What Victrelis Triple is used for and how to use it
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Victrelis Triple - Consumer Medicine Information

Manufacture: Merck and Co., Inc.
Country: Canada
Condition: Hepatitis C, Hepatitis C, Chronic (Hepatitis C)
Class: Antiviral agents, Biologicals, Protease inhibitors
Form: Subcutaneous (SC), Capsules, Powder
Ingredients: boceprevir, ribavirin, peginterferon alfa-2b, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, and sodium lauryl sulfate, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide, polysorbate 80, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, and sucrose

boceprevir

ribavirin

plus

peginterferon alfa-2b

About This Medication

What the Medication is Used For

VICTRELIS TRIPLE is a prescription medicine used to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults who have not been previously treated or who have failed previous therapy. Patients with hepatitis C have the virus in their blood and in their liver.

It is not known if VICTRELIS TRIPLE is safe and effective when used in children less than 18 years of age.

What it Does

VICTRELIS TRIPLE therapy consists of 3 active medications in 2 drug products: VICTRELIS (boceprevir) and PEGETRON, (ribavirin and peginterferon alfa-2b).

Boceprevir is a medicine called a Hepatitis C Virus Protease Inhibitor that directly targets Hepatitis C Virus to reduce the amount of virus in your body.

Ribavirin is an antiviral agent (fights infection), but does not work when used by itself to treat chronic hepatitis C.

Peginterferon alfa-2b generally helps the body's immune system to fight infections.

It is not known exactly how ribavirin and peginterferon alfa-2b work together to fight the hepatitis C infection.

VICTRELIS TRIPLE therapy may reduce the amount of hepatitis C virus in the blood stream to below the level that can be measured by a laboratory test.

When it Should not Be Used

Do not use VICTRELIS TRIPLE:

  • If you or your partner are pregnant.
  • If you or your partner plan to become pregnant during treatment or during the 6 months after treatment.
  • If you or your partner become pregnant during treatment. VICTRELIS TRIPLE therapy can cause serious birth defects or harm to your unborn child. Therefore, both you and your partner must use effective contraception during this time.
  • If you are allergic to any of the ingredients in VICTRELIS TRIPLE (boceprevir, ribavirin or peginterferon alfa-2b) or to any of the nonmedicinal ingredients (see What the nonmedicinal ingredients are).
  • If you have autoimmune hepatitis (hepatitis caused by cells in your body attacking each other) or any other problem with your immune system; if you are taking medicine that suppresses your immune system (your immune system protects you against infection and some diseases).
  • If you have a severe nervous or mental disorder.
  • If you have thyroid disease that is not well controlled with medicines.
  • If you have advanced uncontrolled liver disease (other than hepatitis C) or liver failure.
  • If you have severe kidney disease.
  • If you have epilepsy.
  • If you are breastfeeding or planning to breastfeed.
  • If you are taking certain medicines. For more information about medicines that you should not take while using VICTRELIS TRIPLE, please see INTERACTIONS WITH THIS MEDICATION.

What the Medicinal Ingredients Are

  • boceprevir capsules
  • ribavirin capsules
  • peginterferon alfa-2b powder for solution

What the Non-medicinal Ingredients Are

Boceprevir capsules: Non-medicinal ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, and sodium lauryl sulfate. The capsule shell consists of gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The capsule is printed with red ink. The red ink contains red iron oxide and shellac.

Ribavirin capsules: Non-medicinal ingredients are croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The capsule shell contains gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide.

Peginterferon alfa-2b Powder for Solution in CLEARCLICK single dose delivery system: Nonmedicinal ingredients are polysorbate 80, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, and sucrose.

What Dosage Forms it Comes In

Each boceprevir capsule contains 200 mg of boceprevir.

Each ribavirin capsule contains 200 mg of ribavirin.

