boceprevir

Generic Name: boceprevir (boe SEP re vir)
Brand Name: Victrelis

What is boceprevir?

Boceprevir is an antiviral medication that prevents certain virus cells from multiplying in your body.

Boceprevir is used in combination with peginterferon alfa and ribavirin to treat hepatitis C in adults.

Boceprevir may also be used for purposes not listed in this medication guide.

What is the most important information I should know about boceprevir?

Boceprevir must be used in combination with peginterferon alfa and ribavirin.

Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant.

Slideshow: Sovaldi and The Evolving Course of Hepatitis C Therapy

Certain other drugs may interact with boceprevir or should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

What should I discuss with my healthcare provider before taking boceprevir?

You should not use boceprevir if you are allergic to it.

Do not take boceprevir as your only hepatitis medicine. Boceprevir must be used in combination with peginterferon alfa and ribavirin. Read the medication guide or patient instructions provided with each medicine you take. In some cases, you may not be able to use this drug combination.

To make sure you can safely take boceprevir, tell your doctor if you have:

  • liver problems other than hepatitis C (including hepatitis B);

  • a history of liver or other organ transplant; or

  • low white blood cell (WBC) or red blood cell (RBC) counts, or low levels of platelets in in your blood;

Some medicines can cause unwanted or dangerous effects when used with boceprevir. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • cisapride;

  • drospirenone (Yasmin, Yaz, Angeliq, and others);

  • pimozide;

  • rifampin;

  • St. John's wort;

  • alfuzosin, doxazosin, silodosin, tamsulosin;

  • lovastatin or simvastatin;

  • oral midazolam or triazolam;

  • ergonovine, ergotamine, dihydroergotamine, methylergonovine;

  • the seizure medications carbamazepine, phenobarbital, or phenytoin; or

  • sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension.

FDA pregnancy category X. Boceprevir is given together with interferon alfa and ribavirin. Although boceprevir is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.

  • Use at least 2 non-hormonal forms of birth control while either sexual partner is using boceprevir with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

  • If you are a woman, do not use boceprevir with interferon alfa and ribavirin if you are pregnant.

  • If you are a man, do not use boceprevir with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

  • Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking boceprevir.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using boceprevir with interferon alfa and ribavirin.

It is not known whether boceprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using boceprevir.

How should I take boceprevir?

Boceprevir is used in combination with peginterferon alfa and ribavirin. Follow all directions on your prescription label. Your doctor may occasionally change your doses to make sure you get the best results. Do not take these medicines in larger or smaller amounts or for longer than recommended.

Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

Take boceprevir with food. The usual dose of boceprevir is 4 capsules taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.

Your total daily dose of 12 capsules is contained in a single bottle of boceprevir. A carton of boceprevir contains 28 bottles for a 4-week supply.

To be sure this medicine is helping your condition, you will need frequent blood tests. Treatment with boceprevir may be discontinued based on the results of these tests.

Store boceprevir capsules in the refrigerator, do not freeze. Throw away any unused capsules after the expiration date on the label has passed.

You may also store the capsules at room temperature for up to 3 months. Protect the capsules from heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. 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 boceprevir?

Taking this medicine 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 transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Boceprevir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using boceprevir and call your doctor at once if you have:

  • tired feeling, weakness, confusion;

  • easy bruising or bleeding (nosebleed, bleeding gums);

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Common side effects may include:

  • headache;

  • altered sense of taste; or

  • nausea.

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.

See also: Side effects (in more detail)

Boceprevir dosing information

Usual Adult Dose for Chronic Hepatitis C:

800 mg orally 3 times a day (7 to 9 hours apart) with food

DURATION OF THERAPY:
In Patients without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy (HCV-RNA levels should be monitored at treatment weeks [TWs] 8, 12, and 24 to determine duration of therapy and assess for treatment futility):
Previously untreated patients:
-HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen (boceprevir, peginterferon alfa, ribavirin) at TW 28.
-HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.
-Poorly interferon responsive at TW 4: Consider using 3-drug regimen for 44 weeks (to maximize rates of sustained virologic response [SVR]).

Previous partial responders or relapsers:
-HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen at TW 36.
-HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.

Previous null responders:
-HCV-RNA detected or not detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 48.

In Patients with Compensated Cirrhosis:
-The 3-drug regimen should be used for 44 weeks.

TREATMENT FUTILITY:
-Therapy discontinuation is recommended in all patients with (a) HCV-RNA levels at least 1000 international units/mL at TW 8, or (b) HCV-RNA levels at least 100 international units/mL at TW 12, or (c) confirmed detectable HCV-RNA levels at TW 24.

COMMENTS:
-Therapy should be initiated with peginterferon alfa and ribavirin for 4 weeks; boceprevir should be added to the regimen after the initial 4 weeks of therapy.
-Duration of therapy is based on viral response, prior response status, and presence of cirrhosis.
-Poorly interferon responsive patients using this regimen are less likely to achieve SVR, and have a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
-The risks/benefits of this regimen should be carefully considered before starting therapy in patients with compensated cirrhosis who have platelet count less than 100,000/mm3 and serum albumin less than 3.5 g/dL at baseline.

USE: For the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers

What other drugs will affect boceprevir?

Many drugs can interact with boceprevir. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with boceprevir, especially:

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • hormone replacement therapy, birth control pills, implants, vaginal rings, or injections;

  • sildenafil (Viagra) and other erectile dysfunction medicines;

  • an antibiotic or antifungal medicine--clarithromycin, itraconazole, ketoconazole, posaconazole, rifabutin, voriconazole; asthma or allergy medicine--budesonide, fluticasone, salmeterol (Advair, Serevent); steroid medicine--dexamethasone, prednisone, prednisolone;

  • an antidepressant--desipramine, escitalopram; narcotic medication--buprenorphine, methadone, naloxone; a sedative--alprazolam, trazodone;

  • cholesterol-lowering drugs--atorvastatin, pravastatin; heart or blood pressure medicine--amlodipine, amiodarone, digoxin, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, propafenone, quinidine, verapamil; or

  • HIV or AIDS medicines--atazanavir, darunavir, efavirenz, etravirine, lopinavir, raltegravir, ritonavir; medicine to prevent organ transplant rejection--cyclosporine, sirolimus, tacrolimus.

This list is not complete and many other drugs can interact with boceprevir. 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 boceprevir.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2014-03-16, 10:59:51 PM.

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