PAXLOVID (EUA)

NIRMATRELVIR; RITONAVIR (NIR ma TREL vir; ri TOE na veer) treats mild to moderate COVID-19. It may help people who are at high risk of developing severe illness. This medication works by limiting the spread of the virus in your body. The FDA has allowed the emergency use of this medication.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

This product contains 2 different medications that are packaged together. For the standard dose, take 2 pink tablets of nirmatrelvir with 1 white tablet of ritonavir (3 tablets total) by mouth with water twice daily. Talk to your care team if you have kidney disease. You may need a different dose. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.
Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medication with any of the following medications:
-Alfuzosin
-Certain medications for anxiety or sleep like midazolam, triazolam
-Certain medications for cancer like apalutamide, enzalutamide
-Certain medications for cholesterol like lovastatin, simvastatin
-Certain medications for irregular heart beat like amiodarone, dronedarone, flecainide, propafenone, quinidine
-Certain medications for pain like meperidine, piroxicam
-Certain medications for psychotic disorders like clozapine, lurasidone, pimozide
-Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
-Colchicine
-Eletriptan
-Eplerenone
-Ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
-Finerenone
-Flibanserin
-Ivabradine
-Lomitapide
-Naloxegol
-Ranolazine
-Rifampin
-Sildenafil
-Silodosin
-St. John's Wort
-Tolvaptan
-Ubrogepant
-Voclosporin
This medication may also interact with the following medications:
-Bedaquiline
-Birth control pills
-Bosentan
-Certain antibiotics like erythromycin or clarithromycin
-Certain medications for blood pressure like amlodipine, diltiazem, felodipine, nicardipine, nifedipine
-Certain medications for cancer like abemaciclib, ceritinib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine
-Certain medications for cholesterol like atorvastatin, rosuvastatin
-Certain medications for depression like bupropion, trazodone
-Certain medications for fungal infections like isavuconazonium, itraconazole, ketoconazole, voriconazole
-Certain medications for hepatitis C like elbasvir; grazoprevir, dasabuvir; ombitasvir; paritaprevir; ritonavir, glecaprevir; pibrentasvir, sofosbuvir; velpatasvir; voxilaprevir
-Certain medications for HIV or AIDS
-Certain medications for irregular heartbeat like lidocaine
-Certain medications that treat or prevent blood clots like rivaroxaban, warfarin
-Digoxin
-Fentanyl
-Medications that lower your chance of fighting infection like cyclosporine, sirolimus, tacrolimus
-Methadone
-Quetiapine
-Rifabutin
-Salmeterol
-Steroid medications like betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Your condition will be monitored carefully while you are receiving this medication. Visit your care team for regular checkups. Tell your care team if your symptoms do not start to get better or if they get worse.
If you have untreated HIV infection, this medication may lead to some HIV medications not working as well in the future.
Birth control may not work properly while you are taking this medication. Talk to your care team about using an extra method of birth control.

If you miss a dose, take it as soon as you can unless it is more than 8 hours late. If it is more than 8 hours late, skip the missed dose. Take the next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

Side effects that you should report to your care team as soon as possible:
-Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
-Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
-Redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Change in taste
-Diarrhea
-General discomfort and fatigue
-Increase in blood pressure
-Muscle pain
-Nausea
-Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children and pets.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.
To get rid of medications that are no longer needed or have expired:
-Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
-If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.