Peginterferon alfa-2b CLEARCLICK single dose delivery system consists of a dual-chamber glass cartridge with a chamber containing peginterferon alfa-2b as a white to offwhite lyophilized powder and another chamber containing Sterile Water for Injection. The cartridge is provided in a pen device for reconstitution, dose preparation and subcutaneous administration. It is available in strengths of 80, 100, 120, and 150 mcg for single use.

Warnings and Precautions

Serious Warnings and Precautions

Some people get depressed when taking pegylated interferon alfa-2b alone or in combination treatment with ribavirin, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.

In animals, significant harm to embryos (e.g. death) and teratogenic changes (e.g. malformed fetus) have occurred with ribavirin use. VICTRELIS TRIPLE must not be used by pregnant women and in men whose female partners are pregnant. Avoid pregnancy during treatment and for 6 months after treatment and the same conditions if you are a partner of a male patient.

Hemolytic anemia (release of hemoglobin from red blood cells) has occurred with ribivarin use, leading to decreased heart function and/or worsening of heart disease. This product should not be used if you have a history of significant or unstable heart disease.

What is the most important information I should know about VICTRELIS TRIPLE therapy?

  1. VICTRELIS TRIPLE therapy could cause serious birth defects or harm your unborn child.
    • If you or your partner are pregnant or planning to become pregnant, you should not receive VICTRELIS TRIPLE.
    • Pregnancy should not be planned while you or your partner are on therapy or for 6 months after therapy.
    • If you or your partner become pregnant while on therapy or during the 6 months after stopping therapy, consult your doctor immediately. Your doctor should call the Merck Canada Inc. Medical Information Department at 1-800-567-2594.
    • If you are a woman of childbearing age, you must have a negative pregnancy test before treatment and a pregnancy test each month during treatment.
    • Both you and your partner must use effective contraception during treatment and for the 6 months after treatment is completed. As systemic (e.g., oral, topical…) hormonal contraceptives may not work as well while taking VICTRELIS TRIPLE, use of 2 alternative methods of contraception, such as barrier method and intrauterine devices during treatment with VICTRELIS and ribavirin. You should discuss with your doctor how you or your partner can prevent getting pregnant.
  2. Ribavirin may cause anemia, which is a decrease in the number of red blood cells you have. Anemia may be increased when boceprevir is added to peginterferon alpha/ribavirin therapy. This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your doctor before taking VICTRELIS TRIPLE therapy if you have or have ever had any cardiovascular problems. Your healthcare provider will be checking your blood counts periodically for possible decreases in your blood count. Depending on the medications that you are taking, your healthcare provider may make changes to your current medicines or prescribe additional medicines to treat your anemia.
  3. Boceprevir may cause serious side effects when taken with other medications. It is important to know the medicines that should not be taken with boceprevir.
  4. Do not take boceprevir alone to treat chronic hepatitis C infection. Boceprevir should only be used with other medicines to treat chronic hepatitis C infection.

Medicines are sometimes prescribed for purposes other than those listed in this package leaflet. Remember, this medicine is for you and must be used as prescribed by your doctor. Never give it to anyone else.

BEFORE you use VICTRELIS TRIPLE talk to your doctor or pharmacist if you have any of the following medical conditions or other serious medical problems:

  • Previous heart attack, or other heart problems, becausetherapy may cause heart problems to become worse.
  • Blood disorders; including anemia (lack of enough healthy red blood cells), thalassemia (Mediterranean anemia), sickle-cell anemia, neutropenia (lack of a certain type of white blood cells) or pancytopenia (a combination of low platelet, red and white blood cellcounts) because therapy may further reduce the number of red and white blood cells you have. This may make you feel dizzy or weak and could worsen any heart problems you might have.
  • Kidney problems.
  • Liver problems (except hepatitis C infection).
  • Nervous or mental problems (such as depression, anxiety, etc.), because the therapy could make these problems worse.
  • Body organ transplant and are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system).
  • Thyroid disease.
  • Cancer.
  • Infection with hepatitis B virus and/or Human Immunodeficiency Virus (the virus that causes AIDS).
  • If you have had problems with your immune system.
  • If you have diabetes or high blood pressure, your doctor may ask you to have periodic eye examinations.
  • If you have high blood fat levels (such as elevated triglycerides or cholesterol levels).
  • If you had any serious illness affecting your breathing or your blood.
  • If you have psoriasis or sarcoidosis, it may become worse while you are using VICTRELIS TRIPLE.
  • If you have any other medical condition.
  • Be sure to tell your doctor about all the medications you are taking, including those without a prescription, and the Chinese herbal medication Shosaikoto (also known as Xiao-Chai-Hu-Tang).
  • If you are using any other medications.

