Boceprevir (By mouth)

Introduction

Boceprevir (boe-SE-pre-vir)

Used with peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®) to treat hepatitis C .

Brand Name(s)

Victrelis

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to boceprevir. Do not use this medicine if you are pregnant or breastfeeding, or if your female sexual partner is pregnant.Do not use this medicine together with the following medicines: alfuzosin (Uroxatral®), cisapride (Propulsid®), drospirenone (Yasmin®, Yaz®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), St. John's wort, tadalafil (Adcirca®), triazolam (Halcion®), certain medicines to lower cholesterol (such as lovastatin, simvastatin, Mevacor®, or Zocor®), medicines to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), or ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, DHE 45®, Ergomar®, Ergotrate®, or Methergine®). Using boceprevir with any of these medicines can cause very serious medical problems.

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Use all of the medicines your doctor has prescribed to treat hepatitis C infection. Boceprevir by itself will not treat hepatitis C.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use it, and it is less than 2 hours before your next dose, wait until then to take the medicine and skip the missed dose. If you miss a dose and it is more than 2 hours before your next dose, go ahead and take the missed dose and then take the next dose as scheduled. Ask your pharmacist or doctor if you have any questions about this.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using digoxin (Lanoxin®), medicine for heart rhythm problems (such as amiodarone, bepridil, flecainide, propafenone, quinidine, Cardioquin®, Cordarone®, Quinaglute®, Rythmol®, Tambocor®, or Vascor®), certain blood pressure medicine (such as amlodipine, felodipine, nicardipine, nifedipine, nisoldipine, Adalat®, Cardene®, Norvasc®, Plendil®, or Sular®), medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, Biaxin®, Nizoral®, Noxafil®, Sporanox®, or Vfend®), or a blood thinner (such as warfarin or Coumadin®).
• Tell your doctor if you are also using medicine to treat depression (such as desipramine, trazodone, Desyrel®, or Norpramin®), medicine to treat HIV or AIDS (such as atazanavir, darunavir, efavirenz, lopinavir, ritonavir, Kaletra®, Norvir®, Prezista®, Reyataz®, or Sustiva®), medicine to treat impotence (such as sildenafil, tadalafil, vardenafil, Cialis®, Levitra®, or Viagra®), alprazolam (Xanax®), bosentan (Tracleer®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), methadone (Dolophine®), midazolam injection, sirolimus (Rapamune®), tacrolimus (Prograf®), or birth control pills.
• Make sure your doctor knows if you are also using atorvastatin (Lipitor®), buprenorphine (Buprenex®), colchicine (Colcrys®), rifabutin (Mycobutin®), salmeterol (Serevent®), or a steroid medicine (such as budesonide, dexamethasone, fluticasone, Decadron®, Flonase®, Pulmicort®, or Rhinocort®).

Warnings While Using This Medicine

• You must have a negative pregnancy test before you use this medicine. Using this medicine while you are pregnant can harm your unborn baby. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Tell your doctor right away if a pregnancy occurs.
• Birth control pills may not work while you use this medicine. Use 2 other forms of birth control to prevent pregnancy during treatment and for 6 months after treatment ends. You should test for pregnancy every month during treatment.
• Make sure your doctor knows if you have anemia or neutropenia.
• Check with your doctor right away if you have chills, headache, pale skin, trouble breathing, or unusual tiredness or weakness. These could be symptoms of anemia.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Do not change or suddenly stop using this medicine without checking first with your doctor.
• This medicine will not keep you from giving hepatitis C to other people. Follow your doctor's instructions to prevent the spread of this infection.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, and body aches
• Pale skin
• Shortness of breath or troubled breathing
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Decreased appetite
• Diarrhea, nausea, or vomiting
• Hair loss
• Tiredness
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088