Boceprevir

Generic Name: boceprevir (boe-SE-pre-vir)
Brand Name: Victrelis

Boceprevir is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon alfa and ribavirin.

Boceprevir is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use boceprevir if:

  • you are allergic to any ingredient in boceprevir
  • you are taking alfuzosin, apixaban, avanafil, certain benzodiazepines (eg, oral midazolam, triazolam), cabazitaxel, cisapride, conivaptan, crizotinib, doxazosin, dronedarone, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HIV protease inhibitor and ritonavir combinations (eg, atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir), inhaled fluticasone, ivabradine, lovastatin, lurasidone, pimozide, rifampin, rivaroxaban, salmeterol, certain seizures medicines (eg, carbamazepine, phenobarbital, phenytoin), silodosin, simvastatin, St. John's wort, tamsulosin, ticagrelor, or tolvaptan
  • you take sildenafil or tadalafil for pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using boceprevir:

Some medical conditions may interact with boceprevir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have HIV infection or other immune system problems; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)
  • if you have other liver problems (eg, cirrhosis, hepatitis B infection)
  • if you have had an organ transplant
  • if you will be having surgery

Some MEDICINES MAY INTERACT with boceprevir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for anxiety, asthma or other lung or breathing problems, birth control, blood flow problems, blood thinning, cancer, Cushing syndrome, cystic fibrosis, diabetes, depression or other mental or mood problems, enlarged prostate, erectile dysfunction, gout, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, narcotic dependence, overactive bladder, PAH, pain, sleep, stomach or bowel problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with boceprevir

This may not be a complete list of all interactions that may occur. Ask your health care provider if boceprevir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use boceprevir:

Use boceprevir as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • Boceprevir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get boceprevir refilled.
  • Boceprevir must be taken with peginterferon alfa and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.
  • Take boceprevir by mouth with food (a meal or light snack).
  • Boceprevir is packaged into bottles that contain enough capsules for an entire day. Be sure you know how many capsules to take for each dose.
  • Boceprevir works best if it is taken at the same times each day.
  • Continue to take boceprevir even if you feel well. Do not miss any doses.
  • If you miss a dose of boceprevir, and it is more than 2 hours before your next dose, take the missed dose with food and go back to your regular dosing schedule. If you miss a dose of boceprevir, and it is less than 2 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use boceprevir.

Important safety information:

  • Boceprevir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use boceprevir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Boceprevir may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Boceprevir may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Boceprevir does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
  • Do not change your dose or stop taking boceprevir or any of your medicines without checking with your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking boceprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Women who may become pregnant and men who use boceprevir must use 2 effective forms of birth control while they take boceprevir with ribavirin and for at least 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using boceprevir. Talk with your doctor if you have questions about effective birth control.
  • Tell your doctor or dentist that you take boceprevir before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts and HCV levels, may be performed while you use boceprevir and for several months after you stop boceprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use boceprevir with caution in the ELDERLY; they may be more sensitive to its effects.
  • Boceprevir should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Boceprevir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using boceprevir. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using boceprevir while you are pregnant. It is not known if boceprevir is found in breast milk. Do not breast-feed while taking boceprevir.

Possible side effects of boceprevir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; decreased appetite; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; irritability; joint pain; nausea; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark, tarry, or bloody stools; fainting; fever, chills, or persistent sore throat; pale skin; severe or persistent dizziness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of boceprevir:

Store boceprevir in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Boceprevir may also be stored at room temperature up to 77 degrees F (25 degrees C) for 3 months. Keep boceprevir in the original container. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep boceprevir out of the reach of children and away from pets.

General information:

  • If you have any questions about boceprevir, please talk with your doctor, pharmacist, or other health care provider.
  • Boceprevir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take boceprevir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about boceprevir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to boceprevir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using boceprevir.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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