VICTRELIS TRIPLE may cause a Reduction of Red Blood Cells a condition known as anemia, or a reduction of neutrophils (a type of white blood cell) a condition known as neutropenia. Anemia or neutropenia may be increased when VICTRELIS is added to your ribavirin therapy. Therefore, your healthcare provider will be checking your blood counts periodically for possible decreases in your blood cell counts. Depending on the medications that you are taking, your healthcare provider may make changes to your current medicines or prescribe additional medicines to treat your anemia, or neutropenia.

VICTRELIS TRIPLE may cause serious side effects when taken with other medications. It is important to know the medicines that should not be taken with VICTRELIS.

Dental and gum disorders, which may lead to loss of teeth, have been reported in patients who received VICTRELIS TRIPLE. In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with VICTRELIS TRIPLE. You should brush your teeth thoroughly twice daily and have regular dental examinations. In addition some patients may experience vomiting. If you have this reaction, be sure to rinse your mouth thoroughly afterwards.

While taking VICTRELIS TRIPLE, serious allergic reactions have been reported. Please see "What are the possible side effects of VICTRELIS TRIPLE therapy ?"

Interactions With This Medication

Drugs that may interact with ribavirin and/or peginterferon alfa-2b include: medications metabolized by CYP1A2, CYP2C8/9 and CYP2D6; reverse transcriptase inhibitors such as zidovudine and stavudine; purine nucleoside analogues such as didanosine and abacavir; and Highly Active Anti-Retroviral Therapy.

Co-administration of ribavirin capsules and didanosine is not recommended due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis.

Tell your doctor or pharmacist if you are taking SEBIVO (telbivudine) for chronic hepatitis B because taking this medicine together with pegylated interferon alfa-2b may increase your risk of developing peripheral neuropathy (numbness, weakness, tingling, and/or burning sensations, or pain in the arms and/or legs). The combined use of these medications is not recommended.

Do not take VICTRELIS TRIPLE if you take:

  • Alfuzosin, doxazosin, silodosin and tamsulosin – used to treat enlarged prostrate;
  • amiodarone, propafenone and quinidine – used for heart beat problems;
  • astemizole1, terfenadine1 – used to treat allergies, hives, itching and watery eyes;
  • birth control pills that contain drospirenone;
  • carbamazepine, phenobarbital, phenytoin – used to treat seizures and nerve pain;
  • cisapride1 – used to help with digestion;
  • ergot-containing medicines used to treat migraines, such as:
    • ergotamine,
    • dihydroergotamine,
    • ergonovine,
    • methylergonovine;
  • lovastatin, simvastatin – used for lowering high cholesterol and triglycerides;
  • oral midazolam, oral triazolam – used to help you sleep;
  • pimozide – used for mental health problems;
  • rifampin – used to treat tuberculosis or meningitis;
  • sildenafil and tadalafil – used for the treatment of pulmonary arterial hypertension;
  • St. John's wort (Hypericum perforatum) – an herbal product used to help with your mood.

1Please note that cisapride, astemizole and terfenadine are no longer available on the Canadian market.

