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 genotype 1 or 4 in adults. This medicine is sometimes given together with another drug called ribavirin (Copegus, Rebetol, Moderiba, Ribasphere).
Elbasvir and grazoprevir is used only if your HCV has a specific genetic marker, for which your doctor will test.
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.
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;
- HIV or AIDS medication--atazanavir, darunavir, efavirenz, lopinavir, saquinavir, tipranavir; or
- seizure medicine--carbamazepine, phenytoin.
To make sure elbasvir and grazoprevir is safe for you, tell your doctor if you have:
- a history of hepatitis B;
- liver problems other than hepatitis, or if you have had a liver transplant;
- HIV (human immunodeficiency virus); or
- if you are waiting to have a liver transplant.
It is not known whether this medicine will harm an unborn baby. Elbasvir and grazoprevir is sometimes used in combination with ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. You may need to have a negative pregnancy test before using these medications together, and every month during your treatment.
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If you are a woman, do not use elbasvir and grazoprevir with ribavirin if you are pregnant.
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If you are a man, do not use this drug combination if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
- Use at least 2 effective forms of non-hormonal birth control (condom, diaphragm with spermicide) while either sexual partner is using these medications together. Keep using 2 forms of birth control for at least 6 months after treatment ends. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using elbasvir and grazoprevir with 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.
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 this medicine suddenly. Stopping suddenly could make your condition harder to treat with hepatitis C antiviral medicine.
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.
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?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
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:
- 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) pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.
Common side effects may include:
- headache;
- nausea, diarrhea;
- sleep problems (insomnia); or
- feeling tired.
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?
Many drugs can interact with elbasvir and grazoprevir. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- bosentan;
- modafinil;
- tacrolimus;
- antibiotic or antifungal medicine;
- antiviral medicine to treat hepatitis or HIV/AIDS;
- cholesterol medication;
- heart or blood pressure medicine; or
- tuberculosis medicine.
This list is not complete and many other drugs can interact with elbasvir and grazoprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. 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.
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