MOLNUPIRAVIR CAP,ORAL

Clinical Criteria Summary

Adverse reactions: diarrhea, nausea, dizziness
MOVe-OUT trial data: Death or hospitalization by day 29 was 6.8% (MOV) vs. 9.7% (placebo)

Not recommended in pregnancy and lactation due to potential embryo-fetal toxicity based on animal data
If used, requires extensive discussion/documentation
Requires reliable, consistent contraception during therapy and for 4 days after last dose in females of childbearing potential
Requires reliable, consistent contraception for 3 months after last dose in males of reproductive potential

Treatment of mild to moderate laboratory confirmed COVID-19 in individuals 18 years of age and older
Positive results of direct SARS-CoV-2 viral testing
At high risk for progressing to severe disease
Within 5 days of symptom onset
Alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate (remdesivir is not considered an adequate alternative under the EUA due to IV infusion requirements, though NIH guidelines list it as a priority option)

Age ≥ 65 years
Cancer
Chronic kidney disease
Chronic liver disease
Chronic lung disease
Dementia or other neurological conditions
Disabilities (e.g., Down syndrome, spinal cord injuries)
Diabetes
Cardiovascular disease
Immunosuppressive disease or treatment
Body mass index (BMI) > 25 kg/m2 in adults and physical inactivity
Pregnancy
Sickle cell disease or thalassemia
Stroke or cerebrovascular disease
Current or former smoking
Mental health conditions (e.g., depression, schizophrenia, substance use disorders)
Tuberculosis
Other medical conditions or factors (e.g., race or ethnicity) may also place patients at high risk

Patients under 18 years of age
Hospitalized due to COVID-19 (benefit not observed when initiated after hospitalization; patients admitted for other indications solely for infection control may be considered if all other requirements are met)
Use for longer than 5 consecutive days
Pre-exposure or post-exposure prophylaxis for prevention of COVID-19
Not approved for any use, including treatment of COVID-19 (EUA only)

Recommended dose: 800 mg (four 200 mg capsules) orally every 12 hours for 5 days
Can be taken with or without food
Missed dose within 10 hours of scheduled time: take as soon as possible and resume normal dosing; missed >10 hours: skip and restart normal regimen with next dose
Should be administered as soon as possible and within 5 days of symptom onset
No dose adjustment required for renal impairment, hepatic impairment, or geriatric patients
Patients requiring hospitalization after starting treatment may complete the full 5-day course at provider discretion

Review "Fact Sheet for Patients and Caregivers" with patient/caregiver prior to dispensing; document provision of electronic or hard copy
Inform patient/caregiver that MOV is an unapproved drug authorized under EUA
Inform that no adequate approved products exist for mild-moderate COVID-19 in high-risk patients
Inform that other currently authorized products exist for the same use
Discuss benefits and risks as outlined in the fact sheet
Assess pregnancy status in females of childbearing potential (clinically indicated)
Report all medication errors and serious adverse events potentially related to MOV within 7 calendar days via VA ADERS per local policy

Embryofetal toxicity noted in animal studies; not recommended during pregnancy unless benefits outweigh risks
Females of childbearing potential: use reliable contraception correctly and consistently during treatment and for 4 days after the last dose
Males of reproductive potential sexually active with females of childbearing potential: use reliable contraception during treatment and for at least 3 months after the last dose
Pregnancy status does not need confirmation if surgically sterilized, using an IUD/implant, or pregnancy is impossible
If prescribed during pregnancy: document discussion of benefits/risks, inform about Merck pregnancy surveillance program, obtain consent to share patient information with Merck (provide name and contact)
Breastfeeding: not recommended during treatment and for 4 days after the final dose due to potential for adverse reactions in the infant

Monitor for hypersensitivity reactions, including anaphylaxis; immediately discontinue MOV and initiate supportive care if clinically significant reaction occurs
Monitor for bone and cartilage toxicity (not indicated <18 years)
Document and report all COVID-19 related adverse drug events to VA ADERS as a MedWatch report
VHA Center for Medication Safety conducts prospective pharmacovigilance; providers should monitor closely for unusual clinical or laboratory events.

At least one high-risk criteria for progression to severe disease as defined by the CDC
Alternative treatments authorized for mild-moderate COVID-19 in high-risk patients are not accessible or clinically appropriate

Females of childbearing potential and males sexually active with females of childbearing potential must agree to use a reliable method of contraception correctly and consistently during treatment and for 4 days (females) or 3 months (males) after the last dose
Pregnancy status must be determined to be negative for females of childbearing potential (unless surgically sterilized, has an intrauterine device/contraceptive implant, or is unable to get pregnant)
For pregnant patients: Provider must communicate known and potential risks of MOV during pregnancy and document; inform patient of the Merck pregnancy surveillance program; provide patient’s name to Merck if patient agrees to participate and allows disclosure

800mg orally q12h for 5 days (with or without food)
No dose adjustments recommended for renal or hepatic impairment or in geriatric patients

Provider must review the “Fact Sheet for Patients and Caregivers” with the patient/caregiver prior to administration and provide an electronic or hard copy
Report all medication errors and serious adverse drug events possibly related to MOV through the VA ADERS program
In-line patient request form required prior to initiation capturing: patient name, last 4 of SSN, DOB, date of positive test, confirmation of mild/moderate diagnosis, timing within 5 days, high-risk status per CDC, inaccessibility/appropriateness of alternatives, fact sheet provision, and pregnancy/contraception status
Post-dispensing tracking required: date dispensed, order number, number/dose dispensed, lot numbers, adverse events documentation, and certification of accuracy/completeness