Tell your doctor if you are taking any of the following medications as they may interact with boceprevir. The dosage of one or the other may have to be changed or the medication avoided:

  • Antifungals (e.g. ketoconazole, itraconazole), amlodipine, bepridil, birth control medicines (e.g. ethinyl estradiol/norethindrone), bosentan, budesonide, buprenorphine, clarithromycin, colchicine, cyclosporine, desipramine, dexamethasone, digoxin, diltizem, escitalopram, felodipine, fluticasone, methadone, nicardipine, nifedipine, nisoldipine, rifabutin, salmeterol, sildenafil (for erectile dysfunction), sirolimus, statins (atorvastatin, fluvastatin, pravastatin, rosuvastatin), tacrolimus, tadalafil (for erectile dysfunction), trazodone, vardenafil (for erectile dysfunction), verapamil, warfarin and some medicines used to treat HIV infections (e.g. atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir).

Proper Use of This Medication

  • Take VICTRELIS TRIPLE exactly as your healthcare provider tells you. Your healthcare provider will tell you how much to take and when to take it.
  • Tell your doctor, pharmacist or health professional if you notice any change in the appearance of boceprevir capsule, ribavirin capsule or peginterferon alfa-2b powder for solution.
  • Always take VICTRELIS and ribavirin with food.

The following instructions explain how to reconstitute and inject peginterferon alfa-2b powder for solution yourself. Please read the instructions carefully and follow them step by step. Your doctor or his/her assistant will instruct you how to self-inject peginterferon alfa-2b. Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.

Carefully follow the instructions provided.

How to Use the Peginterferon Alfa-2b Clearclick Single Dose Delivery System

Getting ready

  • Find a well-lit, clean flat work surface such as a table.
  • Take the pre-filled pen out of the refrigerator. Look at the date printed on the carton to make sure that the expiration date has not passed. Do not use if the expiration date has passed.
  • Remove the pre-filled pen from the carton.
  • Lay the pre-filled pen on a flat clean surface and wait a few minutes until it reaches room temperature.
  • Wash your hands well with soap and warm water. Keep your work area, your hands, and the injection site clean to decrease the risk of infection.

You will need the following supplies that are included in the package:

  • a PEGETRON CLEARCLICK pre-filled pen
  • a push-on needle
  • 2 alcohol swabs

  1. Mix
    • Hold the pre-filled pen upright with the dial on the bottom.
    • Turn dial to number 1 (see Figure 1). You may hear a "click" sound.

      Figure 1

    • DO NOT SHAKE TO MIX. Gently turn the pre-filled pen upside down two times to mix (see Figure 2).

      Figure 2

    • Look in the window. The solution should be clear and colourless before use. Do not use if it is discoloured or if particles are present.
  2. Add needle
    • Turn dial to number 2 (see Figure 3). You may hear a "click" sound.

      Figure 3

    • Wipe the pre-filled pen where needle attaches with alcohol swab (see Figure 4).

      Figure 4

    • Remove yellow paper from the needle cap before attaching to the pre-filled pen (see Figure 5).

      Figure 5

    • Support the pre-filled pen in upright position and push the needle straight down firmly (see Figure 6). You might hear a squishing sound.

      Figure 6

    • Remove needle cap. You may see some liquid trickle out of the needle (see Figure 7). This is normal.

      Figure 7

  3. Dial dose

    Turn the dial to your prescribed dose (see Figure 8). You may hear clicking sounds as you dial. Note: The needle shield will automatically SNAP UP as you dial (see Figure 9). You may dial up or down to any dose prior to injection.


    Figure 8


    Figure 9

You're ready to inject

  • Choose an injection site on your abdomen or thigh. Avoid your belly button (navel) and waistline. If you are very thin, you should only use the thigh for injection. You should use a different place each time you give yourself an injection. Do not inject into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
  • Wipe the injection site with alcohol swab. Let the skin air dry.
  • Pinch a fold of loose skin in the area you have cleaned for injection./li>
  • Press the pre-filled pen against skin as shown in Figure 10. The shield will glide back to allow needle to inject medication.
  • Hold the pre-filled pen against skin for 15 seconds. Note: 15 seconds is the maximum time required for any dose. The pre-filled pen will click for up to 10 seconds – depending on your dose.

