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

Manufacture: Merck and Co., Inc.
Country: Canada
Condition: Chronic Hepatitis C (Hepatitis C)
Class: Antiviral agents, Biologicals
Form: Subcutaneous (SC), Capsules, Powder
Ingredients: peginterferon alfa-2b, ribavirin, lactose

ribavirin plus peginterferon alfa-2b

About this Medication

What the Medication is Used For

  • Adult patients with chronic hepatitis C who have either not received previous treatment or who failed prior treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy.

Patients with the following characteristics are more likely to benefit from retreatment: previous relapse, previously treated with interferon therapy (non-pegylated), lower fibrosis score, lower baseline viral load, or infection with HCV genotype 2 or 3.

Patients with the following characteristics are less likely to benefit from retreatment: previous non-response, previously treated with pegylated interferon therapy, significant bridging fibrosis or cirrhosis, or infection with HCV genotype 1 infection.

Hepatitis C is a viral disease that causes inflammation of the liver. It develops into a chronic continuing condition in a great majority of patients. Patients with chronic hepatitis C may develop cirrhosis, liver cancer, or possibly even liver failure. Liver failure due to hepatitis C is currently the leading cause of liver transplants in Canada. PEGETRON may reduce hepatitis C virus in your blood stream to levels that cannot be measured by laboratory tests. However, it is not yet proven if it will cure your disease or prevent the complications associated with infection.

What it Does

PEGETRON therapy consists of two active medications, PEGETRON (ribavirin) Capsules and PEGETRON (peginterferon alfa-2b) Powder for Solution. PEGETRON (ribavirin) Capsules 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 the combined products work together to fight the hepatitis C infection.

PEGETRON 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.

It is not yet known if PEGETRON therapy will cure hepatitis C or prevent cirrhosis, liver failure, or liver cancer that can result from being infected with the hepatitis C virus.

It is also unknown if PEGETRON therapy will prevent one infected person from infecting another person with hepatitis C.

When it Should not be Used

Do not use these medicines:

  • 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. PEGETRON therapy can cause serious 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 PEGETRON (ribavirin) Capsules or PEGETRON (peginterferon alfa-2b) Powder for Solution or to any alpha interferon. Please see labels.
  • 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).
  • If you have severe kidney disease. If you are breastfeeding.

What the Medicinal Ingredients Are

  • peginterferon alfa-2b Powder for Solution and
  • ribavirin Capsules

What the Important Non-Medicinal Ingredients Are

Each PEGETRON (ribavirin) Capsules contain a small amount of lactose.

For a full listing of non -medicinal ingredients see Part 1 of the product monograph or labels.

What dosage forms it comes in

PEGETRON (ribavirin) Capsules plus PEGETRON (peginterferon alfa-2b) Powder for Solution in Vials Each PEGETRON Capsule contains 200 mg of ribavirin.

PEGETRON Powder for Solution is supplied as a powder of peginterferon alfa-2b at strengths of 50 and 150 mcg for single use. Before reconstitution, PEGETRON Powder for Solution may appear either as a white, tablet-shaped solid that is whole or in pieces, or as a white powder. The powder is contained in a 2 mL vial.

PEGETRON (ribavirin) Capsules plus PEGETRON (peginterferon alfa-2b) Powder for Solution in CLEARCLICK Single Dose Delivery Systems. Each PEGETRON Capsule contains 200 mg of ribavirin.

PEGETRON (peginterferon alfa-2b) CLEARCLICK Single Dose Delivery Systems consist of a dual-chamber glass cartridge with a chamber containing PEGETRON as a white to off-white 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. They are 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 PEGETRON (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.

