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|PEG-Intron

PEG-Intron

PEG-Intron is used for:

The treatment of chronic hepatitis C virus infection. PEG-Intron is used alone or with other medicines.

PEG-Intron 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 PEG-Intron if:

• you are allergic to any ingredient in PEG-Intron 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 PEG-Intron :

Some medical conditions may interact with PEG-Intron . 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 PEG-Intron . 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 PEG-Intron 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 PEG-Intron :

Use PEG-Intron as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• PEG-Intron comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get PEG-Intron refilled.
• Drink plenty of fluids while you are taking PEG-Intron .
• Take your prescribed dose of PEG-Intron 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 PEG-Intron 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 PEG-Intron 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 PEG-Intron .

Important safety information:

• Limit alcoholic drinks while on PEG-Intron .
• It is not known if PEG-Intron 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.
• PEG-Intron 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.
• PEG-Intron 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 PEG-Intron before you have any dental work or surgery.
• PEG-Intron 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 PEG-Intron 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 PEG-Intron and are at an increased risk for serious side effects.
• PEG-Intron 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 PEG-Intron if you are pregnant. To prevent pregnancy during the treatment period, it is recommended that effective contraception be used during treatment with PEG-Intron . If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if PEG-Intron is excreted in breast milk. Do not breast-feed while taking PEG-Intron .

Possible side effects of PEG-Intron :

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.

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.

Redipen: Store PEG-Intron 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 PEG-Intron out of the reach of children and away from pets.

General information:

• If you have any questions about PEG-Intron , please talk with your doctor, pharmacist, or other health care provider.
• PEG-Intron 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 PEG-Intron . 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.