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

Do not take boceprevir as your only medication to treat hepatitis C. Boceprevir must be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab).

Read the medication guide or patient instructions provided with each medication in your combination therapy. 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.

Boceprevir is given together with interferon alfa and ribavirin. Ribavirin can 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. Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

The following drugs should not be used while you are taking boceprevir: alfuzosin (Uroxatral), cisapride (Propulsid), drospirenone (Angeliq, Beyaz, Safyral, Yasmin, Yaz), pimozide (Orap), lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin), midazolam (Versed), triazolam (Halcion), sildenafil or tadalafil when used to treat pulmonary arterial hypertension (Revatio, Adcirca), St. John's wort, rifampin (Rifadin, Rifater, Rifamate), ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), methylergonovine (Methergine), or the seizure medications carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin).

There are many other drugs that can interact with boceprevir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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 (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.

Read the medication guide or patient instructions provided with each medication in your combination therapy. 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.

Boceprevir is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.

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

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

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

To make sure you can safely take boceprevir, tell your doctor if you have hepatitis B or cirrhosis of the liver.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with boceprevir. The following drugs should not be used while you are taking boceprevir:

• alfuzosin (Uroxatral);
• cisapride (Propulsid);
• drospirenone (Angeliq, Beyaz, Safyral, Yasmin, Yaz);
• pimozide (Orap);
• lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin);
• midazolam (Versed) or triazolam (Halcion);
• sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;
• St. John's wort;
• the seizure medications carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin);
• rifampin (Rifadin, Rifater, Rifamate); or
• ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

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?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take boceprevir as your only medication to treat hepatitis C. Boceprevir must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant to boceprevir if you do not take it in combination with other medicines your doctor has prescribed.

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 and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

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?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of boceprevir?

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 a serious side effect such as:

• 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.

Less serious side effects may include:

• feeling weak, tired, or irritable;
• headache, dizziness;
• nausea, vomiting, loss of appetite;
• diarrhea;
• dry skin, hair loss;
• altered sense of taste;
• joint pain;
• sleep problems (insomnia); or
• mild skin rash.

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 boceprevir?

Tell your doctor about all other medicines you use, especially:

• an antibiotic;
• an antidepressant;
• an antifungal medication;
• anti-malaria drugs;
• anti-psychotic medication;
• asthma or allergy medication (including inhaled steroids);
• birth control or hormone replacement therapy that contains estrogen or progesterone;
• a blood thinner or medicine to prevent blood clots;
• cancer medicine;
• cholesterol-lowering drugs;
• cold or allergy medicine that contains an antihistamine;
• gout medication;
• heart or blood pressure medication;
• heart rhythm medication;
• HIV/AIDS medications;
• medicines used to prevent organ transplant rejection;
• narcotic medication;
• oral diabetes medication;
• a sedative (Valium, Xanax, BuSpar, and others);
• seizure medication; or
• stomach acid reducers (Prevacid, Zofran, and others).

This list is not complete and there are many other drugs that can interact with boceprevir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about boceprevir.