Oral COVID-19 Treatments Available Through the Test-and-Treat Initiative & Other COVID-19 Treatments
PAXLOVID (NIRMATRELVIR AND RITONAVIR) EMERGENCY USE AUTHORIZATION PRESCRIPTION
Residents of Skilled Nursing Facilities continued to be impacted by COVID infection despite high levels of vaccination and in many cases, history of prior infection. Mortality rates due to COVID continue to be higher in this patient population. EVERY RESIDENT in a SNF who is infected with COVID should be evaluated for treatment with Paxlovid. Paxlovid is safe and has been shown to lower the risk of hospitalization and death by up to 88% in unvaccinated, and up to 50% in those fully vaccinated or previously infected. Additionally, it has been shown to reduce the risk of long COVID, which may impact the health of the resident well beyond the resolution of acute symptoms. Although there are possible drug interactions, there are resources available to navigate these and many times the medication regimen can be safely adjusted to accommodate Paxlovid treatment. There are no shortages of this medication; it is widely available. Patients who are initially asymptomatic should be reevaluated for treatment if symptoms develop later.
The following criteria should be met for a patient to qualify for treatment with Paxlovid (Nirmatrelvir and Ritonavir) oral therapy for treatment of mild-to-moderate COVID-19 infection under FDA's emergency use authorization they meet ALL of the following criteria:
Positive SARS-CoV-2 test (Confirmation of a positive home rapid SARS-CoV-2 test result with additional direct SARS-CoV-2 viral testing is not required.)
Age ≥ 18 years OR > 12 years of age and weighing at least 40 kg
Symptoms consistent with mild to moderate COVID-192
Are within 5 days of symptom onset
Do NOT have severe renal disease (GFR<30) or severe hepatic impairment (Child-Pugh Class C)
AND are at high risk for severe disease from COVID-19 including hospitalization and/or death, due to one or more of the following risk factors (this is not an all-inclusive list of all possible medical conditions):
Age >65
BMI > 35
Heart conditions (CAD, CHF, Cardiomyopathy, CHD)
Diabetes
Chronic Respiratory disease (if asthma - on daily oral steroid therapy)
Pregnancy
Immunocompromised State
Cancer
Stroke or Cerebrovascular disease (Parkinsons, Dementia)
The patient should NOT need to be hospitalized for their infection and should NOT be requiring oxygen therapy (or increased oxygen therapy from their baseline if already on oxygen chronically)
The patients current medications should be reviewed by the servicing pharmacy to ensure no serious drug-drug interactions.
Dosage: Swallow whole. 300mg nirmatrelvir (two 150mg tablets) with 100mg ritonavir (one 100mg tablet), with all 3 tablets taken together twice daily for 5 days. May be taken with or without food.
Adverse drug reactions: Most common are dysgeusia, diarrhea, hypertension, and myalgia.
Contraindications
Hypersensitivity reactions to the active ingredients (nirmatrelvir or ritonavir) or any other components.
Co-administration with drugs highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions.
Co-administration with potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.
Examples of effected drug classes that are contraindicated include but are not limited to:
Alpha1-adrenoreceptor antagonist: alfuzosin
Analgesics: pethidine, propoxyphene
Antianginal: ranolazine
Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
Anti-gout: colchicine
Antipsychotics: lurasidone, pimozide, clozapine
Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
HMG-CoA reductase inhibitors: lovastatin, simvastatin
PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary arterial hypertension (PAH)
Sedative/hypnotics: triazolam, oral midazolam
For full EUA prescribing information, click here.
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 risk1 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)].
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. § 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—when used to diagnose, prevent, or treat such disease or condition—outweigh 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.
LAGEVRIO (MOLNUPIRAVIR) EMERGENCY USE AUTHORIZATION PRESCRIPTION
The following criteria should be met for a patient to qualify for treatment with Lagevrio (molnupiravir) oral therapy for treatment of mild-to-moderate COVID-19 infection under FDA's emergency use authorization they meet ALL of the following criteria:
Have had a positive COVID-19 test
>18 years of age
Are within 5 days of symptom onset
Should not be pregnant or breast-feeding
AND are at high risk for severe disease from COVID-19 including hospitalization and/or death, due to one or more of the following risk factors (this is not an all-inclusive list of all possible medical conditions):
Age >65
BMI > 35
Heart conditions (CAD, CHF, Cardiomyopathy, CHD)
Diabetes
Chronic Respiratory disease (if asthma - on daily oral steroid therapy)
Pregnancy
Immunocompromised State
Cancer
Stroke or Cerebrovascular disease (Parkinsons, Dementia)
The patient should NOT need to be hospitalized for their infection and should NOT be requiring oxygen therapy (or increased oxygen therapy from their baseline if already on oxygen chronically)
Dosage: Swallow whole. 800mg (four 200mg capsules) taken orally every 12 hours for 5 days. May be taken with or without food.
