Boceprevir

boe-SE-pre-vir

Commonly used brand name(s)

In the U.S.

• Victrelis

Available Dosage Forms:

• Capsule

Pharmacologic Class: Protease Inhibitor

Uses For boceprevir

Boceprevir is used in combination with injectable peginterferon alfa (Pegasys®, Pegintron®) and ribavirin (Copegus®, Rebetol®) to treat chronic hepatitis C infection. These medicines are used in patients with compensated liver disease (including cirrhosis), who have not been treated before or who have received other medicines but did not work well. Boceprevir is a direct-acting antiviral agent that treats hepatitis C infection.

boceprevir is available only with your doctor's prescription.

Before Using boceprevir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For boceprevir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to boceprevir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of boceprevir in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of boceprevir have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver problems, which may require caution in patients receiving boceprevir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking boceprevir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using boceprevir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Carbamazepine


• Cisapride


• Colchicine


• Dihydroergotamine


• Drospirenone


• Ergonovine


• Ergotamine


• Lovastatin


• Methylergonovine


• Midazolam


• Phenobarbital


• Phenytoin


• Pimozide


• Rifampin


• Sildenafil


• Simvastatin


• St John's Wort


• Tadalafil


• Triazolam

Using boceprevir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam


• Amiodarone


• Bepridil


• Budesonide


• Dexamethasone


• Digoxin


• Efavirenz


• Ethinyl Estradiol


• Flecainide


• Fluticasone


• Itraconazole


• Posaconazole


• Propafenone


• Quinidine


• Rifabutin


• Ruxolitinib


• Salmeterol


• Sirolimus


• Sunitinib


• Vardenafil


• Voriconazole

Using boceprevir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of boceprevir. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems (e.g., anemia, neutropenia)—Use with caution. May make these conditions worse.

Proper Use of boceprevir

To help clear up your infection completely, boceprevir must be taken together with peginterferon alfa and ribavirin for the full time of treatment, even if you begin to feel better after a few days. Also, it is important to keep the amount of medicine in your body at a steady level. To help keep the amount constant, boceprevir must be used on a regular schedule.

Take boceprevir with a meal or light snack.

Do not change or suddenly stop using boceprevir without checking first with your doctor.

boceprevir should come with a Medication Guide. Read and follow the information carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Dosing

The dose of boceprevir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of boceprevir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  
  • For hepatitis C virus infection, in combination with peginterferon alfa and ribavirin:
    
    • Adults—800 milligrams (mg) (four 200-mg capsules) three times a day with food. Each dose should be taken 7 to 9 hours apart.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of boceprevir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose or forget to use it, and it is less than 2 hours before your next regular 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 regular dose, go ahead and take the missed dose and take the next regular dose as scheduled. If you have any questions about this, ask your pharmacist or doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using boceprevir

It is very important that your doctor check your progress at regular visits to make sure boceprevir is working properly. Blood tests may be needed to check for unwanted effects.

Using boceprevir together with peginterferon alfa and ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

To make sure you are not pregnant, your doctor may ask you to have a pregnancy test before you start using boceprevir. You must have a negative pregnancy test before you will be allowed to use boceprevir with ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You should test for pregnancy every month while you are using boceprevir, and for 6 months after your treatment ends.

Birth control pills may not work while you are using boceprevir. To keep from getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Do not use boceprevir 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.

Check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin. These could be symptoms of a blood disorder called anemia.

Birth control pills may not work while you are using boceprevir. To keep from getting pregnant, use two other forms of birth control. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Using boceprevir can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Make sure any doctor or dentist who treats you knows that you are using boceprevir. boceprevir may affect the results of certain medical tests.

boceprevir will not keep you from giving hepatitis C to other people. Follow your doctor's instructions about how to prevent the spread of this infection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

boceprevir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools


• chills


• cough


• difficult or labored breathing


• fever


• lower back or side pain


• painful or difficult urination


• pale skin


• shortness of breath


• sore throat


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in taste


• decreased appetite


• diarrhea


• difficulty with moving


• dizziness


• dry mouth


• dry skin


• hair loss or thinning of the hair


• irritability


• lack or loss of strength


• loss of taste


• muscle pain or stiffness


• nausea


• pain in the joints


• rash


• sleeplessness


• trouble sleeping


• unable to sleep


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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