|
|
PegIntron®
(Peginterferon alfa-2b)
Including appendix with instructions for using PegIntron (peginterferon alfa-2b) ® Powder for Injection
Read this Medication Guide carefully before you start taking PegIntron (peginterferon alfa-2b) ® (Peg In-tron) or PegIntron (peginterferon alfa-2b) /REBETOL® (REB-eh-tole) combination therapy. Read the Medication Guide each time you refill your prescription because there may be new information. The information in this Medication Guide does not take the place of talking with your health care provider (doctor, nurse, nurse practitioner, or physician's assistant).
If you are taking PegIntron (peginterferon alfa-2b) /REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin USP) Capsules and Oral Solution.
What is the most important information I should know about PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
PegIntron (peginterferon alfa-2b) (peginterferon) is a treatment for some peoplewho are infectedwith hepatitis C virus. However, PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy can have serious side effects that may cause death in rare cases. Before you decide to start treatment, you should talk to your health care provider about the possible benefits and side effects of PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. If you begin treatment you will need to see your health care provider regularly for medical examinations and lab tests to make sure your treatment is working and to check for side effects.
REBETOL may cause birth defects and/or death of an unborn child. If you are pregnant, you or your male partner must not take PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. You must not become pregnant while either you or your partner are being treated with the combination PegIntron (peginterferon alfa-2b) /REBETOL therapy, or for 6months after stopping therapy. Men and women should use birth control while taking the combination therapy and for 6 months afterwards. If you or your partner are being treated and you become pregnant either during treatment or within 6 months of stopping treatment, call your health care provider right away. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your health care provider are encouraged to contact the Registry at 1-800-593-2214.
If you are taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy you should call your health care provider immediately if you develop any of these symptoms:
New or worsening mental health problems such as thoughts about killing or hurting yourself or others, trouble breathing, chest pain, severe stomach or lower back pain, bloody diarrhea or bloody bowel movements, high fever, bruising, bleeding, or decreased vision.
The most serious possible side effects of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapy include:
Problems with Pregnancy. Combination PegIntron (peginterferon alfa-2b) /REBETOL therapy can cause death, serious birth defects, or other harm to your unborn child. If you are a woman of childbearing age, you must not become pregnant during treatment and for 6 months after you have stopped therapy. You must have a negative pregnancy test immediately before beginning treatment, during treatment, and for 6months after you have stopped therapy. Both male and female patients must use effective forms of birth control during treatment and for the 6months after treatment is completed. Male patients should use a condom. If you are a female, you must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your health care provider about birth control for you and your partner.
Mental health problems and suicide. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapies may cause patients to develop mood or behavioral problems. These can include irritability (getting easily upset) and depression (feeling low, feeling bad about yourself, or feeling hopeless). Some patients may have aggressive behavior. Former drug addicts may fall back into drug addiction or overdose. Some patients think about hurting or killing themselves or other people and some have killed (suicide) or hurt themselves or others. You must tell your health care provider if you are being treated for a mental illness or had treatment treatment in the past for any mental illness, including depression and suicidal behavior. You should tell your health care provider if you have ever been addicted to drugs or alcohol.
Heart problems. Some patients taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks. Tell your health care provider if you have had any heart problems in the past.
Blood problems. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapies commonly lower two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously low levels. If your blood counts become very low, this could lead to infections or bleeding.
REBETOL therapy causes a decrease in the number of red blood cells you have (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your health care provider before taking combination PegIntron (peginterferon alfa-2b) /REBETOL therapy if you have or have ever had any cardiovascular problems.
Body organ problems. Certain symptoms like severe stomach pain may mean that your internal organs are being damaged. Cases of weakness, loss of coordination, and numbness due to stroke have been reported in patients taking PegIntron (peginterferon alfa-2b) , including patients with few or no reported risk factors for stroke.
For other possible side effects, see “What are the possible side effects PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?” in this Medication Guide.