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

  1. PEGETRON Therapy could seriously harm your unborn child.
    • If you or your partner are pregnant, you should not receive PEGETRON (ribavirin) Capsules and PEGETRON (peginterferon alfa-2b) Powder for Solution.
    • 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.
    • 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. You should discuss with your doctor how you or your partner can prevent getting pregnant.
  2. PEGETRON (ribavirin) Capsules cause anemia, which is a decrease in the number of red blood cells you have. This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your doctor before taking PEGETRON therapy if you have or have ever had any cardiovascular problems.

What Should I Avoid While Taking Pegetron Therapy

  • You or your partner should avoid becoming pregnant while taking PEGETRON therapy and for 6 months after stopping therapy. PEGETRON therapy can cause serious birth defects or harm to your unborn child or difficulty with pregnancy. Thus, you must use effective contraception during this time. If you or your partner become pregnant during treatment or during the 6 months after treatment, you should immediately report the pregnancy to your doctor. Your doctor should call Merck Canada Inc., Medical Information Department at 1-800-463-5442.
  • You should not inject yourself with any medicine that appears discolored or irregular. Tell your doctor, pharmacist or health professional if you notice any change in the appearance of the PEGETRON (ribavirin) Capsules or PEGETRON (peginterferon alfa-2b) Powder for Solution.
  • Tell your doctor about any other medications you are taking.
  • Ask your doctor if there are other things you should avoid.
  • 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 PEGETRON 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, because therapy may cause heart problems to become worse.
    • Blood disorders; including anemia (low red blood cell count), thalassemia (Mediterranean anemia), and sickle-cell anemia, because therapy may further reduce the number of red 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 PEGETRON.
    • Be sure to tell your doctor if you are taking the Chinese herbal medication Shosaikoto (also known as Xiao-Chai-Hu-Tang).
    • If you have a history of substance abuse (e.g., alcohol or drugs).

    Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving PEGETRON. In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with PEGETRON. 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.

    Interactions With This Medication

    Drugs that may interact with PEGETRON 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 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.

    Proper Use of This Medication

    The following instructions explain how to reconstitute and inject PEGETRON (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 PEGETRON (peginterferon alfa-2b) Powder for Solution. Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.

    If you are using PEGETRON in Vials, see the PEGETRON Powder for Solution in Vials section.

    If you are using PEGETRON CLEARCLICK, see the PEGETRON CLEARCLICK Single Dose Delivery System section.

    Carefully follow the instructions provided.

    Pegetron Powder for Solution in Vials

    Each vial must be reconstituted with 0.7 mL of diluent (Sterile Water for Injection) and up to 0.5 mL of solution will be administered. A small volume is lost during preparation of PEGETRON (peginterferon alfa-2b) solution when the dose is measured and injected. Thus, each unit contains an excess amount of diluent and PEGETRON (peginterferon alfa-2b) Powder for Solution to ensure delivery of the labeled dose in 0.5 mL of PEGETRON (peginterferon alfa-2b) Injection. The labeled strength will be contained in 0.5 mL of the reconstituted solution. The reconstituted solution for each of the available strengths will have a concentration of 50 mcg/0.5 mL or 150 mcg/0.5 mL.

