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|Peginterferon Alfa-2a

Peginterferon Alfa-2a

Peginterferon Alfa-2a is used for:

Treating chronic hepatitis C infection in patients who have controlled liver disease and have not been previously treated with interferon alfa. Peginterferon Alfa-2a is used either alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Peginterferon Alfa-2a is an interferon. It works by reducing the amount of hepatitis C virus in the body. It also helps the immune system fight the virus.

Do NOT use Peginterferon Alfa-2a if:

• you are allergic to any ingredient in Peginterferon Alfa-2a , ribavirin, or another alpha interferon
• you are pregnant or breast-feeding
• you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or you have unstable or severe liver disease

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

Before using Peginterferon Alfa-2a :

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

• if you are planning to become pregnant
• 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 history of heart problems or heart attack, kidney problems, bone marrow problems, blood or bleeding disorders (eg, sickle cell anemia or thalassemia major), thyroid problems, lung problems (eg, asthma, pneumonia), stomach or intestinal problems (eg, colitis, blood in the stools or vomit), pancreas problems, or eye problems
• if you have a history of autoimmune disease (eg, psoriasis, lupus, rheumatoid arthritis), cancer, diabetes, high cholesterol or lipids in your blood, HIV infection, liver problems other than hepatitis C (eg, cirrhosis, hepatitis B infection), organ transplant, or seizures
• if you have a history of mental or mood problems (eg, depression, anxiety), suicidal thoughts or behaviors, or drug or substance abuse

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

• Nucleoside reverse transcriptase inhibitors (eg, zidovudine) because the risk of anemia may be increased
• Methadone or theophylline because side effects may be increased by Peginterferon Alfa-2a

This may not be a complete list of all interactions that may occur. Ask your health care provider if Peginterferon Alfa-2a 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-2a :

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

• Peginterferon Alfa-2a comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Peginterferon Alfa-2a refilled.
• Peginterferon Alfa-2a is sometimes used with another medicine called ribavirin, which comes with its own Medication Guide. If you are also using ribavirin, be sure to read its Medication Guide carefully each time you get it filled.
• Peginterferon Alfa-2a is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Peginterferon Alfa-2a at home, carefully follow the injection procedures taught to you by your health care provider.
• Do not use another brand of Peginterferon Alfa-2a without talking with your doctor.
• If the expiration date of Peginterferon Alfa-2a has passed, if the medicine contains particles or is discolored, or if the vial or prefilled syringe is cracked or damaged in any way, do not use it.
• Do not shake Peginterferon Alfa-2a .
• Be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. Carefully check that you have drawn the correct dose before administration.
• Each vial or prefilled syringe is for a single use only. Throw away any unused medicine.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• Use Peginterferon Alfa-2a regularly to receive the most benefit from it. Using Peginterferon Alfa-2a at the same time each week will help you remember to use it.
• Continue to use Peginterferon Alfa-2a even if you feel well. Do not miss any doses.
• If you miss a dose of Peginterferon Alfa-2a and you remember within 2 days of the missed dose, use it as soon as possible and go back to your regular dosing schedule. If more than 2 days have passed since the missed dose, do not use it and contact your doctor. Do not use 2 doses at once.

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

Important safety information:

• Peginterferon Alfa-2a may cause drowsiness, dizziness, or vision changes. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Peginterferon Alfa-2a . Using Peginterferon Alfa-2a alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Peginterferon Alfa-2a may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Peginterferon Alfa-2a 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, rash, or chills.
• Peginterferon Alfa-2a is not a cure for hepatitis C infection and may not prevent you from spreading hepatitis C infection to others.
• Peginterferon Alfa-2a may cause high or low blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor, fast heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). If these symptoms occur, tell your doctor immediately.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Peginterferon Alfa-2a .
• LAB TESTS, including eye exams; pregnancy tests; blood counts; blood pressure; heart, liver, kidney, thyroid, and lung function tests; blood glucose levels; and other blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Peginterferon Alfa-2a contains benzyl alcohol, a preservative. Do not use Peginterferon Alfa-2a in NEWBORNS or INFANTS because serious and sometimes fatal nervous system problems and other side effects may occur.
• Use Peginterferon Alfa-2a with caution in the ELDERLY because they may be more sensitive to its effects, especially heart effects, nervous system effects, and systemic side effects (eg, flu-like symptoms).
• Use Peginterferon Alfa-2a with extreme caution in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Peginterferon Alfa-2a . If you become pregnant while taking Peginterferon Alfa-2a , discuss with your doctor the benefits and risks of using Peginterferon Alfa-2a during pregnancy. Use of Peginterferon Alfa-2a with ribavirin during pregnancy has resulted in birth defects and fetal death. If you think you may be pregnant, contact your doctor immediately. It is unknown if Peginterferon Alfa-2a is excreted in breast milk. Do not breast-feed while taking Peginterferon Alfa-2a .

Possible side effects of Peginterferon Alfa-2a :

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:

Diarrhea; dizziness; drowsiness; dry mouth; dry or irritated skin; hair thinning; headache; loss of appetite; nausea; pain, redness, or swelling at the injection site; taste changes; temporary hair loss; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; burning, numbness, or tingling in the arms, hands, legs, or feet; chest pain; confusion; dark urine or an unusual increase or decrease in the amount of urine produced; difficulty hearing or hearing loss; fast, slow, or irregular heartbeat; flu-like symptoms (eg, chills, fever, persistent sore throat); joint or muscle pain; unusual mental or mood changes (eg, anxiety, aggressive or unusual behavior, depression, hallucinations, irritability, suicidal thoughts or behavior); one-sided weakness; persistent or severe diarrhea, nausea, stomach pain, or vomiting; severe or unusual tiredness; sudden leg pain; sudden severe dizziness, fainting, headache, or vomiting; sudden shortness of breath; unusual bruising or bleeding; unusually increased thirst; unusually pale stools or dark, tarry stools; vision changes; weight loss; worsening psoriasis; yellowing of the eyes or skin.

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.

Store Peginterferon Alfa-2a in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Peginterferon Alfa-2a out of the reach of children and away from pets.

General information:

• If you have any questions about Peginterferon Alfa-2a , please talk with your doctor, pharmacist, or other health care provider.
• Peginterferon Alfa-2a 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-2a . 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.