Peginterferon alfa-2a may cause or worsen the following conditions which may be serious or cause death: infections; mental illness including depression, mood and behavior problems, or thoughts of hurting or killing yourself; starting to use street drugs again if you used them in the past; ischemic disorders (conditions in which there is poor blood supply to an area of the body) such as angina (chest pain), heart attack, or colitis (inflammation of the bowels); and autoimmune disorders (conditions in which the immune system attacks one or more parts of the body) that may affect the blood, joints, kidneys, liver, lungs, muscles, skin, or thyroid gland.Tell your doctor if you have an infection; or if you have or have ever had an autoimmune disease; atherosclerosis (narrowing of the blood vessels from fatty deposits); cancer; chest pain; colitis; diabetes; heart attack; high blood pressure; high cholesterol; HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome); irregular heartbeat; mental illness including depression, anxiety, or thinking about or trying to kill yourself; liver disease other than hepatitis B or C; or heart, kidney, lung or thyroid disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, or if you use or have ever used street drugs or have overused prescription medications. If you experience any of the following symptoms, call your doctor immediately: bloody diarrhea or bowel movements; stomach pain, tenderness or swelling; chest pain; irregular heartbeat; changes in your mood or behavior; depression; irritability; anxiety; thoughts of killing or hurting yourself ; hallucinating (seeing things or hearing voices that do not exist); frenzied or abnormally excited mood; loss of contact with reality; aggressive behavior; difficulty breathing; fever, chills, cough, sore throat, or other signs of infection; unusual bleeding or bruising; dark-colored urine; light colored bowel movements; extreme tiredness; yellowing of the skin or eyes; severe muscle or joint pain; or worsening of an autoimmune disease.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to peginterferon alfa-2a.
Your doctor and pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with peginterferon alfa-2a and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using peginterferon alfa-2a.
Use with ribavirin (Copegus, Rebetol):
You may take peginterferon with another medication called ribavirin (Copegus, Rebetol). Ribavirin may help peginterferon work better to treat your condition, but it may also cause serious side effects. The rest of this section tells about the risks of taking ribavirin. Your doctor and pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ribavirin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide
Ribavirin may cause anemia (condition in which there is a decrease in the number of red blood cells). Tell your doctor if you have ever had a heart attack and if you have or have ever had high blood pressure, breathing problems, any condition that affects your blood such as sickle cell anemia (inherited condition in which the red blood cells are abnormally shaped and cannot bring oxygen to all parts of the body) or thalassemia (Mediterranean anemia; a condition in which the red blood cells do not contain enough of the substance needed to carry oxygen), or heart disease. If you experience any of the following symptoms, call your doctor immediately: excessive tiredness, pale skin, headache, dizziness, confusion, fast heartbeat, weakness, shortness of breath, or chest pain.
For female patients who are taking ribavirin:
Do not take ribavirin if you are pregnant or plan to become pregnant. You should not start taking ribavirin until a pregnancy test has shown that you are not pregnant. You must use two forms of birth control and be tested for pregnancy every month during your treatment and for 6 months afterward. Call your doctor immediately if you become pregnant during this time. Ribavirin may cause harm or death to the fetus.
For male patients who are taking ribavirin:
Do not take ribavirin if your partner is pregnant or plans to become pregnant. If you have a partner who can become pregnant, you should not start taking ribavirin until a pregnancy test shows that she is not pregnant. You must use two forms of birth control, including a condom with spermicide during your treatment and for 6 months afterward. Your partner must be tested for pregnancy every month during this time. Call your doctor immediately if your partner becomes pregnant. Ribavirin may cause harm or death to the fetus.