    Preparing PEGETRON Powder for Solution

    1. Find a comfortable, well-lit place and assemble supplies (vial, diluent, syringe, alcohol swabs and disposal container).
    2. The supplies you will need are provided in the PEGETRON package; you should place them on a clean work area. The PEGETRON package contains 2 vials of PEGETRON Powder for Solution, 2 vials of Sterile Water for Injection (1 mL/vial) (DILUENT), 4 disposable syringes, and 4 alcohol swabs. These syringes have a needle already attached that cannot be removed and are for single use only.
    3. Check the date printed on the PEGETRON carton to make sure that the expiration date has not passed.
    4. Wash your hands thoroughly with soap and water, rinse and dry with a clean towel.
    5. Remove the protective wrapper from ONE of the syringes provided and use for the following steps.
    6. Remove the protective plastic cap from the top of both the supplied diluent (Sterile Water for Injection) and the PEGETRON Powder for Solution vials, leaving the rubber stopper and aluminum ring in place.
    7. Clean the rubber stopper on the top of each vial with an alcohol swab (Figure A).
    8. Remove the protective cap from the needle by pulling the cap straight off, and fill the syringe with air by pulling the plunger to 0.7 mL mark (Figure B).
    9. Hold the DILUENT vial upright. Do not touch the cleaned top of the vial with your hands (Figure C).
    10. With vial on flat surface, insert the needle through the rubber stopper of the diluent vial, and inject the air in the syringe into the vial (Figure D).
    11. With needle in vial, turn the vial upside down in one hand. Your other hand will be free to move the plunger. Make sure the tip of the needle is in the liquid.
    12. Withdraw only 0.7 mL of diluent by pulling the plunger back to exactly 0.7 mL mark (Figure E). The marks on the side of the syringe indicate the amount of DILUENT withdrawn.
    13. Remove the needle from the vial (Figure F). Discard the remaining diluent.
    14. To prepare the PEGETRON Powder for Solution, insert the needle through the rubber stopper of the PEGETRON vial, and gently place the needle tip against the glass wall of the vial (Figure G).
    15. Slowly inject 0.7 mL of diluent into the vial of PEGETRON aiming the stream of liquid at the glass wall of the vial. It is best not to aim the stream directly at the white solid or powder, or to inject the liquid quickly, as this causes a greater amount of bubbles.
    16. Remove the needle from the vial. Grasp sleeve firmly and twist flanges to loosen the sleeve. Fully retract needle into sleeve until it locks in the protected position. When the BD Safety-Lok* Syringe safety lock indicator green band fully covers the red band and an audible click is heard, the sleeve is locked into position
    17. Place empty syringe with needle in disposal container. Check with your nurse or pharmacist for proper disposal. The diluent vial, syringe protective cap and used alcohol swab are intended for single use and must be discarded. A new syringe will be used for injection of the medication.
    18. The solution may appear cloudy or bubbly for a few minutes. To complete the dissolution of the powder, gently swirl the vial of PEGETRON with a circular motion (Figure H). Do not shake, but gently turn the vial upside down. The contents should now be completely dissolved.
    19. Once the solution has settled, wait for all the bubbles to rise to the top of the solution. You should have a clear solution with a small ring of tiny bubbles around the top.
    20. When the PEGETRON powder is completely dissolved, it will be clear, colorless and without particles. Visually inspect the reconstituted solution prior to administration: do not use it if you see particles or the solution is not colorless; call your doctor, nurse, or pharmacist.
    21. The solution will be ready for injection once it has reached room temperature (about 10 minutes). Since the product contains no preservatives or antimicrobials, it is best to withdraw the appropriate dose from the vial as soon as the solution is ready.
    22. Filling the Syringe with PEGETRON

    23. After the PEGETRON powder is completely dissolved, clean the vial’s rubber stopper with an alcohol swab again.
    24. Take another syringe provided and unwrap it. You will use it to give yourself the injection.
    25. Remove the protective cap from the needle and fill the syringe with air by pulling the plunger to the number (mL) that corresponds to your prescribed dose (Figure I).
    26. Hold the PEGETRON vial upright. Do not touch the cleaned top of the vial with your hands (Figure J). With the vial on a flat surface, push the needle through the rubber stopper of PEGETRON vial and inject the air into the vial (Figure K).
    27. With the needle in the vial, turn the PEGETRON vial and the syringe upside down in one hand. Your other hand will be free to move plunger.
    28. Be sure the tip of needle is in the PEGETRON solution.
    29. While holding the vial and syringe with one hand, slowly pull the plunger back to withdraw into the syringe very slightly more than the dose of PEGETRON your doctor told you to use (Figure L). The marks on the side of the syringe indicate the amount of PEGETRON withdrawn.
    30. Remove the needle from the vial (Figure M) and hold the syringe with the needle pointing upwards. Do not touch the needle. Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back and gently tap the syringe, with the needle pointing upwards, until bubbles disappear (Figure N). Then, push the plunger slowly back up to the correct dose.
    31. Replace the cover on the needle and put the syringe on a clean flat surface. Discard any unused solution.
    32. The solution should be at room temperature up to 25°C (77 °F). If the solution is cold, warm the syringe between your palms. You are now ready to inject the dose.
    33. Injecting the Pegetron Dose

