Victrelis

What is Victrelis?

Victrelis, an antiviral medicine, prevents the spread of certain viruses in your body.Victrelis can be used with peginterferon and ribavirin or sofosbuvir in combination to treat adults with hepatitis C type 1.Before changing your medication schedule or dose, consult your doctor.Victrelis can be used in other ways not mentioned in this guide.

Warnings

Victrelis can be used in conjunction with peginterferon-alfa (PEGIDA) and ribavirin.Ribavirin may cause birth defects or even death in an unborn child.Boceprevir can cause interactions with other medicines. Inform your doctor of all the medicines you are taking, as well as any new ones.

Before you take this drug

Victrelis should not be used if you have an allergy to boceprevir.

Victrelis is not the only medicine you should take to treat hepatitis. Victrelis should be taken in conjunction with peginterferon-alfa and ribavirin. You should read the patient instructions or medication guide that come with every medicine. You may not be allowed to take this combination of drugs in some situations.

Certain medicines may cause dangerous or unwanted effects when Victrelis is used. Your doctor might need to alter your treatment plan if any of these drugs are taken:

• Cisapride;
• Drospirenone
• Lurasidone (or pimozide)
• Rifampin;
• John's Wort;
• Alfuzosin, doxazosin, silodosin, and tamsulosin;
• Lovastatin or simvastatin;
• Oral midazolam (triazolam) or its equivalent
• Ergonovine, ergotamine, dihydroergotamine, and methylergonovine;
• The seizure medication carbamazepine or phenobarbital
• When used for the treatment of pulmonary arterial hypertension, sildenafil or tadalafil can be prescribed.

Tell your doctor about any of the following to ensure that you can take Victrelis safely:

• Liver problems other than hepatitis C;
• A history of liver transplantation or another organ transplant;
• Low levels of white blood cells (WBC), red blood cells (RBC), or platelets.

Victrelis, interferon alfa, and ribavirin are given together. Ribavirin may cause birth defects in unborn babies or even death. A negative pregnancy test is required before taking these medications and each month throughout your treatment.

• You should not take ribavirin while pregnant if you're a woman.
• You should not take ribavirin as a male if you have a sexual partner who is pregnant. A man who fathers a child while taking ribavirin could harm the unborn child.
• Both partners must use at least two effective methods of contraception while using ribavirin. Continue to use two birth control methods for at least six months after the treatment has ended. If you become pregnant while using ribavirin, either as a mother or father, tell your doctor immediately.
• It is possible that hormonal contraception (birth control pills, skin patches, implants, injections, and vaginal rings) may not be enough to prevent pregnancy while you are on ribavirin. Ask your doctor if you can use a method of birth control that is not hormonal (such as a diaphragm or IUD with spermicide or a condom) to prevent pregnancy when taking ribavirin.
• If you become pregnant while using ribavirin, either as a mother or father, tell your doctor immediately.

Boceprevir does not pass into breast milk. It is unknown if this drug could harm a baby who is nursing. Victrelis should not be used while breastfeeding.

How to take Victrelis?

Victrelis can be used in conjunction with peginterferon and ribavirin. Please follow all the instructions on the prescription label. Your doctor may occasionally adjust your dosage. Take these medications only as prescribed. Do not exceed the recommended dose or take them longer.You should read the patient instructions or medication guide that comes with your combination therapy. You should not alter your medication or dose schedule without consulting your doctor. Everyone with chronic hepatitis should be under the care and supervision of a physician.

Victrelis can be taken with or without food. Victrelis' usual dosage is 4 capsules, taken three times per day every 7 to nine hours. Please follow your doctor's advice.Victrelis contains 12 capsules per day. Victrelis comes in a carton with 28 bottles, which is enough for four weeks.You will need to have frequent blood tests in order to be certain that this medication is helping you. These tests may lead to the termination of Victrelis treatment.

Tell your surgeon that you use Victrelis before you have surgery.Do not freeze Victrelis capsules. After the expiration date is passed, throw away any capsules that are still unused.Store the capsules at room temperature for up to three months. Keep the capsules away from heat.