What is PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
The PegIntron (peginterferon alfa-2b) product is a drug used to treat adults who have a lasting chronic) infection with hepatitis C virus and who show signs that the virus is damaging the liver. PegIntron (peginterferon alfa-2b) /REBETOL combination therapy consists of two medications also used to treat hepatitis C infection in adults and children years of age and older. Patients with hepatitis C have the virus in their blood and in their liver. PegIntron (peginterferon alfa-2b) reduces the amount of virus in the body and helps the body's immune system fight the virus. REBETOL (ribavirin) is a drug that helps to fight the viral infection but does not work when used by itself to treat chronic hepatitis C.
It is not known if PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapies can cure hepatitis C (permanently eliminate the virus), or if it can prevent liver failure or liver cancer that is caused by hepatitis C infection.
It is also not known if PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy will prevent one infected person from infecting another person with hepatitis C.
Who should not take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy?
Do not take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy if you:
If you have any of the following conditions or serious medical problems, discuss them with your health care provider before taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy:
How should I take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL?
Your health care provider will decide whether you will take PegIntron (peginterferon alfa-2b) therapy alone or the combination of PegIntron (peginterferon alfa-2b) /REBETOL, as well as the correct dose (for adults the dose of PegIntron (peginterferon alfa-2b) is based on weight). For children 3 years of age and older, your health care provider will recommend the dose of PegIntron (peginterferon alfa-2b) based on body surface area. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL are given for up to 1 year. Take your prescribed dose of PegIntron (peginterferon alfa-2b) ONCE A WEEK, on the same day of each week and at approximately the same time. Take the medicine for the full course of prescribed therapy and do not take more than the prescribed dose. REBETOL should be taken with food. When you take REBETOL with food, more of the medicine (70% more on average) is taken up by your body. You should take REBETOL the same way every day (twice a day with food) to keep the medicine in your body at a steady level. This will help your health care provider to decide how your treatment is working and how to change the dose of REBETOL you take if you have side effects from REBETOL. Be sure to read the Medication Guide for REBETOL (ribavirin USP) for complete instructions on how to take the REBETOL Capsules and Oral Solution.
You should be completely comfortable with how to prepare PegIntron (peginterferon alfa-2b) , how to set the dose you take, and how to inject yourself before you use PegIntron (peginterferon alfa-2b) for the first time. PegIntron (peginterferon alfa-2b) comes in two different forms, a powder in a singleuse vial and a REDIPEN® single-use delivery system. See the attached appendix for detailed instructions for preparing and giving a dose of PegIntron (peginterferon alfa-2b) .
If you miss a dose of the PegIntron (peginterferon alfa-2b) product, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your health care provider about what to do. Do not double the next dose or take more than one dose a week without talking to your health care provider. Call your health care provider right away if you take more than your prescribed PegIntron (peginterferon alfa-2b) dose. Your health care provider may wish to examine you more closely, and take blood for testing.
If you miss a dose of REBETOL, take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your health care provider about what to do. Do not double the next dose.
You must get regular blood tests to help your health care provider check how the treatment is working and to check for side effects.
Tell your health care provider if you are taking or planning to take other prescription or non-prescription medicines, including vitamin and mineral supplements and herbalmedicines.
What should I avoid while taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapies?
What are the possible side effects of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
Possible serious side effects include:
Common but less serious side effects include:
These are not all of the side effects of PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. Your health care provider or pharmacist can give you a more complete list.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General advice about prescription medicines:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about PegIntron (peginterferon alfa-2b) , ask your health care provider. Your health care provider or pharmacist can give you information about PegIntron (peginterferon alfa-2b) that was written for health care professionals. Do not use PegIntron (peginterferon alfa-2b) for a condition for which it was not prescribed. Do not share this medication with other people.
If you are taking PegIntron (peginterferon alfa-2b) /REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin USP) Capsules and Oral Solution.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: December 2008
How do I prepare and inject the PegIntron (peginterferon alfa-2b) dose?