Peginterferon alfa-2a is used alone or in combination with ribavirin (a medication) to treat chronic (long-term) hepatitis C infection (swelling of the liver caused by a virus) in people who show signs of liver damage and who have not been treated with interferon alpha (medication similar to peg-interferon alfa-2a) in the past. Peginterferon alfa-2a is also used to treat chronic hepatitis B infection (swelling of the liver caused by a virus) in people who show signs of liver damage. Peginterferon alfa-2a is in a class of medications called interferons. Peginterferon is a combination of interferon and polyethylene glycol, which helps the interferon stay active in your body for a longer period of time. Peginterferon works by decreasing the amount of hepatitis C virus (HCV) or hepatitis B virus (HBV) in the body. Peginterferon alfa-2a may not cure hepatitis C or hepatitis B or prevent you from developing complications of hepatitis C or hepatitis B such as cirrhosis (scarring) of the liver, liver failure, or liver cancer.Peginterferon alfa-2a may not prevent the spread of hepatitis C or hepatitis B to other people.
Peginterferon alfa-2a comes as a solution (liquid) in a vial and a prefilled syringe to inject subcutaneously (into the fatty layer just under the skin). It is usually injected once a week, on the same day of the week, and at around the same time of day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use peginterferon alfa-2a exactly as directed. Do not use more or less of this medication or use it more often than prescribed by your doctor.
Your doctor will probably start you on an average dose of peginterferon alfa-2a. Your doctor may decrease your dose if you experience serious side effects of the medication. Be sure to tell your doctor how you are feeling during your treatment and ask your doctor or pharmacist if you have questions about the amount of medication you should take.
Continue to use peginterferon alfa-2a even if you feel well. Do not stop using peginterferon alfa-2a without talking to your doctor.
Only use the brand and type of interferon that your doctor prescribed. Do not use another brand of interferon or switch between peginterferon alfa-2a in vials and prefilled syringes without talking to your doctor. If you switch to a different brand or type of interferon, your dose may need to be changed.
You can inject peg-interferon alfa-2a yourself or have a friend or relative give you the injections. Before you use peg-interferon alfa-2a for the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. If another person will be injecting the medication for you, be sure that he or she knows how to avoid accidental needlesticks to prevent the spread of hepatitis.
You can inject peginterferon alfa-2a anywhere on your stomach or thighs, except your navel (belly button) and waistline. Use a different spot for each injection. Do not use the same injection spot two times in a row. Do not inject peginterferon alfa-2a into an area where the skin is sore, red, bruised, scarred, infected, or abnormal in any way.
Never reuse syringes, needles, or vials of peginterferon alfa-2a. Throw away used needles and syringes in a puncture resistant container, and throw away used vials of medication in the trash. Talk to your doctor or pharmacist about how to dispose of the puncture resistant container.
Before you use peginterferon alfa-2a, look at the solution in the vial or the prefilled syringe closely. It should be clear and free of floating particles. Check the vial or syringe to make sure there are no leaks and check the expiration date. Do not use the solution if it is expired, discolored, cloudy, contains particles, or is in a leaky vial or syringe. Use a new solution, and show the damaged or expired one to your doctor or pharmacist.
To prepare peginterferon alfa-2a in vials for injection, follow these steps:
To prepare a prefilled syringe of peginterferon alfa-2a, follow these steps:
To inject a dose of peginterferon alfa-2a, follow these steps:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before using peginterferon alfa-2a,
Drink plenty of fluids while you are taking this medication.
If you remember the missed dose no longer than 2 days after you were scheduled to inject it, inject the missed dose as soon as you remember it. Then inject your next dose on your regularly scheduled day the following week. If more than 2 days have passed since the day you were scheduled to inject the medication, ask your doctor or pharmacist what you should do. Do not use a double dose or use more than one dose in 1 week to make up for a missed dose.
Peginterferon alfa-2a may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
Peginterferon alfa-2a may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. Do not leave peginterferon alfa-2a outside of the refrigerator for more than 24 hours (1 day). Keep peginterferon alfa-2a away from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
If the victim has not collapsed, call the doctor who prescribed this medication. The doctor may want to order lab tests.
Symptoms of overdose may include
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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