peginterferon alfa-2b

What is the most important information I should know about peginterferon alfa-2b?

You should not use peginterferon alfa-2b if you are allergic to it, or if you have autoimmune hepatitis, severe liver or kidney disease, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia.

Peginterferon alfa-2b is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab), which is known to cause birth defects or death in an unborn baby. Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using peginterferon alfa-2b, tell your doctor about all of your medical conditions, especially kidney disease, liver problems other than hepatitis, heart disease or high blood pressure, a thyroid disorder, eye problems, HIV or AIDS, ulcerative colitis, a blood cell disorder, an autoimmune disorder such as lupus or psoriasis, or a history of heart attack, stroke, organ transplant, depression, mental illness, drug or alcohol addiction, or suicidal thoughts or behaviors.

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it again.

There are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use.

What is peginterferon alfa-2b?

Peginterferon alfa-2b is made from human proteins that help the body fight viral infections.

Peginterferon alfa-2b is used to treat chronic hepatitis C in adults. Peginterferon alfa-2b is often used in combination with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab) to treat hepatitis C in adults and children who are at least 3 years old.

Peginterferon alfa-2b may be used in combination with boceprevir (Victrelis) or telaprevir (Incivek) to treat hepatitis C in adults.

The Sylatron brand of peginterferon alfa-2b is used to treat melanoma (skin cancer) after surgery.

Peginterferon alfa-2b may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using peginterferon alfa-2b?

You should not use this medication if you are allergic to peginterferon alfa-2b, or if you have:

• autoimmune hepatitis;
• liver failure;
• severe kidney disease;
• a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
• if you are pregnant; or
• if you are a man and your female sexual partner is pregnant.

To make sure you can safely use peginterferon alfa-2b, tell your doctor if you have any of these other conditions:

• lung disease;
• kidney disease (or if you are on dialysis);
• hepatitis B, or liver problems other than hepatitis;
• a thyroid disorder;
• uncontrolled diabetes;
• new or worsening problems with your eyes;
• cancer;
• HIV or AIDS;
• pancreatitis or ulcerative colitis;
• heart disease, high blood pressure, high cholesterol or triglycerides, or a history of heart attack, or stroke;
• dental problems or gum disease;
• an allergy causing severe reaction;
• history of organ transplant;
• anemia (low red blood cells) caused by taking ribavirin (Rebetol);
• any blood cell disorder causing bleeding episodes, infections, or fever-related illness;
• an autoimmune disorder such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or psoriasis; or
• a history of drug or alcohol addiction, depression, anxiety, or suicidal thoughts or behaviors.

Peginterferon alfa-2b may be harmful to an unborn baby. Do not use peginterferon alfa-2b without telling your doctor if you are pregnant.

Peginterferon alfa-2b is often used together with another medication called ribavirin (Copegus). Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking these two medications together and every month during your treatment.

• If you are a woman, do not use peginterferon alfa-2b and ribavirin if you are pregnant.
• If you are a man, do not use peginterferon alfa-2b and ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
• Use at least 2 effective forms of birth control while either sexual partner is using peginterferon alfa-2b with ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using peginterferon alfa-2b together with ribavirin.

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using peginterferon alfa-2b.

Peginterferon alfa-2b can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I use peginterferon alfa-2b?

Peginterferon alfa-2b is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Peginterferon alfa-2b is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

If you are being treated with combination therapy, you will also take ribavirin (Rebetol) capsules or liquid by mouth every day. Ribavirin should be taken with food.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

To be sure this medication is helping your condition and not causing harmful effects, your blood may need to be tested on a regular basis. You may also need regular eye exams. Do not miss any scheduled appointments.

Store peginterferon alfa-2b in the refrigerator, protected from light. Do not allow the medicine to freeze. Mixed medicine may be stored in the refrigerator but you must use it within 24 hours after mixing.

The PegIntron Redipen and single-use vials are for one use only. Do not reuse a vial or injection pen.

What happens if I miss a dose?

Use the medicine as soon as you remember the missed dose, then go back to your regular schedule on the day your next dose is due. If you are more than 2 days late in using your injection, call your doctor for instructions. Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using peginterferon alfa-2b?

Treatment with this medication does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

What are the possible side effects of peginterferon alfa-2b?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it again.

Stop using peginterferon alfa-2b and call your doctor at once if you have any of these serious side effects:

• vision problems;
• fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;
• high fever with severe stomach pain and bloody diarrhea.
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• cough, feeling short of breath, chest pain, uneven heartbeats;
• sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance; or
• new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Less serious side effects may include:

• dizziness, tired feeling;
• headache, joint or muscle pain;
• nausea, dry mouth, loss of appetite, weight loss;
• sleep problems (insomnia);
• feeling mildly anxious, depressed, or irritable; or
• pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect peginterferon alfa-2b?

Many drugs can interact with peginterferon alfa-2b. Below is just a partial list. Tell your doctor if you are using:

• a blood thinner such as warfarin (Coumadin, Jantoven);
• fosphenytoin (Cerebyx) or phenytoin (Dilantin);
• methadone (Diskets, Dolophine, Methadose);
• ADHD medication such as Adderall, Ritalin, and others;
• rifampin (Rifadin, Rifater, Rifamate);
• voriconazole (Vfend);
• an antidepressant or anti-psychotic medication;
• cancer medication such as doxorubicin (Adriamycin), lomustine (Ceenu), paclitaxel (Taxol), or tamoxifen (Soltamox);
• cough medicine (prescription or over-the-counter);
• diabetes medications you take by mouth;
• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), captopril (Capoten), carvedilol (Coreg), flecainide (Tambocor), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal), and others;
• HIV or AIDS medication;
• medicines used to prevent organ transplant rejection; or
• a sulfa drug (Bactrim, Cotrim, Gantanol, Septra, SMX-TMP, and others).

This list is not complete and there are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about peginterferon alfa-2b.