Additional 5 seconds ensures complete dose delivery. Note: Once the pre-filled pen is removed from skin, the needle shield will lock in place.


Figure 10: Thigh injection

Disposal of the injection materials

The pre-filled pen, needle and all injection materials are intended for single use and must be discarded after the injection. Dispose of the used pre-filled pen safely in a closed container. Ask your doctor, hospital or pharmacist for an appropriate container.

Usual Adult Dose

Your doctor has determined the correct dose of ribavirin and peginterferon alfa-2b based on your weight and the regimen (plan of treatment) that you are following for hepatitis C. Boceprevir 800 mg Three Times Daily will be used in combination with peginterferon alpha and ribavirin. Boceprevir will only be added to the treatment from the start of the fifth week. The total duration of your treatment will depend on the way in which your virus responds to treatment.

Your doctor may adjust your dose and length of time you take this treatment according to your response. Blood tests will be done regularly to help your doctor to know if it is working and if the dose needs to be changed.

If you have or develop severe kidney or liver problems, this treatment will be stopped. This treatment is not recommended for use in patients under the age of 18 years.

Based on the results of a clinical trial, the recommended dose of peginterferon alfa-2b is 1.5 mcg/kg/week in combination with ribavirin, which are dosed by patient weight. Peginterferon alfa-2b should be administered as subcutaneous injection once a week.

Ribavirin capsules are taken daily. Ribavirin capsules are to be administered orally, 800–1,400 mg, each day in two divided doses with food (morning and evening).

Patients who Have Never Been Treated and Patients who Failed Prior Treatment

Recommended Dose

peginterferon alfa-2b: 1.5 mcg/kg/week ribavirin: 800–1,400 mg daily based upon patient weight boceprevir: 800 mg (four 200 mg capsules) three times daily (every 7 to 9 hours)

Dosing Recommendationsa

Patient
Weight
(kg)
peginterferon alfa-2b
Powder for Solution
ribavirin
Capsules
Weekly
Dose (mcg/kg)

CLEARCLICK
Size
(mcg/0.5 mL)b
Dail y
Dos e (mg)
Number of
Capsules
(200 mg)
40 to 501.5808002 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
51 to
65
1.51008002 x 200 mg capsules A.M.
2 x 200 mg capsules P.M.
66 to
80
1.51201,0002 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
81 to
105
1.51501,2003 x 200 mg capsules A.M.
3 x 200 mg capsules P.M.
> 1051.5c1,4003 x 200 mg capsules A.M.
4 x 200 mg capsules P.M.

a: The daily dose for ribavirin approximately falls within 13 ± 2 mg/kg/day.

b: When reconstituted as instructed

c: Should be calculated based on the body weight of an individual patient

It is important to follow your dosing schedule and your doctor's instructions on how to take your medications. Take the medicine for as long as prescribed and do not exceed the recommended dosage.

Always take boceprevir with food (a meal or a light snack, such as a piece of fruit or crackers).

Take the ribavirin capsules by mouth with water and during your meal. Do not chew the capsules.

Peginterferon alfa-2b is given at a dose of 1.5 mcg/kg once a week. Peginterferon alfa-2b is for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.

If you are injecting peginterferon alfa-2b yourself, please be sure that the dose that has been prescribed for you is clearly provided on the package of medicine you receive. Inject peginterferon alfa-2b on the same day each week. Injecting it at the same time of day each week will help you not to forget to take it. Take the dose as soon as you remember, then continue your treatment as usual. Do not take a double dose to make up for forgotten individual doses. Contact your doctor or pharmacist if needed.

Overdose

The primary effects of overdose were an increased incidence and severity of adverse events reported at the therapeutic doses of VICTRELIS TRIPLE.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose of boceprevir and it is less than 2 hours before the next dose is due, the missed dose should be skipped. If you miss a dose and it is more than 2 hours before the next dose is due, take the missed dose with food and continue the normal dosing schedule. Do not double the next dose. If you have questions about what to do, call your healthcare provider.

