Peginterferon alfa-2b may cause or worsen the following conditions that may be serious or cause death: infections; mental illness including depression, mood and behavior problems, or thoughts of hurting or killing yourself or others; 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 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-2b.
Your doctor and pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with peginterferon alfa-2b 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-2b.
Use with ribavirin (Copegus, Rebetol):
You may take peginterferon alpha-2b with another medication called ribavirin (Copegus, Rebetol). Ribavirin may help peginterferon alpha-2b work better to treat your condition, but it may also cause serious side effects. The rest of this section presents the risks of taking ribavirin. If you are taking ribavirin, you should read this information carefully. 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-2b 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 peginterferon alfa-2b) in the past. Peginterferon alfa-2b is in a class of medications called interferons. Peginterferon alpha-2b is a combination of interferon and polyethylene glycol, which helps the interferon stay active in your body for a longer period of time. Peginterferon alpha-2b works by decreasing the amount of hepatitis C virus (HCV) in the body. Peginterferon alfa-2b may not cure hepatitis C or prevent you from developing complications of hepatitis C such as cirrhosis (scarring) of the liver, liver failure, or liver cancer. Peginterferon alfa-2b may not prevent the spread of hepatitis C to other people.
Peginterferon alfa-2b comes as a powder in a vial and in a single dose injection pen to mix with liquid and inject subcutaneously (in the fatty layer just under the skin). It is usually injected once a week on the same day of the week, at or 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-2b exactly as directed. Do not use more or less of this medication or use it more often or for a longer period of time than prescribed by your doctor.
Peginterferon alfa-2b controls hepatitis C but may not cure it. Continue to use peginterferon alfa-2b even if you feel well. Do not stop using peginterferon alfa-2b 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-2b in vials and injection pens 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 peginterferon alfa-2b yourself or have a friend or relative give you the injections. Before you use peginterferon alfa-2b 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 needle sticks to prevent the spread of HCV.
You can inject peginterferon alfa-2b anywhere on the outer part of your upper arms, your thighs, or your stomach except your navel (belly button) and waist. Do not inject into your stomach if you are very thin. Use a different spot for each injection. Do not inject peginterferon alfa-2b into an area where the skin is sore, red, bruised, scarred, irritated, or infected; has stretch marks or lumps; or is abnormal in any way.
Never reuse or share syringes, needles, injection pens, or vials of medication. Dispose of used needles, syringes, and injection pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
To use peginterferon alfa-2b injection pen, follow these steps:
To use peginterferon alfa-2b in vials, follow these steps:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking peginterferon alfa-2b,
Drink at least 10 full glasses of water or clear juices without caffeine or alcohol every day during your treatment with peginterferon alfa-2b. Be especially careful to drink enough fluid during the first weeks of your treatment.
Be sure to eat well during your treatment. If you have an upset stomach or don't have an appetite, eat healthy snacks or several smaller meals throughout the day.
If you remember the missed dose no later than the day 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 you do not remember the missed dose until several days have passed, 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.
Peginterferon alfa-2b 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-2b 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 ( 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 peginterferon alfa-2b injection pens in the refrigerator, and do not expose them to heat. Store vials of peginterferon alfa-2b powder at room temperature and away from excess heat and moisture (not in the bathroom).It is best to inject peginterferon alfa-2b solution in vials or injection pens immediately after mixing. If necessary, vials or injection pens containing prepared peginterferon alfa-2b solution may be stored in the refrigerator for up to 24 hours. Do not freeze peginterferon alfa-2b.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
If the victim has not collapsed, call the doctor who prescribed this medication. The doctor may want to examine the victim more closely and perform laboratory tests.
Do not let anyone else use your medication or any of your injection supplies. 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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: June 15, 2016.