Details on dosage

Adult Victrelis Dosage:

Orally, 800 mg 3 times per day (spaced 7 to 9 hours) with food

DURATION OF THE THERAPY
Interferon-Ribavirin Therapy in Patients Without Cirrhosis who Have Failed or Are Untreated Previously (HCV-RNA Levels should be monitored during treatment weeks 8, 12, and 24 for determining the duration of treatment and assessing treatment futility).
Patients who have not been treated before:
-HCV RNA not detected in tws 8 or 24: 3-drug regimen complete (boceprevir peginterferon, ribavirin, and peginterferon-alfa) at TW28
-HCV RNA was detected in TW 8 but not detected in TW 24. Continue with all 3 drugs through TW 36, and then finish using peginterferon and ribavirin through TW 48.
If the interferon response is poor at TW 4, consider using a 3-drug regimen over 44 weeks to maximize rates of sustained viral response (SVR).
Relapsed or partial responders in the past:
-HCV RNA is not detected in tws 8 or 24: complete 3-drug regimen by TW 36.
-HCV RNA was detected in TW 8 but not detected in TW 24. Continue with all 3 drugs through TW 36, and then finish using peginterferon and ribavirin through TW 48.
Previous null respondents:
-HCV RNA detected or non-detected at TW 8 and not detected by TW 24; continue all three drugs through TW 48.
Patients with compensated cysts:
The 3-drug regimen is to be used for a total of 44 weeks.
TREATMENT FUTILITY
All patients who have (a) HCV RNA levels of at least 1000 International Units/ml by TW 8; (b) HCV RNA levels of at least 100 International Units/ml by TW 12; or (c) confirmed detectable levels of HCV RNA at TW 24 are recommended to stop the therapy.
COMMENTS:
The first 4 weeks of treatment should include peginterferon and ribavirin. Boceprevir can be added after this period.
The duration of treatment is determined by the viral response, previous response status, and the presence of cirrhosis.
Poorly interferon-responsive patients using this regimen were less likely to reach SVR and had higher detection of resistance-associated mutations upon treatment failure compared with patients who responded better, similar in both quality and quantity of treatment response. Greater response to peginterferon alfa and ribavirin.
Before starting treatment, it is important to carefully consider the risks and benefits of this regimen in patients with compensated liver cirrhosis whose platelet count was less than 100,000/mm3 at baseline and whose serum albumin level was less than 3,5 g/dl.
Use: To treat chronic hepatitis C, genotype 1, in combination with peginterferon-alfa and ribavirin in patients with compensated cirrhosis or untreated liver disease, including those who failed prior interferon therapy and/or ribavirin. This includes previous null responders and partial responders, as well as relapsers.

What happens if I miss the dose?

As soon as you recall, take the missed dose. If your next dose will be in less than two hours, skip the missed dose. You should not take more medicine to compensate for a missed dose.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

Avoid this

Victrelis does not protect you from spreading hepatitis C. Share razors and toothbrushes. Do not engage in unprotected sexual activity. Speak to your doctor about the best ways to avoid transmission during sex. Even healthy people should never share syringes or needles.

Side effects of Victrelis

If you experience any of the following symptoms of an allergic reaction after taking Victrelis, seek immediate medical attention: hives, difficulty breathing, swelling of the face, lips, or tongue, and swelling of your throat.

You should read all your medication guides in order to find out about any possible side effects from other medications that you may be taking with Victrelis. If you have questions, speak to your physician or pharmacist immediately.

Victrelis should be stopped immediately, and you should consult your doctor if:

• Tiredness, weakness, and confusion
• Easy bruising and bleeding (nosebleeds, bleeding gums);
• Pale skin, rapid heartbeat, feeling of being light-headed, having trouble concentrating, or
• Flu symptoms include fever, chills, and body aches. Sores on your tongue and throat are also common.

Victrelis may cause the following side effects:

• Headache;
• Changed sense of taste

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Boceprevir can interact with many drugs. Some drugs should never be taken together. Tell your doctor if you are taking any new medicines or if you will stop using them. This is especially important if the medicines are for treating:

• Infections;
• Asthma or allergies
• Depression, anxiety, and sleep disorders
• High cholesterol, heart problems, and high blood pressure are all symptoms of high cholesterol.
• Blood clots
• HIV or AIDS organ transplant rejection
• Severe pain
• Erectile dysfunction;
• Hypertension pulmonary arterial;
• Swelling, inflammation,
• A hormonal imbalance.

Boceprevir can interact with many other drugs. Included are prescription and non-prescription medicines, vitamins, and herbal products. This medication guide does not list all possible interactions. Inform your doctor of all the medicines you take, including those that you stop or start using during Victrelis treatment. Provide a list to all healthcare providers who treat you.