHR, search by:
   • Name: Alto Pharmacy
   • Address: 100 Park Avenue, Front E, New York, NY 10017
   • NPI: 1417578899
   • NCPDP: 5831866
     
     If you are having trouble finding Alto Pharmacy, check search filters to remove mileage or radius limits and "favorites" or "recently viewed" filters.
     
     Alternatively, Alto Pharmacy accepts prescriptions by phone at 800-874-5881, or by fax at 415-484-7058.


2. Verify patient’s phone number and address for delivery.


3. Choose the oral antiviral you would like to prescribe, Paxlovid or Lagevrio (molnupiravir) should only be prescribed for patients for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate).
   
   • For patients with moderate renal dysfunction (eGFR ≥30 to <60mL/min), specify dosing for the renal dose pack: 150 mg nirmatrelvir (one 150 mg tablet) with 100 mg ritonavir (one 100 mg tablet) taken together twice daily for five days.


4. In the note for pharmacist section, indicate the patient’s date of symptom onset.


5. Submit prescription to Alto Pharmacy.


6. Advise patient that they will receive a call or text message from the pharmacy (800-874-5881) and they must respond to schedule the delivery. More information is available at the Alto Pharmacy website.


7. Contact Alto Pharmacy at 800-874-5881 for questions on medicine interactions or other concerns.

Veklury can be given in skilled nursing facilities, home health care settings and outpatient facilities such as infusion centers as long as severe hypersensitivity reactions, such as anaphylaxis, can be managed.

Veklury (remdesivir) is commercially available through Gilead Pharmaceuticals and multiple distributors such as AmerisourceBergen, Cardinal, or McKesson. To order, non-hospitals can contact AmerisourceBergen Specialty Distribution by calling 1-800-746-6273 or emailing remdesivir@AmerisourceBergen.com. Visit vekluryhcp.com for coding and reimbursement information and gileadadvancingaccess.com for patient assistance resources.

Facilities and providers that see large numbers of immunosuppressed patients (such as transplant and oncology centers), high-risk pediatric populations, or other patients for whom Paxlovid may not be clinically appropriate are encouraged to offer Veklury in the outpatient setting. This can be done in collaboration with tertiary care centers.

Patients can also visit ExpressCare or call 212-COVID19 (212-268-4319) or 311 for a treatment evaluation and to schedule an appointment for remdesivir infusions if indicated through NYC Health + Hospitals.

People at increased risk of severe COVID-19 and their caregivers should be advised:

• About the benefits of prompt oral antiviral treatment to reduce the risk of hospitalization and death
• To immediately get tested if they develop COVID-19 symptoms or were recently exposed
• To contact their provider right away if they test positive
• That COVID-19 rebound is generally mild and does not represent a treatment failure or resistance
• To develop a COVID-19 action plan so that all information needed is on hand if they or a member of their household gets sick with COVID-19

Patients who do not have a health provider or are uninsured can visit ExpressCare or call 212-COVID19 (212-268-4319) or 311 to speak with a doctor about treatment options or find a Test to Treat site at nyc.gov/covidtest or aspr.hhs.gov/TestToTreat.

HHS: What Are Oral Antivirals

Patient Handout: COVID-19 Treatments Are Available (PDF)

Palm Card:Treatment for COVID-19 (PDF, January)
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