Before you inject PegIntron (peginterferon alfa-2b) , the powder must be mixed with 0.7mL of the supplied DILUENT for PegIntron (peginterferon alfa-2b) , Sterile Water for Injection (diluent). This product can also be administered by a parent or caretaker as instructed by your health care provider. You should carefully follow the directions given to you by your health care provider.
The vial of mixed PegIntron (peginterferon alfa-2b) should be used immediately. DO NOT prepare more than one vial at a time. If you don't use the vial of the prepared solution right away, it must be stored in a refrigerator and used within 24 hours.
Storing PegIntron (peginterferon alfa-2b)
PegIntron (peginterferon alfa-2b) Powder should be stored at room temperature (25°C, 77°F); avoid exposure to heat. After mixing, the PegIntron (peginterferon alfa-2b) solution should be used immediately but may be stored in the refrigerator up to 24 hours. The solution contains no preservatives. DO NOT FREEZE.
Preparing the PegIntron (peginterferon alfa-2b) solution:
1. Find a clean, well-lit, non-slip flat working surface and assemble all of the supplies you will need for an injection. All of the supplies you will need for an injection are in the PegIntron (peginterferon alfa-2b) Powder for Injection package. The package contains:
2. Check the date printed on the PegIntron (peginterferon alfa-2b) carton to make sure that the expiration date has not passed. Remove one vial and look at the contents. The PegIntron (peginterferon alfa-2b) in the vial should appear as a white to off-white tablet-like solid that is whole/in pieces or as a loose powder.
If you have already mixed the PegIntron (peginterferon alfa-2b) solution and it has been stored properly in the refrigerator, take it out of the refrigerator and allow the solution to come to room temperature.
3. Wash your hands thoroughly with soap and water, rinse and towel dry. It is important to keep your work area, your hands, and injection site clean to minimize the risk of infection.
The disposable syringes have needles that are already attached and cannot be removed. Each syringe has a clear plastic safety sleeve that is pulled over the needle for disposal after use. The safety sleeve should remain tight against the flange while using the syringe and moved over the needle only when ready for disposal. Figure A.
The syringes and needles are for single use only.
Figure A
 |
4. Remove the protective wrapper from ONE of the syringes provided and use for the following steps 5-7. Make sure that the syringe safety sleeve is sitting against the flange (see Figure A).
5. Remove the protective plastic cap from the tops of both the supplied DILUENT and the PegIntron (peginterferon alfa-2b) vials. Clean the rubber stopper on the top of both vials with an alcohol swab.
6. Carefully remove the protective cap straight off of the needle to avoid damaging the needle point. Fill the syringe with air by pulling the plunger to 0.7mL (Figure B). Hold the DILUENT vial upright. Do not touch the cleaned top of the vial with your hands (Figure C). Insert the needle through the center of the rubber stopper of the DILUENT vial, and inject the air from the syringe into the vial (Figure D). Turn the vial upside down and make sure the tip of the needle is in the liquid. Withdraw only 0.7 mL of DILUENT by pulling the plunger back to the 0.7mLmark on the side of the syringe (Figure E). Remove the needle from the vial (Figure F). Discard the remaining DILUENT.
 |
 |
 |
 |
 |
7. Insert the needle through the center of the rubber stopper of the PegIntron (peginterferon alfa-2b) vial, and place the needle tip against the glass wall of the vial (Figure G). SLOWLY inject the 0.7 mL DILUENT so that the stream of DILUENT runs down the side of the vial. To prevent bubbles from forming, DO NOT AIM THE STREAM of diluent directly on the tablet-like SOLID or POWDER in the bottom of the vial. Remove the needle from the vial.
Firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click. The green stripe on the safety sleeve will completely cover the red stripe on the needle. (See Figure O in the section: “Injecting the PegIntron (peginterferon alfa-2b) Dose.”) Discard the syringe and needle in the puncture-proof container.
