Lagevrio

LAGEVRIO is an investigational medicinal product used to treat mild to moderate COVID-19 in adults:

• with positive results of direct testing for SARS-CoV-2 virus, and
• who are at high risk of progression to severe COVID-19, including hospitalization or death, and for whom other FDA-approved or cleared COVID-19 treatment options are not available or clinically appropriate.

The FDA has approved the emergency use of LAGEVRIO for the treatment of mild to moderate COVID-19 in adults under the EUA.

LAGEVRIO is not approved:

• for use in persons under 18 years of age.
• for the prevention of COVID-19.
• for persons requiring hospitalization due to COVID-19.
• for use for more than 5 consecutive days.

Each LAGEVRIO oral capsule contains 200 mg of molnupiravir and the following excipients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and purified water. The capsule shell contains hypromellose, iron oxide red and titanium dioxide. The capsule is printed with white ink containing butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution and titanium dioxide.

• Take LAGEVRIO only as recommended by your healthcare provider.
• Take 4 capsules of LAGEVRIO every 12 hours (e.g., at 8 a.m. and 8 p.m.)
• Take LAGEVRIO for 5 days. It is important that you complete the full 5 days of treatment with LAGEVRIO. Do not stop taking LAGEVRIO before you have completed the full 5 days of treatment, even if you feel better.
• Take LAGEVRIO with or without food.
• You should stay in isolation for as long as your healthcare provider tells you to. Talk to your healthcare provider if you are not sure how to properly stay in isolation during COVID-19.
• LAGEVRIO capsules should be swallowed whole. Do not open, break, or crush the capsules. If you are unable to swallow the capsules whole, tell your healthcare provider.
• What to do if you miss a dose:
  • If it has been less than 10 hours since you missed a dose, take it as soon as you remember
  • If more than 10 hours have passed since the missed dose, do not take the missed dose and take the dose at the next scheduled time.
• Do not double the dose of LAGEVRIO to make up for a missed dose.

People who take LAGEVRIO may have allergic reactions even after taking 1 dose. Stop taking LAGEVRIO and contact your healthcare provider right away if you experience any of the following symptoms of an allergic reaction:

• urticaria
• rapid heartbeat
• difficulty swallowing or breathing
• swelling of the mouth, lips or face
• a feeling of tightness in the throat
• hoarseness
• rash on the skin

The most common adverse reactions when using LAGEVRIO:

• diarrhea
• nausea
• dizziness

LAGEVRIO is not recommended for use during pregnancy and in minors.

Capsules of 200 mg. Opaque capsules, size 0, orange color (Swedish Orange). The capsules contain the corporate logo and “82” printed in white ink.

Store LAGEVRIO capsules at room temperature between 68°F and 77°F (20°C and 25°C). Keep LAGEVRIO and all medicines out of the reach of children and pets.

Produced for: Merck Sharp & Dow LLP. Rahway, New Jersey 07065, USA