Xocova

Xocova is used to prevent COVID-19 from developing after contact with a person who has COVID-19 (post-exposure prophylaxis). Xocova is taken once a day, starting as soon as possible and within 72 hours of COVID-19 exposure.

• It is not known if Xocova is safe and effective in children less than 12 years of age.

Xocova (ensitrelvir) works by inhibiting an enzyme called SARS-CoV-2 main protease (Mpro), which the COVID-19 virus relies upon for viral replication. Xocova renders Mpro incapable of processing viral proteins, preventing it from making copies of itself. Xocova belongs to the drug class called SARS-CoV-2 Mpro inhibitors.

Xocova (ensitrelvir) received FDA approval on June 1, 2026. Xocova is the first oral medication proven to prevent symptomatic COVID-19 after exposure. In the Phase 3 SCORPIO-PEP clinical trial, it reduced symptomatic COVID-19 risk by 67% compared to placebo. Xocova was well tolerated, with side effect rates similar to placebo.

• Take Xocova exactly as your healthcare provider tells you to take it.
• Take Xocova for 5 days. Do not stop taking Xocova without talking to your healthcare provider.
• Xocova comes in a blister pack containing 7 tablets.
• Do not remove Xocova tablets from the blister pack until you are ready to take your dose.
• Take Xocova with or without food.
• Take Xocova at about the same time each day.
• If you miss a dose of Xocova, take the missed dose as soon as possible on that same day. Then return to the normal dosing schedule the next day.
• If you take too much Xocova, call your healthcare provider or go to the nearest hospital emergency room right away.

Do not take Xocova if you:

• are allergic to ensitrelvir or any of the ingredients in Xocova. See the end of this leaflet for a complete list of ingredients in Xocova. See also Serious side effects of Xocova, for signs and symptoms of allergic reactions.
• Take any of the following medicines, as these medicines may interact with Xocova and may cause severe or life-threatening side effects or death: apalutamide carbamazepine colchicine dihydroergotamine enzalutamide eplerenone ergotamine finerenone ivabradine lomitapide lumacaftor/ivacaftor lurasidone methylergonovine phenytoin pimozide quinidine rifampin St. John’s wort simvastatin triazolam voclosporin.
• These are not the only medicines that may cause serious or life-threatening side effects if taken with Xocova.
• Xocova may increase or decrease the levels of many medicines in your body.
• It is very important to tell your healthcare provider about all of the medicines you take because additional laboratory tests or changes in the dose of your other medicines may be necessary during treatment with Xocova.
• Your healthcare provider may tell you about specific symptoms to watch for that may indicate that you need to stop or decrease the dose of some of your other medicines.

Before taking Xocova, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Xocova may harm your unborn baby. Females who can become pregnant:

• Your healthcare provider will check with you to see if you are pregnant before you start Xocova.
• Use effective birth control (contraception) during treatment with Xocova and for 2 weeks after the final dose of Xocova.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Xocova.

Breastfeeding

It is not known if Xocova passes into your breastmilk. Do not breastfeed during treatment with Xocova and for 2 weeks after the final dose of Xocova.

Common Side Effects

The most common side effects of Xocova are:

• Headache
• Diarrhea
• Cough.

Serious Side Effects

Xocova may cause serious side effects, including:

• Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking Xocova and get medical help right away if you get any of the following symptoms of an allergic reaction: skin rash, hives itching swelling of the mouth, lips, tongue, or face trouble swallowing or breathing throat tightness dizziness or feeling lightheaded stomach-area (abdomen) pain vomiting.

These are not all of the possible side effects of Xocova. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Dose of Xocova 125 mg for COVID-19 Prevention (Adults and Children 12+)

• Day 1: Take 3 tablets together as a single dose.
• Days 2 through 5: Take 1 tablet once daily.

The full course is 7 tablets taken over 5 days. Try to take each dose at about the same time each day.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. See “Do not take Xocova if you:” for a list of medicines that interact with Xocova.

You should not take Xocova with:

• Drugs broken down by the CYP3A enzyme, where higher blood levels could cause serious or life-threatening effects. Examples include some statins (simvastatin), certain sedatives (midazolam, triazolam), and some immunosuppressants (cyclosporine, tacrolimus).
• Strong CYP3A inducers that can lower Xocova levels in the blood, potentially making it less effective. Examples include rifampin, carbamazepine, phenytoin, and St. John's Wort.

Your healthcare provider can tell you if it is safe to take Xocova with other medicines.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with Xocova.

Do not start taking a new medicine without telling your healthcare provider.

• Store Xocova at room temperature between 68°F and 77°F (20°C and 25°C).
• Store Xocova in the original package.

Keep Xocova and all medicines out of the reach of children.

Active ingredient: ensitrelvir

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and magnesium stearate.

Xocova is manufactured for Shionogi Inc., Florham Park, NJ 07932.