8. GENTLY swirl the vial in a gentle circular motion (Figure H), until the PegIntron (peginterferon alfa-2b) is completely dissolved. DO NOT SHAKE the vial. If any powder remains undissolved in the vial, gently turn the vial upside down until all of the powder is dissolved. It is not unusual for the solution to appear cloudy or bubbly for a few minutes. If air bubbles do form, wait until the solution has settled and all bubbles have risen to the top before withdrawing your dose from the vial.
 |
 |
9. After the solution has settled and is completely dissolved it should be clear, colorless and without particles, but there may be a ring of foam or bubbles on the surface; this is normal. Do not use it if you see particles or the color is not correct.
10. After the PegIntron (peginterferon alfa-2b) powder is dissolved but before you withdraw your dose, clean the rubber stopper again with an alcohol swab.
11. Unwrap the second syringe provided. You will use it to give yourself the injection. Carefully remove the protective cap from the needle and fill the syringe with air by pulling the plunger to the number on the side of the syringe (mL) that corresponds to your prescribed dose (Figure J). Hold the PegIntron (peginterferon alfa-2b) vial upright. DO NOT touch the cleaned top of the vial with your hands (Figure K). Insert the needle into the vial containing the PegIntron (peginterferon alfa-2b) solution and inject the air into the center of the vial (Figure L).
 |
 |
 |
12. Turn the PegIntron (peginterferon alfa-2b) vial upside down. Be sure the tip of the needle is in the PegIntron (peginterferon alfa-2b) solution. While holding the vial and syringe with one hand slowly pull the plunger back to withdraw the exact amount of PegIntron (peginterferon alfa-2b) into the syringe your health care provider told you to use (Figure M).
 |
13. Remove the needle from the vial (Figure N) and check for air bubbles in the syringe. If you see any bubbles, hold the syringe with the needle pointing up and gently tap the syringe until the bubbles rise. Then push the plunger in slowly until the bubbles disappear.
 |
Injecting the PegIntron (peginterferon alfa-2b) Dose
Selecting the Site for Injection.
The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen. 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.
You should use a different site each time you inject PegIntron (peginterferon alfa-2b) to avoid soreness at any one site. Do not inject PegIntron (peginterferon alfa-2b) solution into an area where the skin is irritated, red, bruised, infected or has scars, stretch marks or lumps.
14. Clean the skin where the injection is to be given with an alcohol swab, and wait for the area to dry. Remove the protective cap from the needle. Make sure the safety sleeve of the syringe is pushed firmly against the syringe flange so that the needle is fully exposed (see Figure A).
15. With one hand, pinch a 2-inch fold of loose skin. With your other hand, pick up the syringe and hold it like a pencil. Position the bevel of the needle facing up and insert the needle approximately 1/4 inch into the pinched skin at approximately a 45- to 90-degree angle with a quick dart-like thrust. After the needle is in, remove the hand that you used to pinch your skin and use it to hold the syringe barrel. Pull the plunger of the syringe back very slightly. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject. Withdraw the needle and discard the syringe as outlined in step 17. Repeat the above steps with a new vial to prepare a new syringe and inject the medicine at a new
site. If no blood is present in the syringe, inject the medicine by gently pressing the plunger all the way down the syringe barrel.
16. Hold an alcohol swab near the needle and pull the needle straight out of the skin. Press the alcohol swab over the injection site for several seconds. Do not massage the injection site. If there is bleeding, cover it with a bandage.
17. After injecting your dose, firmly grasp the safety sleeve and pull it over the exposed needle until you hear a click, and the green stripe on the safety sleeve covers the red stripe on the needle (Figure O). Discard the syringe and needle in the Sharp's container supplied to you.
 |
18. After 2 hours, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it doesn't clear up in a few days, contact your health care provider or nurse.
How do I dispose of the used syringes and needles?
Discard used safety lock syringes and needles in a Sharp's container or other puncture-proof container like a coffee can. DO NOT USE glass or clear plastic containers. Your health care provider or nurse will tell you how to dispose of a full container. Always keep the container out of reach of children.
