Boceprevir

Brand Name(s):

• Victrelis®

IMPORTANT WARNING:

[Posted 3/1/2012]ISSUE:FDA notified healthcare professionals of updates to the prescribing information concerning interactions between protease inhibitors and certain statin drugs. Protease inhibitors and statins taken together may raise the blood levels of statins and increase the risk for muscle injury (myopathy). The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.

BACKGROUND:Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (''bad cholesterol''). HIV protease inhibitors are a class of prescription anti-viral drugs used to treat HIV. HCV protease inhibitors are a class of prescription anti-viral drugs used to treat hepatitis C infection.

RECOMMENDATION:Healthcare professionals should follow the recommendations in the prescribing information (drug labels) when prescribing HIV or HCV protease inhibitors with statins. See the FDA Drug Safety Communication for additional information, including a data summary. For more information visit the FDA website at: Web Siteand Web Site.

[Posted 02/09/2012]ISSUE:FDA notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together.

A drug interaction study showed that taking boceprevir (Victrelis) with ritonavir (Norvir) in combination with atazanavir (Reyataz) or darunavir (Prezista), or with Kaletra (lopinavir/ritonavir) reduced the blood levels of the HIV medicines and boceprevir in the body. FDA will be updating the boceprevir drug label to include information about these drug interactions.

BACKGROUND:Boceprevir is a hepatitis C virus (HCV) protease inhibitor used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults. HIV protease inhibitors are a class of anti-viral drugs used to treat HIV infection. Ritonavir is an HIV protease inhibitor used to boost other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

RECOMMENDATION:Patients should not stop taking any of their medicines without talking to their healthcare professional. Patients should contact their healthcare professional if they have any questions or concerns.

Healthcare professionals who have started patients infected with both chronic HCV and HIV on boceprevir and antiretroviral therapy containing a ritonavir-boosted protease inhibitor should closely monitor patients for HCV treatment response and for potential HCV and HIV virologic rebound. For more information visit the FDA website at: Web Siteand Web Site.

WHY is this medicine prescribed?

Boceprevir is used along with two other medications (ribavirin [Copegus, Rebetol] and peginterferon alfa [Pegasys]) to treat chronic hepatitis C (an ongoing viral infection that damages the liver) in people who have not yet been treated for this condition or whose condition did not improve when they were treated with ribavirin and peginterferon alfa alone. Boceprevir is in a class of medications called protease inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Boceprevir may not prevent the spread of hepatitis C to other people.

HOW should this medicine be used?

Boceprevir comes as a capsule to take by mouth. It is usually taken with a meal or light snack three times a day (every 7 to 9 hours). Take boceprevir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take boceprevir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You will take peginterferon alfa and ribavirin for 4 weeks before you begin treatment with boceprevir. Then you will take all three medications for 12 to 44 weeks. After this time, you will stop taking boceprevir, but you may continue to take peginterferon alfa and ribavirin for an additional number of weeks. The length of your treatment depends on your condition, how well you respond to the medication, and whether you experience severe side effects. Continue to take boceprevir, peginterferon alfa, and ribavirin as long as they are prescribed by your doctor. Do not stop taking any of these medications without talking to your doctor even if you are feeling well.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with boceprevir and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking boceprevir,

• tell your doctor and pharmacist if you are allergic to boceprevir, any other medications, or any of the ingredients in boceprevir capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor if you are taking any of the following medications or herbal products: alfuzosin (Uroxatral); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine, ergotamine (Ergomar, in Cafergot, in Migergot) or methylergonovine; cisapride (Propulsid) (not available in the U.S.); drospirenone (in some oral contraceptives such as Beyaz, Gianvi, Ocella, Safyral, Yasmin, Yaz, and Zarah); lovastatin (Altoprev, Mevacor); certain medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, or phenytoin (Dilantin); midazolam taken by mouth; pimozide (Orap); rifampin (Rifadin, Rimactane, in IsonaRif, in Rifamate, in Rifater); sildenafil (only Revatio brand used for lung disease); simvastatin (Simcor, in Vytorin); tadalafil (only Adcirca brand used for lung disease); St. John's wort; or triazolam (Halcion). Your doctor will probably tell you not to take boceprevir if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alprazolam (Niravam, Xanax); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); atorvastatin (Lipitor, in Caduet); bosentan (Tracleer); budesonide (Pulmicort, Rhinocort, Symbicort); buprenorphine (Buprenex, Butrans, Subutex, Suboxone); clarithromycin (Biaxin); colchicine (Colcrys, in Col-Probenecid); calcium channel blockers such as felodipine (Plendil), nicardipine (Cardene), and nifedipine (Adalat, Afeditab, Procardia); cyclosporine (Gengraf, Neoral, Sandimmune); desipramine (Norpramin); dexamethasone; certain medications for erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn); certain medications for HIV such as efavirenz (Sustiva, in Atripla) and ritonavir (Norvir, in Kaletra); certain medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), bepridil (Vascor) (not available in the U.S.), digoxin (Lanoxin), flecainide (Tambocor), propafenone (Rhythmol), and quinidine; methadone (Dolophine, Methadose); midazolam given intravenously (into a vein); rifabutin (Mycobutin); salmeterol (Serevent, in Advair); sirolimus (Rapamune); and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had an organ transplant, and if you have or have ever had anemia (not enough red blood cells in the blood to carry oxygen to the rest of the body), human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), any other condition that affects your immune system, or hepatitis B (a viral infection that damages the liver) or any type of liver disease other than hepatitis C.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking boceprevir.
• tell your doctor if you are pregnant, plan to become pregnant, or can possibly become pregnant. If you are male, tell your doctor if your partner is pregnant, plans to become pregnant, or can possibly become pregnant. Boceprevir must be taken with ribavirin which can seriously harm the fetus. You must use two methods of birth control to prevent pregnancy in you or your partner during your treatment with these medications and for 6 months after your treatment. Talk to your doctor about which methods you should use; hormonal contraceptives (birth control pills, patches, implants, rings, or injections) may not work well in women who are taking these medications. You or your partner must be tested for pregnancy every month during your treatment and for 6 months after your treatment. If you or your partner become pregnant while taking these medications, call your doctor immediately.
• tell your doctor if you are breast-feeding.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose with food as soon as you remember it. However, if it is 2 hours or less before the scheduled time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. You may store the capsules at room temperature and away from excess heat and moisture (not in the bathroom) for up to three months. You can also store the capsules in the refrigerator until the expiration date printed on the label has passed. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to boceprevir.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2012.