If you miss a dose of ribavirin, take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your doctor about what to do. Do not double the next dose.

If you miss a dose of peginterferon alfa-2b, take the missed dose as soon as possible during the same day or on the next day, and continue the dosing schedule provided to you by your doctor. If several days go by, check with your doctor about what to do. Do not double the next dose.

Side Effects and What to Do About Them

What are the possible side effects of VICTRELIS TRIPLEtherapy?

Like all medicines, VICTRELIS TRIPLE can have side effects. Although not all of these side effects may occur, they may need medical attention if they do occur.

VICTRELIS TRIPLE may cause serious side effects, including:

  • Blood problems. VICTRELIS TRIPLE can cause low red cell counts (anemia) or low neutrophil (neutropenia), which is a type of white blood cell, and low platelet counts (thrombocytopenia). In some people, these blood counts may fall to dangerously low levels.
  • Allergic reaction: Serious allergic reactions can happen and may become severe requiring treatment in a hospital. Tell your doctor right away if you have any of these symptoms of an allergic reaction (itching, hives, trouble breathing or swallowing, or swelling of the face, eyes, lips, tongue or throat)

Check with your doctor immediately if any of the following side effects occur during treatment:

  • chest pain or persistent cough;
  • symptoms associated with a cold or other respiratory infection, such as difficulty breathing or cough;
  • shortness of breath;
  • fever or chills beginning after a few weeks of treatment;
  • changes in the way your heart beats;
  • feeling depressed or hopeless, or thinking about death (suicidal thoughts or attempts);
  • confusion, aggressiveness (sometimes directed against others), hallucination;
  • trouble sleeping;
  • severe stomach pain, black or tar-like stools, blood in stool or urine, feelings of numbness or tingling;
  • severe bleeding from your nose;
  • lower back or side pain, painful or difficult urination;
  • problems with your eyesight or hearing;
  • you notice that you are unusually tired and pale, and bruise easily.

Other events that may occur with this treatment are:

  • irritation or pain at the site of injection;
  • general discomfort, such as headache, fatigue or sleepiness, chills, fever, "flu-like" symptoms, weakness, pain around the ribs on the right side, feeling generally unwell, flushing, increased sweating;
  • high or low blood pressure;
  • dizziness, vertigo or faintness;
  • sore tongue or mouth, dry mouth, thirst, loss of appetite, weight loss, nausea (feeling sick), vomiting, stomach or abdominal pain, indigestion, gas, diarrhea, loose stools, constipation;
  • muscle ache, pain or stiffness, joint pain, arthritis;
  • irritability, anxiety, agitation, nervousness, mood swings, difficulty concentrating, lack of interest in life;
  • loss of hair or change in hair;
  • skin disorders, including itching or rash, dry skin, redness, brown spots on skin, increased or decreased sensitivity to touch, sensitivity to light, eczema, psoriasis;
  • disorders of the respiratory tract, including hoarseness, sore throat, cough, runny nose, stuffy nose, sinus infection, bronchitis, pneumonia;
  • viral or fungal infection, herpes simplex (fever blister); or
  • menstrual disorder.

The most common side effects of VICTRELIS TRIPLE include:

  • fatigue, low red blood cell count (anemia), change in sense of taste, nausea, headache, diarrhea, vomiting, abdominal pain, fever, muscle and joint pain, weight loss, difficulty in sleeping, and dry skin;
  • dizziness, fainting, changes in blood pressure, and blurred vision can occur, so be cautious before driving or operating heavy machinery.

Some patients may have: change in sense of taste or smell, inflammation, infection, pain, or dryness of the eye, tear disorder, blurred vision, earache, middle ear infection, allergic reaction, puffiness of hands and feet, inflamed or bleeding gums, tooth abscess, rectal sores, decreased sex drive, impotence, irritation of the vagina, migraine headache, gout, change in thyroid function.