Manufactured by: Schering Corporation, a subsidiary of Schering-Plough Corporation, Kenilworth, NJ 07033USA., ©2001, 2008, Schering Corporation. All rights reserved., Rev. 1/09 27853560T
PegIntron (peginterferon alfa-2b) ®
REDIPEN®
Single-dose Delivery System
(Peginterferon alfa-2b)
Including appendix with instructions for using
PegIntron (peginterferon alfa-2b) ® REDIPEN® Single-dose Delivery System
Read this Medication Guide carefully before you start taking PegIntron (peginterferon alfa-2b) ® (Peg In-tron) or PegIntron (peginterferon alfa-2b) /REBETOL® (REB-eh-tole) combination therapy. Read the Medication Guide each time you refill your prescription because there may be new information. The information in this Medication Guide does not take the place of talking with your health care provider (doctor, nurse, nurse practitioner, or physician's assistant).
If you are taking PegIntron (peginterferon alfa-2b) /REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin USP) Capsules and Oral Solution.
What is the most important information I should know about PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
PegIntron (peginterferon alfa-2b) (peginterferon) is a treatment for some people who are infected with hepatitis C virus. However, PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy can have serious side effects that may cause death in rare cases. Before you decide to start treatment, you should talk to your health care provider about the possible benefits and side effects of PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. If you begin treatment you will need to see your health care provider regularly for medical examinations and lab tests to make sure your treatment is working and to check for side effects.
REBETOL may cause birth defects and/or death of an unborn child. If you are pregnant, you or your male partner must not take PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. You must not become pregnant while either you or your partner are being treated with the combination PegIntron (peginterferon alfa-2b) /REBETOL therapy, or for 6 months after stopping therapy. Men and women should use birth control while taking the combination therapy and for 6 months afterwards. If you or your partner are being treated and you become pregnant, either during treatment or within 6 months of stopping treatment, call your health care provider right away. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your health care provider are encouraged to contact the Registry at 1-800-593-2214.
If you are taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy you should call your health care provider immediately if you develop any of these symptoms:
New or worsening mental health problems such as thoughts about killing or hurting yourself or others, trouble breathing, chest pain, severe stomach or lower back pain, bloody diarrhea or bloody bowel movements, high fever, bruising, bleeding, or decreased vision.
The most serious possible side effects of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapy include:
Problems with Pregnancy. Combination PegIntron (peginterferon alfa-2b) /REBETOL therapy can cause death, serious birth defects, or other harm to your unborn child. If you are a woman of childbearing age, you must not become pregnant during treatment and for 6 months after you have stopped therapy. You must have a negative pregnancy test immediately before beginning treatment, during treatment, and for 6 months after you have stopped therapy. Both male and female patients must use effective forms of birth control during treatment and for the 6 months after treatment is completed. Male patients should use a condom. If you are a female, you must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your health care provider about birth control for you and your partner.
Mental health problems and suicide. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapies may cause patients to develop mood or behavioral problems. These can include irritability (getting easily upset) and depression (feeling low, feeling bad about yourself, or feeling hopeless). Some patients may have aggressive behavior. Former drug addicts may fall back into drug addiction or overdose. Some patients think about hurting or killing themselves or other people and some have killed (suicide) or hurt themselves or others. You must tell your health care provider if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. You should tell your health care provider if you have ever been addicted to drugs or alcohol.
Heart problems. Some patients taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks. Tell your health care provider if you have had any heart problems in the past.
Blood problems. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL therapies commonly lower two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously lowlevels. If your blood counts become very low, this could lead to infections or bleeding.
REBETOL therapy causes a decrease in the number of red blood cells you have (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your health care provider before taking combination PegIntron (peginterferon alfa-2b) /REBETOL therapy if you have or have ever had any cardiovascular problems.
Body organ problems. Certain symptoms like severe stomach pain may mean that your internal organs are being damaged. Cases of weakness, loss of coordination, and numbness due to stroke have been reported in patients taking PegIntron (peginterferon alfa-2b) , including patients with few or no reported risk factors for stroke.
For other possible side effects, see “What are the possible side effects of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?” in this Medication Guide.
