Victrelis is an antiviral medicine that prevents certain viruses from multiplying in your body.

Victrelis is used in combination with peginterferon alfa and ribavirin, or with sofosbuvir to treat hepatitis C genotype 1 in adults.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice.

Victrelis may also be used for purposes not listed in this medication guide.

Victrelis is used in combination with other medications called peginterferon alfa and ribavirin.

Do not use Victrelis with peginterferon alfa and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant. Ribavirin can cause birth defects or death in an unborn baby.

Some medicines can interact with boceprevir and should not be used at the same time. Tell your doctor about all your current medicines and any you start or stop using.

Victrelis is used in combination with peginterferon alfa and ribavirin. Follow all directions on your prescription label. Your doctor may occasionally change your doses. Do not take these medicines in larger or smaller amounts or for longer than recommended.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with chronic hepatitis C should remain under the care of a doctor.

Take Victrelis with food. The usual dose of Victrelis is 4 capsules taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.

Your total daily dose of 12 capsules is contained in a single bottle of Victrelis. A carton of Victrelis contains 28 bottles for a 4-week supply.

To be sure this medicine is helping your condition, you will need frequent blood tests. Treatment with Victrelis may be discontinued based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using Victrelis.

Store Victrelis capsules in the refrigerator, do not freeze. Throw away any unused capsules after the expiration date on the label has passed.

You may also store the capsules at room temperature for up to 3 months. Protect the capsules from heat.

Usual Adult Dose of Victrelis for Chronic Hepatitis C:

800 mg orally 3 times a day (7 to 9 hours apart) with food

DURATION OF THERAPY:
In Patients without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy (HCV-RNA levels should be monitored at treatment weeks [TWs] 8, 12, and 24 to determine duration of therapy and assess for treatment futility):
Previously untreated patients:
-HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen (boceprevir, peginterferon alfa, ribavirin) at TW 28.
-HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.
-Poorly interferon responsive at TW 4: Consider using 3-drug regimen for 44 weeks (to maximize rates of sustained virologic response [SVR]).

Previous partial responders or relapsers:
-HCV-RNA not detected at TWs 8 and 24: Complete 3-drug regimen at TW 36.
-HCV-RNA detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 36, and then use peginterferon alfa and ribavirin and finish through TW 48.

Previous null responders:
-HCV-RNA detected or not detected at TW 8 and not detected at TW 24: Continue all 3 drugs and finish through TW 48.

In Patients with Compensated Cirrhosis:
-The 3-drug regimen should be used for 44 weeks.

TREATMENT FUTILITY:
-Therapy discontinuation is recommended in all patients with (a) HCV-RNA levels at least 1000 international units/mL at TW 8, or (b) HCV-RNA levels at least 100 international units/mL at TW 12, or (c) confirmed detectable HCV-RNA levels at TW 24.

COMMENTS:
-Therapy should be initiated with peginterferon alfa and ribavirin for 4 weeks; boceprevir should be added to the regimen after the initial 4 weeks of therapy.
-Duration of therapy is based on viral response, prior response status, and presence of cirrhosis.
-Poorly interferon responsive patients using this regimen are less likely to achieve SVR, and have a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.
-The risks/benefits of this regimen should be carefully considered before starting therapy in patients with compensated cirrhosis who have platelet count less than 100,000/mm3 and serum albumin less than 3.5 g/dL at baseline.

USE: For the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy, including prior null responders, partial responders, and relapsers

You should not use Victrelis if you are allergic to boceprevir.

Do not take Victrelis as your only hepatitis medicine. Victrelis must be used in combination with peginterferon alfa and ribavirin. Read the medication guide or patient instructions provided with each medicine you take. In some cases, you may not be able to use this drug combination.

Some medicines can cause unwanted or dangerous effects when used with Victrelis. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cisapride;

• drospirenone (Yasmin, Yaz, Beyaz, Angeliq, and others);

• lurasidone or pimozide;

• rifampin;

• St. John's wort;

• alfuzosin, doxazosin, silodosin, tamsulosin;

• lovastatin or simvastatin;

• oral midazolam or triazolam;

• ergonovine, ergotamine, dihydroergotamine, methylergonovine;

• the seizure medications carbamazepine, phenobarbital, or phenytoin; or

• sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension.

To make sure you can safely take Victrelis, tell your doctor if you have:

• liver problems other than hepatitis C (including hepatitis B);

• a history of liver or other organ transplant; or

• low white blood cell (WBC) or red blood cell (RBC) counts, or low levels of platelets in in your blood.

Victrelis is given together with interferon alfa and ribavirin. Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before using these medications together, and every month during your treatment.

• If you are a woman, do not use ribavirin if you are pregnant.

• If you are a man, do not use ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

• Use at least 2 effective forms of birth control while either sexual partner is using ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

• Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking ribavirin.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.

It is not known whether boceprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Victrelis.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking Victrelis will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Get emergency medical help if you have signs of an allergic reaction to Victrelis: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Read all of your medication guides to learn about possible side effects of other medications you use in combination with Victrelis. Ask your doctor or pharmacist if you have any questions.

Stop using Victrelis and call your doctor at once if you have:

• tired feeling, weakness, confusion;

• easy bruising or bleeding (nosebleed, bleeding gums);

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Common Victrelis side effects may include:

• headache;

• altered sense of taste; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with boceprevir, and some drugs should not be used together. Tell your doctor about all your current medicines and any you start or stop using, especially medicines to treat:

• infections;

• asthma or allergies;

• depression, anxiety, sleep problems;

• high cholesterol, heart problems, high blood pressure;

• blood clots;

• HIV or AIDS, organ transplant rejection;

• severe pain;

• erectile dysfunction;

• pulmonary arterial hypertension;

• swelling, inflammation; or

• a hormonal imbalance.

This list is not complete and many other drugs can interact with boceprevir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Victrelis. Give a list of all your medicines to any healthcare provider who treats you.