    34. Select an injection site.
      • The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh outer surface of you upper arm (you may need the assistance o another person to use this site), and abdomen (Figure O). Do not inject yourself in the area near your navel or waistline. If you are very thin, you should only use the thigh or outer surface of the arm for injection.

        Do not inject in area that is red or sore.


        Change your injection site each time. Use the same site only once every six or seven weeks.

    35. Clean and disinfect the skin where the injection is to be given with an alcohol swab using a circular motion (approximately for 10 seconds) (Figure P). Allow area to dry.
    36. Remove the protective cap from the needle.
    37. Hold the syringe between thumb and forefinger, like holding a pencil.
    38. With the other hand, grab the skin where the injection will be made. Pinch a 5-cm (2 inches) fold of loose skin.
    39. Hold the needle at a 45 to 90 degree angle to the skin about 5 cm (2 inches) above the skin surface, insert the needle into the pinched skin with a quick jab as if throwing a dart. The entire needle or at least ¾ of it should go into the skin (Figure Q).
    40. After the needle is in, remove the hand that you used to pinch your skin and use it to hold the syringe barrel.
    41. Inject the medicine by slowly pushing the plunger all the way down the syringe barrel (Figure R).
    42. After injecting solution, pull the needle straight out of the skin.
    43. Press the injection site with a small bandage or sterile gauze if necessary for several seconds (Figure S). Do not massage the injection site.
    44. If there is bleeding, cover with an adhesive bandage.
    45. Cleaning up

    46. Grasp sleeve firmly and twist flanges to loosen the sleeve. Fully retract needle into sleeve until it locks in the protected position. When the BD Safety-Lok Syringe safety lock indicator green band fully covers the red band and an audible click is heard, the sleeve is locked into position.
    47. Place the empty syringe with the needle in the disposal bottle. Check with your nurse or pharmacist for proper disposal. The vials and injection materials are intended for single use and must be discarded. Do not leave used supplies or the disposal bottle for syringes in an open area.

    Pegetron (peginterferon alfa-2b) Clearclick Single Dose Delivery System

    How to use the Pegetron Clearclick

    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

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

    Add Needle

    • Turn dial to number 2 (see Figure 3). You may hear a “click” sound.
    • Wipe the pre-filled pen where needle attaches with alcohol swab (see Figure 4).
  • Remove yellow paper from the needle cap before attaching to the pre-filled pen (see 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.
  • Remove needle cap. You may see some liquid trickle out of the needle (see Figure 7). This is normal.
  • 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.

    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.
    • 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.

    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 Dose

    Your doctor has determined the correct dose of PEGETRON (ribavirin) Capsules and PEGETRON (peginterferon alfa-2b) Powder for Solution based on your weight and the regimen (plan of treatment) that you are following for hepatitis C.

    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. At the end of the first 24 weeks of treatment, your doctor will decide whether the treatment will be continued for another 24 weeks (total of 48 weeks). Most patients are treated for 48 weeks.