What is PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
The PegIntron (peginterferon alfa-2b) product is a drug used to treat adults who have a lasting (chronic) infection with hepatitis C virus and who show signs that the virus is damaging the liver. PegIntron (peginterferon alfa-2b) /REBETOL combination therapy consists of two medications also used to treat hepatitis C infection in adults and children 3 years of age and older. Patients with hepatitis C have the virus in their blood and in their liver. PegIntron (peginterferon alfa-2b) reduces the amount of virus in the body and helps the body's immune system fight the virus. REBETOL (ribavirin) is a drug that helps to fight the viral infection, but does not work when used by itself to treat chronic hepatitis C.
It is not known if PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapies can cure hepatitis C (permanently eliminate the virus), or if it can prevent liver failure or liver cancer that is caused by hepatitis C infection.
It is also not known if PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy will prevent one infected person from infecting another person with hepatitis C.
Who should not take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy?
Do not take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy if you:
If you have any of the following conditions or serious medical problems, discuss them with your health care provider before taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapy:
How should I take PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL?
Your health care provider will decide whether you will take PegIntron (peginterferon alfa-2b) therapy alone or the combination of PegIntron (peginterferon alfa-2b) /REBETOL, as well as the correct dose (for adults the dose of PegIntron (peginterferon alfa-2b) is based on weight). For children 3 years of age and older, your health care provider will recommend the dose of PegIntron (peginterferon alfa-2b) based on body surface area. PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL are given for up to 1 year. Take your prescribed dose of PegIntron (peginterferon alfa-2b) ONCE A WEEK, on the same day of each week and at approximately the same time. Take the medicine for the full course of prescribed therapy and do not take more than the prescribed dose. REBETOL should be taken with food. When you take REBETOL with food, more of the medicine (70%more on average) is taken up by your body. You should take REBETOL the same way every day (twice a day with food) to keep the medicine in your body at a steady level. This will help your health care provider to decide how your treatment is working and how to change the dose of REBETOL you take if you have side effects from REBETOL. Be sure to read the Medication Guide for REBETOL (ribavirin USP) for complete instructions on how to take the REBETOL capsules and oral solution.
You should be completely comfortable with how to prepare PegIntron (peginterferon alfa-2b) , how to set the dose you take, and how to inject yourself before you use PegIntron (peginterferon alfa-2b) for the first time. PegIntron (peginterferon alfa-2b) comes in two different forms, a powder in a single-use vial and a REDIPEN® single-use delivery system. See the attached appendix for detailed instructions for preparing and giving a dose of PegIntron (peginterferon alfa-2b) .
If you miss a dose of the PegIntron (peginterferon alfa-2b) product, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your health care provider about what to do. Do not double the next dose or takemore than one dose a week without talking to your health care provider. Call your health care provider right away if you take more than
your prescribed PegIntron (peginterferon alfa-2b) dose. Your health care provider may wish to examine you more closely, and take blood for testing.
If you miss a dose of REBETOL, take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your health care provider about what to do. Do not double the next dose.
You must get regular blood tests to help your health care provider check how the treatment is working and to check for side effects.
Tell your health care provider if you are taking or planning to take other prescription or non-prescription medicines, including vitamin and mineral supplements and herbal medicines.
What should I avoid while taking PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL therapies?
What are the possible side effects of PegIntron (peginterferon alfa-2b) and PegIntron (peginterferon alfa-2b) /REBETOL combination therapy?
Possible serious side effects include:
Common but less serious side effects include:
These are not all of the side effects of PegIntron (peginterferon alfa-2b) or PegIntron (peginterferon alfa-2b) /REBETOL combination therapy. Your health care provider or pharmacist can give you a more complete list.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General advice about prescription medicines:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about PegIntron (peginterferon alfa-2b) , ask your health care provider. Your health care provider or pharmacist can give you information about PegIntron (peginterferon alfa-2b) that was written for health care professionals. Do not use PegIntron (peginterferon alfa-2b) for a condition for which it was not prescribed. Do not share this medication with other people.
If you are taking PegIntron (peginterferon alfa-2b) /REBETOL combination therapy, also read the Medication Guide for REBETOL (ribavirin USP) Capsules and Oral Solution.
