Victrelis

Victrelis is a prescription medication used along with other medications to treat chronic hepatits C. Victrelis belongs to a group of drugs called protease inhibitors which work by decreasing the amount of hepatitis C virus in the body by preventing the virus from replicating.

This medication comes in capsule form and is usually taken 3 times daily, with a meal or snack.

Common side effects of Victrelis include tiredness, nausea, and headaches.

Victrelis is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (long-lasting) hepatitis C infection in adults who have not been treated before, or whose condition did not improve with previous treatment.

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

• Merck Sharp & Dohme Corp.

Victrelis may cause serious side effects, including:

See "Drug Precautions" section.

Blood problems. Victrelis can affect your bone marrow and cause low red blood cell, and low white blood cell, counts. In some people, these blood counts may fall to dangerously low levels. If your blood cell counts become very low, you can get anemia or infections.

The most common side effects of Victrelis in combination with peginterferon alfa and ribavirin include:

• tiredness
• nausea
• headache
• change in taste

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Victrelis. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Victrelis and other medicines may affect each other, causing serious and/or life-threatening side effects or affecting the way Victrelis and your other medicines work. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

Do not take Victrelis if you take:

• alfuzosin hydrochloride (Uroxatral)
• anti-seizure medicines:
  • carbamazepine (Equetro, Tegretol)
  • phenobarbital
  • phenytoin (Dilantin)
• cisapride (Propulsid)
• drosperinone-containing medicines, including:
  • Yaz, Yasmin, Zarah, Ocella, Gianvi, Beyaz, Angeliq, Syeda, Safyral
• ergot-containing medicines, including:
  • dihydroergotamine mesylate (D.H.E. 45, Migranal)
  • ergonovine and methylergonovine (Ergotrate, Methergine)
  • ergotamine tartrate (Cafergot, Migergot, Ergomar, Ergostat, Medihaler Ergotam, Wigraine, Wigrettes)
• lovastatin (Advicor, Altoprev, Mevacor)
• midazolam (Versed), when taken by mouth
• pimozide (Orap)
• rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• sildenafil (Revatio), when used for treating lung problems
• simvastatin (Simcor, Vytorin, Zocor)
• St. John's Wort (Hypericum perforatum) or products containing St. John's Wort
• tadalafil (Adcirca), when used for treating lung problems
• triazolam (Halcion)

Tell your healthcare provider if you are taking or starting to take any of these medicines:

• atazanavir (Reyataz)
• clarithromycin (Biaxin, Prevpac)
• darunavir (Prezista)
• dexamethasone
• efavirenz (Sustiva, Atripla)
• etravirine (Intelence)
• itraconazole (Onmel, Sporanox)
• ketoconazole (Nizoral)
• lopinavir (Kaletra)
• posaconazole (Noxafil)
• rifabutin (Mycobutin)
• ritonavir (Norvir, Kaletra)
• voriconazole (Vfend)

Your healthcare provider may need to monitor your therapy more closely if you take Victrelis with the following medicines. Talk to your doctor if you are taking or starting to take these medicines:

• alprazolam (Xanax)
• amiodarone (Cordarone, Nexterone, Pacerone)
• atorvastatin (Lipitor)
• bepridil (Vascor)
• bosentan (Tracleer)
• budesonide (Pulmicort, Rhinocort, Symbicort)
• buprenorphine (Butrans, Buprenex, Suboxone, Subutex)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• desipramine (Norpramin)
• digoxin (Lanoxin)
• escitalopram (Lexapro)
• felodipine (Plendil)
• flecainide (Tambocor)
• fluticasone (Veramyst, Flovent, Advair)
• hormonal forms of birth control, including birth control pills, vaginal rings, implants and injections
• hormone replacement therapy
• methadone (Dolophine)
• naloxone
• nifedipine (Procardia, Adalat CC, Afeditab CR)
• nicardipine (Cardene)
• omeprazole
• prednisone
• oral and IV prednisolone
• pravastatin (Pravachol)
• propafenone (Rhythmol)
• quinidine
• raltegravir (Isentress)
• salmeterol (Serevent, Advair)
• sildenafil (VIagra), when used for treating erectile dysfunction
• sirolimus (Rapamune)
• tacrolimus (Prograf)
• tadalafil (Cialis), when used for treating erectile dysfunction
• colchicine (Colcrys, Probenecid and Colchicine, Col-Probenecid)
• trazodone (Desyrel)
• vardenafil (Staxyn, Levitra)
• warfarin (Coumadin)

Victrelis, in combination with peginterferon alfa and ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Victrelis, peginterferon alfa, and ribavirin combination therapy and for 6 months after treatment is over.

