Mavyret

Mavyret is a prescription medication that is used to treat certain types of chronic (long-term) hepatitis C infection (inflammation of the liver caused by a virus) in adults. 

Mavyret is a single product containing 2 medications: glecaprevir and pibrentasvir. Glecaprevir belongs to a group of drugs called HCV NS3/4A protease inhibitors. They work by decreasing the amount of HCV in the body. Pibrentasvir belongs to a class of medications called HCV NS5A inhibitors. They work by stopping the virus that causes hepatitis C from spreading inside the body.

Mavyret comes in a tablet form and is typically taken once daily with food.

Common side effects of Mavyret include headache and tiredness. Since Mavyret can cause tiredness, do not drive or operate heavy machinery until you know how Mavyret affects you.

Mavyret is a prescription medication that is used to treat certain types of chronic (long-term) hepatitis C infection without cirrhosis (scarring of the liver) or with compensated cirrhosis (chronic liver disease without symptoms).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mavyret. See the “Mavyret Precautions” section.

Common side effects of Mavyret include the following:

• headache 
• extreme tiredness

This is not a complete list of Mavyret side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• P-glycoprotein substrates
  • medications that use the p-glycoprotein transporter such as digoxin (Lanoxin), loperamide (Imodium), quinidine (Cardioquine, Quinact, Duraquin), vinblastine (Velban), fexofenadine (Allegra), indinavir (Crixivan), colchicine (Colcrys), topotecan (Hycamtin), and paclitaxel (Abraxane, Onxol, Taxol)
• BCRP substrates
  • medications that use the enzyme called BCRP such as methotrexate, topotecan, irinotecan
• OATP1B1 or OATP1B3 substrates: medications that get transported from the bloodstream into cells by OATP molecules to get metabolized, such as 
  • atorvastatin (Lipitor) 
  • bilirubin 
  • digoxin (Lanoxin)
  • empagliflozin (Jardiance) 
  • ezetimibe (Zetia)
  • fexofenadine (Allegra) 
  • fluvastatin (Lescol) 
  • glyburide (DiaBeta)
  • lovastatin (Mevacor) 
  • methotrexate (Rheumatrex) 
  • olmesartan (Benicar) 
  • pitavastatin (Livalo) 
  • pravastatin (Pravachol)
  • repaglinide (Prandin) 
  • rifampin
  • Rosuvastatin (Crestor)
  • Simvastatin (Zocor) 
  • levothyroxine (Synthroid)
  • Telmisartan (Micardis)
  • Valsartan (Diovan)
• P-glycoprotein, BCRP, or OATP1B1/3 inhibitors
  • medications that block the p-glycoprotein transporter such as amiodarone (Cordarone, Pacerone), azithromycin (Zithromax, Zmax), captopril (Capoten), carvedilol (Coreg), clarithromycin (Biaxin), conivaptan (Vaprisol), cyclosporine (Neoral, Sandimmune, Gengraf), diltiazem (Cardizem), dronedarone (Multaq), erythromycin (EES, Ery-Tab), felodipine (Plendil),  itraconazole (Sporanox, Onmel), ketoconazole (Nizoral), lopinavir and ritonavir (Kaletra), quinidine (Cardioquine, Quinact, Duraquin), ranolazine (Ranexa), verapamil (Calan, Isoptin, Covera, Verelan)
  • medications that stop an enzyme called BCRP such as cyclosporine (Gengraf, Neoral, Sandimmune), eltrombopag (Promacta), gefitinib (Iressa)
  • medications that block OATP1B/3 transporters such as atazanavir (Reyataz), clarithromycin (Biaxin), cyclosporine (Neoral), erythromycin, gemfibrozil (Lopid), lopinavir/ritonavir (Kaletra), ritonavir/lopinavir (Kaletra), saquinavir (Invirase), simeprevir (Olysio), telithromycin (Ketek), tipranavir (Aptivus), rifampin, and velpatasvir (Epclusa)
• Strong CYP3A4 inducers
  • medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), efavirenz (Atripla), and St John's wort

This is not a complete list of Mavyret drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mavyret including the following:

• Hepatitis B virus reactivation (becoming active again). Before starting treatment with Mavyret, your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with Mavyret. Hepatitis B virus becoming active again may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking Mavyret.
• Risk of Mavyret not working as well due to use of Mavyret with carbamazepine, efavirenz containing regimens, or St. John’s wort at the same time. Mavyret may not be effective when taken together with these medications. See drug interactions section for more details.

Mavyret can cause tiredness. Do not drive or operate heavy machinery until you know how Mavyret affects you.

• Do not take Mavyret if you:
  • are allergic to Mavyret or to any of its ingredients
  • have certain liver problems
  • also take any of the following medicines:
    • atazanavir (Evotaz, Reyataz)
    • rifampin (Rifadin, Rifamate, Rifater, Rimactane)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Mavyret, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Mavyret, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Mavyret or to any of its ingredients
• have or have ever had hepatitis B virus infection
• have liver problems other than hepatitis C virus infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Mavyret. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. It is not known if Mavyret will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Mavyret crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Mavyret and the best way to feed your baby if you take Mavyret.

Take Mavyret exactly as prescribed.

Mavyret comes in a tablet form and is typically taken once daily with food.

Do not stop taking Mavyret without first talking with your healthcare provider. It is important that you do not miss or skip doses of Mavyret during treatment.

If you miss a dose of Mavyret and it is:

• Less than 18 hours from the time you usually take Mavyret, take the missed dose with food as soon as possible. Then take your next dose at your usual time.
• More than 18 hours from the time you usually take Mavyret, do not take the missed dose. Take your next dose as usual with food.
• Do not take two doses of Mavyret at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• if you have used previous medications to treat your hepatitis C
• whether or not you have cirrhosis (scarring) present in your liver

The recommended dose of Mavyret is 3 tablets (glecaprevir 300 mg and pibrentasvir 120 mg) taken by mouth once a day with food.

If you take too much Mavyret, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at or below 30°C (86°F).
• Keep Mavyret in its original blister package until you are ready to take it.
• Keep this and all medicines out of the reach of children.

Warning: risk of hepatitis B virus reactivation.

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, taking Mavyret may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or ever had a hepatitis B virus infection. Your doctor will order a blood test to see if you have or have ever had hepatitis B infection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If necessary, your doctor may give you medication to treat this infection before and during your treatment with Mavyret. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, pale (lighter colored) stools, stomach pain (right side of the belly below the ribs), or dark urine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before, during, and after your treatment to check your body's response to Mavyret.