What is XOCOVA?
XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12.
Important Safety Information and Use
Do not take XOCOVA if you:
- are allergic to ensitrelvir or any of the ingredients in XOCOVA.
-
take any of the following medicines, as these 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. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines.
Before taking XOCOVA, tell your HCP about all your medical conditions, including if you:
-
are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use.
-
are breastfeeding or plan to breastfeed.
It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP.
What are the possible side effects of XOCOVA?
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 allergic reaction symptoms: 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; or vomiting.
The most common side effects of XOCOVA include: headache,
diarrhea, and cough.
These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information,
including Patient Information, for XOCOVA.
