Boceprevir oral capsules

What is this medicine?

BOCEPREVIR (boe SE pre vir) is an antiviral medicine. It is used with peginterferon alfa and ribavirin to treat hepatitis C. It will not work for colds, flu, or other viral infections.

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dizziness

• rash, fever, and swollen lymph nodes

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste

• diarrhea

• irritability

• nausea, vomiting

• unusually weak or tired

What may interact with this medicine?

Do not take this medicine with the following medication:

• alfuzosin

• carbamazepine

• cisapride

• doxazosin

• drospirenone

• ergot derivatives

• lovastatin

• lumacaftor; ivacaftor

• lurasidone

• midazolam

• phenobarbital

• phenytoin

• pimozide

• rifampin

• sildenafil

• silodosin

• simvastatin

• St. John's wort (Hypericum perforatum)

• tadalafil

• tamsulosin

• triazolam

This medicine may also interact with the following medications:

• amiodarone

• atorvastatin

• bepridil

• bosentan

• budesonide

• buprenorphine

• calcium channel blockers like amlodipine, diltiazem, felodipine, nifedipine, nicardipine, nisoldipine, and verapamil

• clarithromycin

• colchicine

• cyclosporine

• desipramine

• dexamethasone

• digoxin

• efavirenz

• ethinyl estradiol

• flecainide

• fluticasone

• itraconazole

• ketoconazole

• methadone

• posaconazole

• propafenone

• quinidine

• rifabutin

• ritonavir

• salmeterol

• sirolimus

• tacrolimus

• trazodone

• vardenafil

• voriconazole

• warfarin

What if I miss a dose?

If you miss a dose and remember the same day, take it as soon as you remember. If the whole day has passed, ask your health care provider what to do. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 2 and 8 degrees C (36 and 46 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• HIV or AIDS

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• low blood counts, like low white cell, platelet, or red cell counts

• man with a partner who is pregnant or trying to get pregnant

• organ transplant

• other liver disease

• an unusual or allergic reaction to boceprevir, ribavirin, interferons, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

See your doctor or healthcare provider for a follow-up visit as directed. You may need blood work while you are taking this medicine. Tell your doctor if your symptoms do not improve or if they get worse.

This medicine must be given with ribavirin. Ribavirin may cause birth defects or death to an unborn child. Women taking this medicine must avoid pregnancy while taking this medicine and for 6 months after stopping this medicine. Men who are taking this medicine must avoid getting a woman pregnant while taking this medicine and for 6 months after stopping this medicine. Use 2 forms of birth control. Women who can still have children must have a negative pregnancy test before starting treatment. Take monthly pregnancy tests while you are taking this medicine and for 6 months after this medicine is stopped. Talk to your doctor if you think that you or your partner are pregnant or are trying to become pregnant.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.