    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 the clinical trial, the recommended dose of PEGETRON (peginterferon alfa-2b) Powder for Solution is 1.5 mcg/kg/week in combination with PEGETRON (ribavirin) Capsules, which are dosed by patient weight. PEGETRON (peginterferon alfa-2b) Powder for Solution should be administered as subcutaneous injection once a week. PEGETRON (ribavirin) Capsules are taken daily. PEGETRON 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 - HCV Genotype 1 - Recommended Dose

    PEGETRON (peginterferon alfa-2b) Powder for Solution: 1.5 mcg/kg/week PEGETRON (ribavirin) Capsules: 800 - 1,400 mg daily based upon patient weight

    Dosing Recommendations
    Patient
    Weight
    (kg)
    peginterferon alfa-2b Powder for Solutionribavirin Capsules
    Weekly
    Dose
    (mcg/kg)
    Vial or
    CLEARCLICK
    Size
    (mcg/0.5 mL)
    Daily
    Dose
    (mg)
    Number of Capsules (200 mg)
    <401.5508002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    40 to 501.5808002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    51 to 651.51008002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    66 to 801.51201,0002 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.
    81 to 1051.51501,2003 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.
    > 1051.5*1,4003 x 200 mg capsules A.M.
    4 x 200 mg capsules P.M.

    : The daily dose for PEGETRON (ribavirin) Capsules approximately falls within 13 ± 2 mg/kg/day.
    1: When reconstituted as instructed
    *: Should be calculated based on the body weight of an individual patient
    ¥: PEGETRON (peginterferon alfa-2b) Powder for Solution in vials is available in the following strengths: 50 mcg/0.5 mL & 150 mcg/0.5 mL. PEGETRON (peginterferon alfa-2b) Powder for Solution in CLEARCLICK delivery system is not available in the 50 mcg/0.5 mL strength.

    PATIENTS WHO HAVE NEVER BEEN TREATED - HCV non-Genotype 1 - Recommended Dose

    PEGETRON (peginterferon alfa-2b) Powder for Solution: 1.5 mcg/kg/week

    PEGETRON (ribavirin) Capsules: 800 - 1,200 mg daily based upon patient weight

    Dosing Recommendations
    Patient
    Weight
    (kg)
    peginterferon alfa-2b Powder for Solutionribavirin Capsules
    Weekly
    Dose
    (mcg/kg)
    Vial or
    CLEARCLICK
    Size
    (mcg/0.5 mL)
    Daily
    Dose
    (mg)
    Number of Capsules (200 mg)
    < 401.5508002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    40 to 501.5808002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    51 to 651.51008002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    66 to 851.51201,0002 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.
    > 851.51501,2003 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.

    : The daily dose for PEGETRON (ribavirin) Capsules approximately falls within 13 ± 2 mg/kg/day.
    1: When reconstituted as instructed
    *: Should be calculated based on the body weight of an individual patient
    ¥: PEGETRON (peginterferon alfa-2b) Powder for Solution in vials is available in the following strengths: 50 mcg/0.5 mL & 150 mcg/0.5 mL. PEGETRON (peginterferon alfa-2b) Powder for Solution in CLEARCLICK delivery system is not available in the 50 mcg/0.5 mL strength.

    PATIENTS WHO FAILED PRIOR TREATMENT - Any HCV Genotypes - Recommended Dose

    PEGETRON (peginterferon alfa-2b) Powder for Solution: 1.5 mcg/kg/week

    PEGETRON (ribavirin) Capsules: 800 - 1,400 mg daily based upon patient weight

    Dosing Recommendations
    Patient
    Weight
    (kg)
    peginterferon fa-2b Powder for Solutionribavirin Capsules
    Weekly
    Dose
    (mcg/kg)
    Vial or
    CLEARCLICK
    Size
    (mcg/0.5 mL)
    Daily
    Dose
    (mg)
    Number of Capsules (200 mg)
    < 401.5508002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    40 to 501.5808002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    51 to 651.51008002 x 200 mg capsules A.M.
    2 x 200 mg capsules P.M.
    66 to 851.51201,0002 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.
    86 to 1051.51501,2003 x 200 mg capsules A.M.
    3 x 200 mg capsules P.M.
    > 1051.5*1,4003 x 200 mg capsules A.M.
    4 x 200 mg capsules P.M.

