Elbasvir/grazoprevir - oral
Elbasvir/grazoprevir - oral
Although this product helps many people with hepatitis C, it may rarely cause serious liver problems. Also, people who have another liver problem called hepatitis B may get worse. Before starting this product, tell your doctor if you have ever had hepatitis B. Tell your doctor right away if you have new or worsening symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, dark urine or yellowing eyes/skin.
This medication is used to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Elbasvir and grazoprevir work by reducing the amount of hepatitis C virus in your body, which helps your immune system fight the infection and may help your liver recover. This product may also be used with certain other medications (such as ribavirin). Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis) or liver cancer.
It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Remove one dose from the original package just before taking. Take this medication by mouth with or without food as directed by your doctor, usually once a day.
This product works best when the amount of drug in your body is kept at a constant level. Take this product at evenly spaced intervals. To help you remember, take it at the same time each day.
Continue to take this product for the full length of time prescribed, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.
See also Warning section.
Tiredness, headache, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this product because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this product do not have serious side effects.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this product, tell your doctor or pharmacist if you are allergic to elbasvir or grazoprevir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this product, tell your doctor or pharmacist your medical history, especially of:
If you have diabetes, your blood sugar may be lower with hepatitis C treatment. This can increase your risk of low blood sugar, so your doctor may adjust your diabetes treatment plan. Tell your doctor right away if you have symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet.
Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.
If this product is used in combination with ribavirin, it must not be used during pregnancy by either the pregnant woman or her male partner. Ribavirin may harm an unborn baby. Two reliable forms of birth control (such as condoms, birth control pills) must be used whenever at least one sexual partner is using these medicines together, and for 6 months after stopping treatment. If you or your partner becomes pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.
It is unknown if the medications in this product pass into breast milk. Breast-feeding while using this product with ribavirin is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bosentan, cyclosporine, efavirenz, etravirine, modafinil, nafcillin, HIV protease inhibitors (such as atazanavir, saquinavir), rifamycins (such as rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), St. John's wort, among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this product with others.
Lab tests (such as liver function, tests for hepatitis B and C) should be done before you start using this medication, while you are using it, and after completing treatment. Keep all medical and lab appointments.
If you are using this product with ribavirin, it is recommended that female patients or female partners of male patients take a pregnancy test before starting treatment. A pregnancy test should also be taken every month while using this product and for 6 months after treatment ends to make sure no pregnancy occurs.
If you miss a dose, take it as soon as you remember. If it is 8 hours or less until the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store in the original package at room temperature away from light and moisture. Moisture will affect this medication, so do not take the tablets out of the original package to store in another container, such as a pill box. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised January 2019.
Copyright(c) 2019 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.