Peginterferon alfa-2b

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Peginterferon alfa-2b


Generic Name: Peginterferon alfa-2b (peg-in-ter-FEER-on)
Brand Name: PEG-Intron

Peginterferon alfa-2b may cause or worsen fatal or life-threatening mental, immune system, heart, blood vessel, and infectious disorders. Contact your doctor immediately if worsening of signs or symptoms occur.

Peginterferon alfa-2b may be used in combination with another medicine called ribavirin. Ribavirin may cause birth defects or fetal death. Women who are using this combination or whose male partners are using this combination should avoid becoming pregnant. Ribavirin may also cause severe anemia, which may worsen heart disease. Ribavirin may also cause cancer.


Peginterferon alfa-2b is used for:

The treatment of chronic hepatitis C virus infection. Peginterferon alfa-2b is used alone or with other medicines.

Peginterferon alfa-2b is an interferon (immune system chemical). It works by reducing the amount of hepatitis C virus in the body and helping the body"s immune system fight the virus.

Do NOT use Peginterferon alfa-2b if:

  • you are allergic to any ingredient in Peginterferon alfa-2b or you have had an allergic reaction to similar medicines
  • you have hepatitis caused by your immune system attacking your liver (auto-immune hepatitis) or severely decreased liver function

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

Before using Peginterferon alfa-2b :

Some medical conditions may interact with Peginterferon alfa-2b . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a mental disorder, have ever considered suicide, or have sleeping problems
  • if you have a history of heart attack, other heart or blood vessel problems, or high blood pressure
  • if you have diabetes, colitis (inflammation of the bowels), lung or thyroid diseases, certain eye problems (eg, caused by diabetes or high blood pressure), inflammation of the pancreas, cancer, kidney problems, bleeding problems, or if you are addicted to alcohol or other substances
  • if you have liver problems, including chronic hepatitis B, you have a decreased ability to fight infection including HIV infection, or you have had an organ transplant
  • if you have an autoimmune disorder (eg, lupus, rheumatoid arthritis, psoriasis)

Some MEDICINES MAY INTERACT with Peginterferon alfa-2b . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Fluorouracil or methadone because the risk of side effects may be increased
  • Flecainide, phenytoin, or warfarin because their effectiveness may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Peginterferon alfa-2b may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Peginterferon alfa-2b :

Use Peginterferon alfa-2b as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Peginterferon alfa-2b comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Peginterferon alfa-2b refilled.
  • Drink plenty of fluids while you are taking Peginterferon alfa-2b .
  • Take your prescribed dose of Peginterferon alfa-2b once a week, on the same day of each week, and at approximately the same time. Flu-like side effects (headache; tiredness; muscle aches; fever) of Peginterferon alfa-2b can be minimized by using the medicine at bedtime or by using anti-fever medicines (eg, acetaminophen).
  • You should be completely comfortable with how to prepare the injection, how to set the dose you take, and how to inject yourself before you use Peginterferon alfa-2b the first time.
  • Carefully follow the procedures for injection and disposal of needles and syringes as instructed by your health care provider.
  • The mixed medicine should be clear and colorless. Do not use if the solution is discolored or cloudy, or if particles are present.
  • Discard used syringes and needles in a Sharp"s container (available at your local pharmacy) or other puncture-proof container, like a coffee can. Do not use glass or clear plastic containers. Your health care provider will instruct as to how to dispose of a full container. Always keep the container out of the reach of children.
  • Two hours after the injection, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your health care provider.
  • If you miss a dose, 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 doctor about what to do. Do not double the next dose or take more than one dose a week without talking to your doctor. Call your doctor right away if you take more than the prescribed dose. Your doctor may wish to examine you more closely, and take blood for testing.

Ask your health care provider any questions you may have about how to use Peginterferon alfa-2b .

Important safety information:

  • Limit alcoholic drinks while on Peginterferon alfa-2b .
  • It is not known if Peginterferon alfa-2b will prevent the spread of hepatitis C virus to others. It is also not known if it will cure hepatitis C or prevent liver disease (eg, cirrhosis, liver failure, liver cancer) that may be associated with hepatitis C virus.
  • Peginterferon alfa-2b may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rashes, or chills.
  • Peginterferon alfa-2b may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark tarry stools to your doctor.
  • Notify your dentist or doctor that you are taking Peginterferon alfa-2b before you have any dental work or surgery.
  • Peginterferon alfa-2b may cause high blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor). If these symptoms occur, tell your doctor immediately.
  • LAB TESTS, such as blood tests and virus levels, as well as eye exams will be required before you start using Peginterferon alfa-2b and periodically thereafter to monitor therapy. Be sure to keep all doctor and lab appointments.
  • ELDERLY patients may be more sensitive to the effects of Peginterferon alfa-2b and are at an increased risk for serious side effects.
  • Peginterferon alfa-2b is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Peginterferon alfa-2b if you are pregnant. To prevent pregnancy during the treatment period, it is recommended that effective contraception be used during treatment with Peginterferon alfa-2b . If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Peginterferon alfa-2b is excreted in breast milk. Do not breast-feed while taking Peginterferon alfa-2b .

Possible side effects of Peginterferon alfa-2b :

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

Extreme tiredness; feeling hot or cold all the time; flu-like symptoms (headache; tiredness; muscle aches); hair thinning or loss; inability to concentrate; increased appetite; increased sweating; loss of appetite; nausea; rash; skin changes; skin reactions at the injection site (redness; itching; swelling); weight change; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal or fast heartbeat; aggression; bizarre behavior; bleeding; bruising; depression; bloody stools or diarrhea; decreased or blurred vision; chest congestion; chest pain; exaggerated sense of well-being; hallucinations; fever, chills, or sore throat; increased thirst or urination; pneumonia; relapse of drug or alcohol addiction/overdose; severe stomach or lower back pain; shortness of breath; suicidal thoughts or behaviors or thoughts hurting yourself or other people; trouble breathing; unusual or severe mental/mood changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Peginterferon alfa-2b :

Redipen: Store Peginterferon alfa-2b in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). The prepared solution should be used immediately, but may be stored for up to 24 hours in a refrigerator between 36 and 46 degrees F (2 and 8 degrees C).

Vial: Store the powder at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid exposure to heat. After mixing, the solution should be used immediately. Mixed solution may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) for up to 24 hours.

The solution does not contain a preservative. Do not freeze. Keep Peginterferon alfa-2b out of the reach of children and away from pets.

General information:

  • If you have any questions about Peginterferon alfa-2b , please talk with your doctor, pharmacist, or other health care provider.
  • Peginterferon alfa-2b is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Peginterferon alfa-2b . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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