Elbasvir; Grazoprevir Tablets

What is this medication?

ELBASVIR; GRAZOPREVIR (EL bas vir; graz OH pre vir) treats infections caused by the hepatitis C virus. It works by limiting the spread of the virus inside the body. It will not treat colds, the flu, or infections caused by bacteria.

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

COMMON BRAND NAME(S): ZEPATIER

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Have ever taken any medication for hepatitis C
• History of hepatitis B infection
• History of or waiting for a liver transplant
• HIV or AIDS
• Other liver disease
• An unusual or allergic reaction to elbasvir, grazoprevir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Keep taking this therapy unless your care team tells you to stop.

Talk to your care team about the use of this medication in children. While it may be prescribed for children 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.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain antiviral medications for HIV or AIDS, such as atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir
• Certain medications for seizures, such as carbamazepine, phenytoin
• Cyclosporine
• Enasidenib
• Rifampin
• St. John's wort
• Trofinetide

This medication may also interact with the following:

• Bosentan
• Certain antiviral medications for HIV or AIDS, such as cobicistat, elvitegravir, emtricitabine, tenofovir, etravirine
• Certain medications for cholesterol, such as atorvastatin, fluvastatin, lovastatin, rosuvastatin, simvastatin
• Certain medications for diabetes
• Ketoconazole
• Modafinil
• Nafcillin
• Tacrolimus
• Warfarin

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.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team. You will need to have important blood work done while taking this medication.

This medication may increase blood sugar. The risk may be higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

What side effects may I notice from receiving this medication?

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

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Headache
• Nausea
• Trouble sleeping

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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 to 25 degrees C (68 to 77 degrees F). Keep this medication in the original packaging until you are ready to take it. Protect from moisture. 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.