Adverse drug reactions: Most common include diarrhea, nausea, and dizziness.
Contraindications
No contraindications have been identified based on the limited available data on the emergency use of LAGEVRIO authorized under this EUA.
For full EUA prescribing information, click here.
MANDATORY REQUIREMENTS FOR ADMINISTRATION OF LAGEVRIO UNDER EMERGENCY USE AUTHORIZATION
In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of LAGEVRIO, the following steps are required. Use of LAGEVRIO under this EUA is limited to the following (all requirements must be met):
Treatment of mild-to-moderate COVID-19 in adults with a positive result of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
As the prescribing healthcare provider, review the information contained within the “Fact Sheet for Patients and Caregivers” with your patient or caregiver prior to the patient receiving LAGEVRIO. Healthcare providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving LAGEVRIO and must document that the patient/caregiver has been given an electronic or hard copy of the “Fact Sheet for Patients and Caregivers”.
3. The prescribing healthcare providers must inform the patient/caregiver that:
LAGEVRIO is an unapproved drug that is authorized for use under this Emergency Use Authorization.
Other therapeutics are currently approved or authorized for the same use as LAGEVRIO. [see Emergency Use Authorization (1) - Information Regarding Available Alternatives for the EUA Authorized Use].
There are benefits and risks of taking LAGEVRIO as outlined in the “Fact Sheet for Patients and Caregivers.”
Merck Sharp & Dohme has established a pregnancy surveillance program.
Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for 4 days after the last dose of LAGEVRIO.
Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least 3 months after the last dose.
4. The prescribing healthcare provider must assess whether a female of childbearing potential is pregnant or not, if clinically indicated.
5. Based on findings from animal reproduction studies, LAGEVRIO may cause fetal harm when administered to pregnant individuals. If LAGEVRIO is used during pregnancy, prescribing healthcare providers must communicate to the patient the known and potential benefits and the potential risks of LAGEVRIO use during pregnancy, as outlined in the “Fact Sheet for Patients and Caregivers”
6. If the decision is made to use LAGEVRIO during pregnancy, the prescriber must document that the known and potential benefits and the potential risks of LAGEVRIO use during pregnan ts and Caregivers,” were discussed with the patient.
7. The prescribing healthcare provider must document that a pregnant individual was made aware of Merck Sharp & Dohme’s pregnancy surveillance program at 1-877-888-4231 or pregnancyreporting.msd.com.
If the pregnant individual agrees to participate in the pregnancy surveillance program and allows the prescribing healthcare provider to disclose patient specific information to Merck Sharp & Dohme, the prescribing healthcare provider must provide the patient’s name and contact information to Merck Sharp & Dohme.
8. The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to LAGEVRIO within 7 calendar days from the healthcare provider’s awareness of the event.
Non-Oral Therapeutics
VEKLURY
VEKLURY (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are:
Hospitalized, or
Not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days.
Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of VEKLURY 200 mg on Day 1 followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 via intravenous infusion. The treatment course of VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made.
Administer VEKLURY via intravenous (IV) infusion over 30 to 120 minutes.
VEKLURY is not recommended in patients with CrCl less than 30 mL/min.
Hypersensitivity including infusion-related and anaphylactic reactions: Slower infusion rates, with a maximum infusion time of up to 120 minutes, can be considered to potentially prevent signs and symptoms of hypersensitivity. Monitor patients during infusion and observe patients for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. If signs and symptoms of a clinically significant hypersensitivity reaction occur, immediately discontinue administration of VEKLURY and initiate appropriate treatment.
Remdesivir may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
For full prescribing information, click here.
BEBTELOVIMAB
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of bebtelovimab for the 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, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
LIMITATIONS OF AUTHORIZED USE
Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.
FDA’s determination and any updates will be available at: https://www.fda.gov/emergencypreparedness-and-response/mcm-legal- regulatory-and-policy-framework/emergency-useauthorization#coviddrugs.
Bebtelovimab is NOT authorized for use in patients, who:
are hospitalized due to COVID-19, OR
require oxygen therapy and/or respiratory support due to COVID-19, OR
require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19 and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The dosage in adults (18 years and older) and pediatric patients (≥12 years of age and weighing at least 40 kg) is bebtelovimab 175 mg.
Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds.
No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, in individuals with renal impairment, or in individuals with mild hepatic impairment.
Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. If clinically significant hypersensitivity reactions occur, discontinue and initiate appropriate supportive care. Infusion-related reactions may occur up to 24 hours post injection.
These reactions may be severe or life threatening.
For full EUA prescribing information, click here (link opens in a new window).
For COVID-19 therapeutics locator by Department of Health and Human Services, visit the link here.