This Medication Guide has been approved by the U.S. Food and Drug Administration., Revised: December 2008
How do I prepare and inject the PegIntron (peginterferon alfa-2b) REDIPEN dose?
The PegIntron (peginterferon alfa-2b) REDIPEN system is for a single use, by one person only, ONCE A WEEK. The REDIPEN must not be shared. Use only the injection needle provided in the packaging for the PegIntron (peginterferon alfa-2b) REDIPEN system. If you have problems with the REDIPEN system or the PegIntron (peginterferon alfa-2b) solution, you should contact your health care provider or pharmacist.
The following instructions explain how to prepare and inject yourself with the PegIntron (peginterferon alfa-2b) REDIPEN system. This product can also be administered by a parent or caretaker as instructed by your health care provider. Please read the instructions carefully and follow them step by step. Your health care provider will instruct you on how to self-inject with the PegIntron (peginterferon alfa-2b) REDIPEN. Do not attempt to inject yourself unless you are sure you understand the procedure and requirements for self-injection.
How to Use the PegIntron (peginterferon alfa-2b) ® REDIPEN®
Single-dose Delivery System.
 |
Storing PegIntron (peginterferon alfa-2b)
PegIntron (peginterferon alfa-2b) REDIPEN should be stored in the refrigerator at 2°-8°C (36°- 46°F); avoid exposure to heat. After mixing, the PegIntron (peginterferon alfa-2b) solution should be used immediately but may be stored in the refrigerator up to 24 hours at 2°-8°C (36°-46°F). The solution contains no preservatives. DO NOT FREEZE.
Preparation
1. Find a clean, well-lit, non-slip flat working surface and assemble all of the supplies you will need for an injection. All of the supplies you will need are in the PegIntron (peginterferon alfa-2b) REDIPEN package. The package contains:
2. Take the PegIntron (peginterferon alfa-2b) REDIPEN out of the refrigerator and allow the medicine to come to room temperature. Before removing the REDIPEN from the carton, check the expiration date printed on the PegIntron (peginterferon alfa-2b) REDIPEN carton to make sure that the expiration date has not passed. Do not use if the expiration date has passed.
3. After taking the PegIntron (peginterferon alfa-2b) REDIPEN out of the carton, look in the window of the REDIPEN and make sure the PegIntron (peginterferon alfa-2b) in the cartridge holder window is a white to off-white tablet that is whole, or in pieces, or powdered.
4. Wash your hands thoroughly with soap and water, rinse, and towel dry. It is important to keep your work area, your hands, and the injection site clean to minimize the risk of infection.
1. Mix the Drug
Key points:
Before you mix the PegIntron (peginterferon alfa-2b) , make sure it is at room temperature. It is important that you keep the PegIntron (peginterferon alfa-2b) REDIPEN UPRIGHT (dosing button down) as shown in Figure 1.
a. Hold the PegIntron (peginterferon alfa-2b) REDIPEN UPRIGHT (Figure 1a) in the dosing tray on a hard, flat, non-slip surface with the dosing button down. You may want to hold the REDIPEN using the grip.
b. Tomix the powder and the liquid, keep the REDIPEN upright in the dosing tray and press the top half of the REDIPEN downward toward the hard, flat, non-slip surface until you hear the click (Figure 1b). Once you've heard the click, you will notice in the window that both dark stoppers are now touching. The dosing button should be flush with the pen body.
Figure 1a
 |
Figure 1b
 |
c. Wait several seconds for the powder to completely dissolve.
d. Gently turn the PegIntron (peginterferon alfa-2b) REDIPEN upside down twice (Figure 2).
To avoid excessive foaming, DO NOT SHAKE.
Figure 2
 |
e. Keep the PegIntron (peginterferon alfa-2b) REDIPEN UPRIGHT, with the dosing button down. Then, look through the REDIPEN window to see that the mixed PegIntron (peginterferon alfa-2b) solution is completely dissolved. The solution should be clear and colorless before use. Before attaching the needle, it is normal to see some small bubbles in the REDIPEN window, near the top of the solution. Do not use the solution if it is discolored, or not clear, or if particulates are present.
f. Place the PegIntron (peginterferon alfa-2b) REDIPEN back into the dosing tray provided in the packaging (Figure 3). The dosing button will be on the bottom.
