Glecaprevir (glek-A-pre-vir), Pibrentasvir (pi-BRENT-as-vir)

Treats chronic hepatitis C infection.

Brand Name(s):

Mavyret

When This Medicine Should Not Be Used:

How to Use This Medicine:

Pellet, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• It is best to take this medicine with food or milk.
• Oral pellets:
  • Mix the medicine on a small amount of soft food (including peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt) with little amount of water that will stick to a spoon and should be swallowed without chewing.
  • Swallow the mixture within 15 minutes after preparation. Do not crush or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • If you miss a dose and it is less than 18 hours from your usual time, take the missed dose as soon as possible, and then go back to your regular schedule.
  • If you miss a dose and it is more than 18 hours from your usual time, skip the missed dose and take your next dose at your regular schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep this medicine in its original container until you are ready to use it. Throw away any unused medicine. Do not store and reuse any leftover mixture.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with atazanavir or rifampin.
• Some medicines can affect how glecaprevir/pibrentasvir works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cyclosporine, dabigatran, digoxin, phenytoin, St John's wort
  • Birth control pills (containing ethinyl estradiol)
  • Medicine to lower cholesterol (including atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin)
  • Medicine to treat HIV infection (including darunavir, efavirenz, lopinavir, ritonavir)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease or other liver disease (including hepatitis B). Tell your doctor if you are having a kidney or liver transplant.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark urine, pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088