Boceprevir (boe-SE-pre-vir)

Treats hepatitis C. Used together with peginterferon alpha and ribavirin.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If it is less than 2 hours before your next dose, wait until then to take the medicine and skip the missed dose. If it is more than 2 hours before your next dose, take the missed dose. Then take the next dose as scheduled. Ask your pharmacist or doctor if you have any questions about this.
• Store the medicine in a closed container in the refrigerator. You may also store it at room temperature, away from heat, moisture, and direct light, for up to 3 months.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with alfuzosin, carbamazepine, cisapride, doxazosin, drospirenone, lovastatin, lurasidone, oral midazolam, phenobarbital, phenytoin, pimozide, rifampin, sildenafil, silodosin, simvastatin, St John's wort, tadalafil, tamsulosin, triazolam, or ergot medicines.
• Some medicines can affect how boceprevir works. Tell your doctor if you are using any of the following:
  • Alprazolam, bosentan, clarithromycin, colchicine, cyclosporine, desipramine, digoxin, escitalopram, methadone, midazolam injection, rifabutin, salmeterol, sirolimus, tacrolimus, or trazodone
  • Birth control pills
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Medicine for heart rhythm problems
  • Medicine to lower cholesterol (including atorvastatin, pravastatin)
  • Medicine to treat a fungal infection
  • Medicine to treat HIV/AIDS
  • Medicine to treat impotence
  • Steroid medicine (including budesonide, dexamethasone, fluticasone, prednisone)

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. You must use 2 forms of birth control during your treatment and for 6 months after treatment ends.
• Tell your doctor if you are breastfeeding, or if you have other liver problems (such as liver failure).
• This medicine may cause the following problems:
  • Anemia
  • Neutropenia or pancytopenia (low blood cell counts)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blistering, peeling, red skin rash
• Fever, chills, cough, sore throat, body aches
• Pale skin, trouble breathing, dizziness, fainting
• 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, vomiting
• Hair loss
• Tiredness or joint pain
• 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