Figure 3
 |
2. Attach the Needle
a. Wipe the rubber membrane of the PegIntron (peginterferon alfa-2b) REDIPEN with one alcohol swab.
b. Remove the protective paper tab from the injection needle, but do NOT remove either the outer cap or the yellow inner cap from the injection needle. Keeping the PegIntron (peginterferon alfa-2b) REDIPEN UPRIGHT in the dosing tray, FIRMLY push the injection needle straight into the REDIPEN rubber membrane, and screw it firmly in place, in a clockwise direction (Figure 4). Remember to leave the needle caps in place when you attach the needle to the REDIPEN. Pushing the needle through the rubber membrane “primes” the needle and allows the extra liquid and air in the pen to be removed.
Figure 4
 |
NOTE: Some fluid will trickle out. This is normal. The dark stoppers move up and you will no longer see the fluid in the window once the needle is successfully primed.
3. Dialing the Dose
a. Remove the PegIntron (peginterferon alfa-2b) REDIPEN from the dosing tray (Figure 5a). Holding the PegIntron (peginterferon alfa-2b) REDIPEN firmly, pull the dosing button out as far as it will go. You will see a dark band. Do not push the dosing button in until you are ready to self-inject the PegIntron (peginterferon alfa-2b) dose.
Figure 5a
 |
b. Turn the dosing button until your prescribed dose is lined up with the dosing tab (Figure 5b). The dosing button will turn freely. If you have trouble dialing your dose, check to make sure the dosing button has been pulled out as far as it will go (Figure 5c).
Figure 5b
 |
Figure 5c
 |
c. Carefully lay the PegIntron (peginterferon alfa-2b) REDIPEN down on a hard, flat, non-slip surface. Do NOT remove either of the needle caps and do NOT push the dosing button in until you are ready to self-inject the PegIntron (peginterferon alfa-2b) dose.
4. Injecting the PegIntron (peginterferon alfa-2b) Dose
Choosing 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, the outer surface of your upper arm, and abdomen. 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.
You should use a different site each time you inject PegIntron (peginterferon alfa-2b) to avoid soreness at any one site. Do not inject PegIntron (peginterferon alfa-2b) into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
a. Clean the skin where the injection is to be given with the second alcohol swab provided, and wait for the area to dry.
b. Remove the outer cap from the needle (Figure 6a). There may be some liquid around the yellow inner needle cap (Figure 6b). This is normal.
Figure 6a
 |
Figure 6b
 |
c. Once the injection site is dry, remove the yellow inner needle cap (Figure 6c). You are now ready to inject
Figure 6c
 |
d. Hold the PegIntron (peginterferon alfa-2b) REDIPEN with your fingers wrapped around the pen body barrel and your thumb on the dosing button (Figure 7).
Figure 7
 |
e. Gently press the injection site with a small bandage or sterile gauze if necessary for a few seconds but do notmassage the injection site. If there is bleeding, cover with an adhesive bandage. DO NOT RECAP THE NEEDLE and DO NOT REUSE the REDIPEN.
How do I dispose of the REDIPEN?
Discard the REDIPEN and needle and any solution remaining in the REDIPEN in a Sharp's container or other puncture-resistant container like a metal coffee can. DO NOT use glass or clear plastic containers. Ask your health care provider how to dispose of a full container. Always keep the container out of reach of children.
After 2 hours, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it doesn't clear up in a few days, contact your health care provider.
Last reviewed on RxList: 7/10/2009
This monograph has been modified to include the generic and brand name in many instances.
Here is a collection of user reviews for the medication Peg-Intron sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.
Copyright © 2012 by WebMD, LLC.
RxList does not provide medical advice, diagnosis or treatment. See additional information.
Updated & New