Boceprevir is an antiviral used in combination with peginterferon and ribavirin to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Boceprevir is a protease inhibitor. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.
This combination reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safe sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
Do not use boceprevir alone to treat hepatitis C.
Read the Medication Guide provided by your pharmacist before you start taking boceprevir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food as directed by your doctor, usually three times daily (every 7 to 9 hours).
Boceprevir works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Continue to take boceprevir for the full length of time prescribed, even if your symptoms disappear after a short time. Stopping treatment too early may result in a return of chronic hepatitis C infection.
Vomiting, dry skin, or change in taste may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: unusual tiredness, pale skin, dizziness, fainting, rapid breathing, shortness of breath, fast heartbeat, signs of infection (such as fever, persistent sore throat, cough), easy bleeding/bruising.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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.
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 boceprevir, tell your doctor or pharmacist if you are allergic to it; 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 medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (such as anemia, low white blood cell count, low platelets), other liver problems.
Boceprevir can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, boceprevir should be used only when clearly needed. Boceprevir, in combination with peginterferon and ribavirin, must not be used during pregnancy by either the pregnant woman or her male partner. The combination may cause harm to 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 six months after stopping treatment (see also Drug Interactions section). If you or your partner become pregnant, or if you think you or your partner may be pregnant, tell your doctor right away.
It is unknown if this drug passes into breast milk. Breast-feeding while using boceprevir, in combination with peginterferon and 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 (including 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 boceprevir from your body, which may affect how boceprevir works. Examples include azole antifungals (such as ketoconazole, itraconazole), some anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), efavirenz, macrolide antibiotics (such as erythromycin), nevirapine, rifamycins (such as rifabutin, rifampin), St. John's wort, among others.
Boceprevir can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include some alpha blockers (such as alfuzosin, doxazosin, silodosin, tamsulosin), colchicine, drospirenone, lurasidone, pimozide, tacrolimus, ticagrelor, fluticasone, ergots (such as dihydroergotamine, ergotamine), drugs for irregular heartbeat (such as amiodarone, quinidine), HIV protease inhibitors (such as atazanavir, darunavir, lopinavir, ritonavir), some statins (such as lovastatin, simvastatin), sedatives (such as midazolam, triazolam), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), among others.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
If overdose is suspected, contact a poison control center or emergency room 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 medication with others.
Laboratory and/or medical tests (such as liver function tests, complete blood counts, hepatitis C virus RNA levels) must be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
It is recommended that female patients or female partners of male patients take a pregnancy test before starting this medication. A pregnancy test should also be taken every month while using this medication and for 6 months after treatment ends to make sure no pregnancy occurs.
If you miss a dose and it is more than 2 hours from the time you usually take the next dose, take it with food as soon as you remember. If it is less than 2 hours from the time you usually take the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store in the refrigerator. This medication may also be stored at room temperature, but only up to 3 months. Store away from light and moisture. 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.
Information last revised December 2014. Copyright(c) 2014 First Databank, Inc.
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