Victrelis

Victrelis is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon and ribavirin.

Victrelis is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use Victrelis if:

• you are allergic to any ingredient in Victrelis
• you are taking alfuzosin, certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, pimozide, rifampin, or St. John's wort
• you take sildenafil or tadalafil for pulmonary arterial hypertension (PAH)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Victrelis:

Some medical conditions may interact with Victrelis. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have HIV infection or other immune system problems; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)
• if you have other liver problems (eg, cirrhosis, hepatitis B infection)
• if you have had an organ transplant
• if you will be having surgery

Some MEDICINES MAY INTERACT with Victrelis. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), rifampin, or St. John's wort because they may decrease Victrelis's effectiveness
• Alfuzosin, certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, or pimozide because the risk of their side effects may be increased by Victrelis
• Sildenafil or tadalafil (when used to treat PAH) because the risk of their side effect may be increased by Victrelis
• Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Victrelis
• Many prescription medicines (eg, used for asthma or breathing problems, anxiety, blood thinning, blood flow, cancer, diabetes, enlarged prostate, erectile dysfunction, gout, heart problems, HIV, immune suppression, infections, inflammation, infection, irregular heartbeat, high blood pressure, high cholesterol, mental or mood problems, opioid dependence, pain [eg, narcotics], PAH, sleep) may interact with Victrelis, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Victrelis may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Victrelis:

Use Victrelis as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Victrelis comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Victrelis refilled.
• Victrelis must be taken with peginterferon and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.
• Take Victrelis by mouth with food (a meal or light snack).
• Victrelis is packaged into bottles that contain enough capsules for an entire day. Be sure you know how many capsules to take for each dose.
• Victrelis works best if it is taken at the same times each day.
• Continue to take Victrelis even if you feel well. Do not miss any doses.
• If you miss a dose of Victrelis, and it is more than 2 hours before your next dose, take the missed dose with food and go back to your regular dosing schedule. If you miss a dose of Victrelis, and it is less than 2 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Victrelis.

Important safety information:

• Victrelis may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Victrelis with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Victrelis may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Victrelis may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Victrelis does not stop you from spreading HCV to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have HCV infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors.
• Do not change your dose without checking with your doctor.
• Victrelis is not a cure for HCV infection. Remain under the care of your doctor.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Victrelis, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Women who may become pregnant and men who use Victrelis must use 2 effective forms of birth control while they take Victrelis with ribavirin and for 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using Victrelis. Talk with your doctor if you have questions about effective birth control.
• Tell your doctor or dentist that you take Victrelis before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including complete blood cell counts and HCV antibody levels, may be performed while you use Victrelis and for several months after you stop Victrelis. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Victrelis with caution in the ELDERLY; they may be more sensitive to its effects.
• Victrelis should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Victrelis must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Victrelis. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Victrelis while you are pregnant. It is not known if Victrelis is found in breast milk. Do not breast-feed while taking Victrelis.

Possible side effects of Victrelis:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in taste; decreased appetite; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; irritability; joint pain; nausea; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark, tarry, or bloody stools; fainting; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; pale skin; severe or persistent dizziness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Victrelis side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Store Victrelis in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Victrelis may also be stored at room temperature up to 77 degrees F (25 degrees C) for 3 months. Keep Victrelis in the original container. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Victrelis out of the reach of children and away from pets.

General information:

• If you have any questions about Victrelis, please talk with your doctor, pharmacist, or other health care provider.
• Victrelis is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Victrelis. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.