What is the most important information I should know about elbasvir and grazoprevir?
You should not use this medicine if you have moderate or severe liver disease.
Serious drug interactions can occur when certain medicines are used together. Tell your doctor about all your current medicines and any you start or stop using.
If you have ever had hepatitis B, elbasvir and grazoprevir can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function.
What is elbasvir and grazoprevir?
Elbasvir and grazoprevir are antiviral medicines that prevent hepatitis C (HCV) from multiplying in your body.
Elbasvir and grazoprevir is a combination medicine used to treat chronic hepatitis C in adults. This medicine is sometimes given together with another drug called ribavirin.
Elbasvir and grazoprevir treats specific genotypes of hepatitis C, and only in certain people. Use only the medications prescribed for you. Do not share your medicine with other people.
Elbasvir and grazoprevir is sometimes used in people who also have HIV. This medicine is not a treatment for HIV or AIDS.
Elbasvir and grazoprevir may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking elbasvir and grazoprevir?
You should not use this medicine if you are allergic to elbasvir or grazoprevir, or if you have:
- moderate or severe liver disease.
If you take elbasvir and grazoprevir with ribavirin: There may be other reasons you should not take this combination treatment. Tell your doctor about all your medical conditions.
Some medicines can cause unwanted or dangerous effects when used with elbasvir and grazoprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:
- cyclosporine;
- rifampin;
- St. John's wort;
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HIV or AIDS medication --atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or
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seizure medicine --carbamazepine, phenytoin.
To make sure elbasvir and grazoprevir is safe for you, tell your doctor if you have ever had:
- hepatitis B;
- liver problems other than hepatitis C;
- HIV (human immunodeficiency virus);
- if you have had a liver transplant, or if you are waiting to have a liver transplant; or
- if you use a blood thinner (warfarin, Coumadin, Jantoven) and you have routine "INR" or prothrombin time tests.
It is not known whether elbasvir and grazoprevir will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Elbasvir and grazoprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby.
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If you are a woman, do not use ribavirin if you are pregnant. You may need to have a negative pregnancy test before taking ribavirin and every month during your treatment.
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If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could be harmed if you have sex with a pregnant woman while you are taking ribavirin.
While taking elbasvir and grazoprevir with ribavirin, use at least 2 effective forms of birth control to prevent pregnancy, whether you are a man or a woman. Ribavirin use by either parent may cause birth defects.
Keep using 2 forms of birth control for at least 6 months after your last dose of ribavirin. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.
It is not known whether elbasvir and grazoprevir passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Elbasvir and grazoprevir is not approved for use by anyone younger than 18 years old.
How should I take elbasvir and grazoprevir?
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using elbasvir and grazoprevir.
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You may take elbasvir and grazoprevir with or without food.
Take the medicine at the same time each day.
You will need frequent blood tests to check your liver function.
If you have ever had hepatitis B, elbasvir and grazoprevir can cause this condition to come back or get worse. You will need liver function tests during treatment and for several months after you stop using this medicine.
Hepatitis C is often treated with a combination of drugs. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.
You should not stop using elbasvir and grazoprevir suddenly. Stopping suddenly could make your hepatitis C harder to treat with antiviral medicine.
Store at room temperature away from moisture and heat. Keep each tablet in the foil blister pack until you are ready to take it.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking elbasvir and grazoprevir?
Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
What are the possible side effects of elbasvir and grazoprevir?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have new or worsening symptoms such as:
- nausea, vomiting, upper stomach pain, loss of appetite;
- tiredness;
- dark urine, clay-colored stools;
- jaundice (yellowing of the skin or eyes); or
- (if you also take ribavirin) low red blood cells (anemia) --pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
- headache;
- anemia;
- depression, feeling tired or irritable;
- shortness of breath;
- itching or rash;
- sleep problems (insomnia); or
- joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect elbasvir and grazoprevir?
When you start or stop taking elbasvir and grazoprevir, your doctor may need to adjust the doses of any other medicines you take on a regular basis.
Many drugs can interact with elbasvir and grazoprevir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with daclatasvir. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about elbasvir and grazoprevir.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 2.01. Revision date: 12/26/2017.