Cases of stroke (cerebrovascular events) have been reported.

Peginterferon alfa-2b, alone or with ribavirin, may cause aplastic anemia. Aplastic anemia is a condition caused by the failure of the bone marrow to make new red blood cells, white blood cells and platelets. Pure red cell aplasia has also been reported. Pure red cell aplasia is a condition in which severe and sudden anemia (characterized by symptoms such as severe tiredness/fatigue, and shortness of breath on mild exertion) develops due to failure of the bone marrow to produce red blood cells.

Additionally, the following events have been reported with peginterferon alfa-2b: facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of circumscribed swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin) and blindness.

Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with peginterferonalfa-2b use.

The following additional side effects have been reported in general use with VICTRELIS TRIPLE: hives; mouth ulcers, sore mouth; serious skin reactions, including blistering or peeling of the skin, infection of the blood; pneumonia.

Tell your provider right away if you have any side effect that bothers you or that does not go away.

Serious Side Effects how Often They Happen and What to Do About Them

Symptom/effectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor
or pharmacist
Only
if
severe
In all
cases
Very
common
Blood problems: low
red cell counts (anemia)
which may lead to
tiredness, headaches,
shortness of breath
when exercising,
dizziness and looking
pale.
Blood problems: low
white blood cell counts
(neutropenia) which
may lead to an increased
risk of getting
infections.
CommonMental health:
depression, thoughts of
suicide, experience
hallucinations,
aggressiveness or
confusion, or have
trouble sleeping or
concentrating
Heart: chest pain, high
or low blood pressure,
changes in the way your
heart beats
Infection: High fever or
chills, or pain while
urinating
Thyroid: new or
worsening problems
with thyroid function
UncommonBlood sugar: high blood
sugar or diabetes
Colitis (inflammation of
the bowel): abdominal
pain, bloody diarrhea,
fever
Eye: change in vision
such as decrease or loss
of vision
Ear: hearing problem
Lung: trouble breathing,
infection, pneumonia,
inflammation of lung
tissue, new or worse
high blood pressure in
the lung (pulmonary
hypertension)
New or worsening
rheumatoid arthritis,
systemic lupus
erythematosus, psoriasis
Women who are
planning or become
pregnant
 Serious allergic reaction
with symptoms such as
hives, itching, trouble
breathing or
swallowing, swelling of
the lips, mouth or throat.
 Serious skin reactions
such as blistering or
peeling of the skin.

This is not a complete list of side effects. For any unexpected effects while taking VICTRELIS TRIPLE, contact your doctor or pharmacist.

How to Store It

Storage of VICTRELIS TRIPLE Packages:

Store the VICTRELIS TRIPLE package refrigerated between 2°C and 8°C.

Storage of boceprevir:

Boceprevir Capsules should be refrigerated at 2°C–8°C until dispensed by a pharmacist. When separated and for patient use, refrigerated capsules of VICTRELIS can remain stable until the expiration date printed on the label. VICTRELIS can also be stored at room temperature (15°C–30°C) for 3 months. Store in the original container.

Storage of ribavirin:

When separated, ribavirin capsules should be stored in the refrigerator between 2°C and 8°C or at controlled room temperature between 15°C and 30°C.

Keep VICTRELIS TRIPLE and all medicines out of the reach and sight of children.

Do not use past expiry date on the label.

Stability and storage for peginterferon alfa-2b CLEARCLICK:

Store the PEGETRON CLEARCLICK at 2°C to 8°C. Once reconstituted PEGETRON CLEARCLICK should be used immediately but may be stored at 2°C - 8°C for up to 24 hours. Do not freeze.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, ON K1A 0K9

      Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect

or at Merck Canada Inc. by one of the following 2 ways:

  • Call toll-free at 1-800-567-2594
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-877-428-8675, or
    • Mail to: Merck Canada Inc.
      16750, route Transcanadienne
      Kirkland, Québec H9H 4M7

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program or Merck do not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.merck.ca or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.