    : The daily dose for PEGETRON (ribavirin) Capsules approximately falls within 13 ± 2 mg/kg/day.
    1: When reconstituted as instructed
    *: Should be calculated based on the body weight of an individual patient
    ¥: PEGETRON (peginterferon alfa-2b) Powder for Solution in vials is available in the following strengths: 50 mcg/0.5 mL & 150 mcg/0.5 mL. PEGETRON (peginterferon alfa-2b) Powder for Solution in CLEARCLICK™ delivery system is not available in the 50 mcg/0.5 mL strength.

    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.

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

    PEGETRON (peginterferon alfa-2b) Powder for Solution is given at a dose of 1.5 mcg/kg once a week. PEGETRON (peginterferon alfa-2b) Powder for Solution 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 PEGETRON (peginterferon alfa-2b) Powder for Solution yourself, please be sure that the dose that has been prescribed for you is clearly provided on the package of medicine you receive. Inject PEGETRON (peginterferon alfa-2b) Powder for Solution 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 PEGETRON.

    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 PEGETRON (ribavirin) Capsules, 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 PEGETRON (peginterferon alfa-2b) Powder for Solution, 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 PEGETRON Therapy

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

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

    • chest pain or persistent cough;
    • symptoms of a severe allergic reaction (such as difficulty breathing, wheezing, or hives);
    • 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.

    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.

    Very rarely, cases of stroke (cerebrovascular events) have been reported.

    Very rarely, PEGETRON (peginterferon alfa-2b) Powder for Solution, 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 PEGETRON (peginterferon alfa-2b) Powder for Solution: 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

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

    Symptom/effectTalk with your doctor or pharmacistStop taking
    drug and
    call your
    doctor or
    pharmacist
    Only if
    severe
    In all
    cases
    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
    Blood: lower blood cells that may lead to bleeding, anemia
    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

    PEGETRON (peginterferon alfa-2b) Powder for Solution use.

    If you notice any side effects not mentioned in this patient information, please inform your doctor or pharmacist.

    How to Store It

    Storage of Pegetron Packages

    Store the PEGETRON (ribavirin) Capsules plus PEGETRON (peginterferon alfa-2b) Powder for Solution package refrigerated between 2°C and 8°C (36°F and 46°F).

    Storage of Pegetron (ribavirin) Capsules

    When separated, PEGETRON (ribavirin) Capsules should be stored in the refrigerator between 2°C and 8°C (36°F and 46°F) or at controlled room temperature between 15°C and 30°C (59°F and 86°F).

    Storage of Pegetron (peginterferon alfa-2b) Powder for Solution in Vials

    When separated and before reconstitution, the individual carton of PEGETRON (peginterferon alfa-2b) Powder for Solution should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). After reconstitution with Sterile Water for Injection, the reconstituted product is to be used immediately. Since no preservative is present, it is recommended that administration of the solution occurs as soon as possible and within 3 hours of reconstitution. For reconstitution under controlled and validated aseptic conditions such as a hospital pharmacy, the chemical and physical in-use stability of the reconstituted solution has been demonstrated 24 hours at 2°C - 8°C (36°F - 46°F).

    Discard any unused portion.

    Do not use past expiry date on the label.

    FROZEN STORAGE OF THE FILLED SYRINGES IS NOT RECOMMENDED.

    Reconstitution means adding a liquid (diluent) to a dry powder.

    Stability and storage for Pegetron Clearclick

    Store the PEGETRON CLEARCLICK at 2°C to 8°C (36°F to 46°F). Once reconstituted PEGETRON CLEARCLICK should be used immediately but may be stored at 2°C - 8°C (36°F - 46°F) for up to 24 hours. Do not freeze.

    Do not use past expiry date on the label.

    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, Ontario 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.

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

    More Information

    For this document plus the full product monograph, prepared for health professionals, please contact the sponsor, Merck Canada Inc. at 1-800-567-2594.