• Females and males must use 2 forms of birth control during treatment and for 6 months after treatment with Victrelis, peginterferon alfa, and ribavirin. Hormonal forms of birth control, such as birth control pills, vaginal rings, implants and injections, may not work as well during treatment with Victrelis. You may get pregnant while using these birth control methods while on Victrelis. Talk to your healthcare provider about other forms of birth control that may be used during this time.
• Females must have a pregnancy test before starting treatment with Victrelis combination therapy, every month while being treated, and every month for 6 months after treatment with Victrelis, peginterferon alfa, and ribavirin is over.
• If you or your female sexual partner becomes pregnant while taking Victrelis, peginterferon alfa, and ribavirin or within 6 months after you stop taking these medicines, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214. The Ribavirin Pregnancy Registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.

Do not take Victrelis if you:

• have had an allergic reaction to Victrelis or any of the ingredients in Victrelis.
• are treating chronic hepatitis C infection. Victrelis must be used with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.
• take certain medicines. Victrelis may cause serious side effects when taken with certain medicines. Read the section "Drug Interactions".

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Victrelis there are no specific foods that you must exclude from your diet when receiving Victrelis.

Before you take Victrelis, tell your healthcare provider if you:

• have certain blood disorders such as anemia (low red blood cell count).
• have liver problems other than hepatitis C infection.
• have human immunodeficiency virus (HIV) or any other immunity problems.
• have had an organ transplant.
• plan to have surgery.
• have any other medical condition
• are breastfeeding. It is not known if Victrelis passes into breast milk. You and your healthcare provider should decide if you will take Victrelis or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. Victrelis, in combination with peginterferon alfa and ribavirin, may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking Victrelis, peginterferon alfa, and ribavirin combination therapy and for 6 months after treatment is over.

See "Drug Precautions."

Tell your healthcare provider if you are breastfeeding. It is not known if Victrelis passes into breast milk. You and your healthcare provider should decide if you will take Victrelis or breastfeed. You should not do both.

• Take Victrelis exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to take and when to take it.
• Take Victrelis with food (a meal or light snack).
• Victrelis is packaged into single daily-use bottles. Each bottle has your entire day's worth of medicine. Make sure you are taking the correct amount of medicine each time.
• If you miss a dose of Victrelis and it is less than 2 hours before the next dose, the missed dose should be skipped.
• If you miss a dose of Victrelis and it is more than 2 hours before the next dose, take the missed dose with food. Take your next dose at your normal time and continue the normal dosing schedule. Do not double the next dose. If you have questions about what to do, call your healthcare provider.
• Your healthcare provider should do blood tests before you start treatment, at weeks 4, 8, 12, and 24, and at other times as needed during treatment, to see how well the medicines are working and to check for side effects.
• If you take too much Victrelis, call your healthcare provider or go to the nearest hospital emergency room right away.

Victrelis must be administered in combination with peginterferon alfa and ribavirin. The dose of Victrelis is 800 mg (four 200-mg capsules) three times daily (every 7 to 9 hours) with food. The length of Victrelis treatment varies depending several factors. Your healthcare provider will check your viral levels at weeks 8, 12, and 24 to determine your optimal duration of treatment.

If you take too much Victrelis call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Victrelis is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store Victrelis capsules in a refrigerator at 36°–46°F (2–8°C). Safely throw away refrigerated Victrelis after the expiration date.
• Victrelis capsules may also be stored at room temperature up to 77°F (25°C) for 3 months.
• Keep Victrelis in a tightly closed container and away from heat.
• Keep Victrelis and all medicines out of the reach of children.