PEG-Intron

Generic Name: peginterferon alfa-2b (peg in ter FEAR on AL fa 2 b)

What is PEG-Intron?

PEG-Intron is made from human proteins that help the body fight viral infections.

PEG-Intron is used to treat chronic hepatitis C in adults. PEG-Intron is used in combination with another medication called ribavirin to treat hepatitis C in adults and children who are at least 3 years old.

PEG-Intron may also be used for other purposes not listed in this medication guide.

Important information about PEG-Intron

You should not use PEG-Intron if you are allergic to peginterferon alfa-2b, or if you have autoimmune hepatitis, severe liver or kidney disease, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia. PEG-Intron 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 PEG-Intron and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using PEG-Intron, 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.

There are many other medicines that can interact with PEG-Intron. 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.

Before using PEG-Intron

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

autoimmune hepatitis;

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.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use PEG-Intron:

lung disease;

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.

PEG-Intron may be harmful to an unborn baby. Do not use PEG-Intron without telling your doctor if you are pregnant. PEG-Intron 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 PEG-Intron and ribavirin if you are pregnant.

If you are a man, do not use PEG-Intron 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 PEG-Intron 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 PEG-Intron together with ribavirin.

It is not known whether peginterferon alfa-2b passes into breast milk or if it could harm a nursing baby. Do not use PEG-Intron without telling your doctor if you are breast-feeding a baby. PEG-Intron 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 PEG-Intron?

PEG-Intron is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine 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.

PEG-Intron is usually given once per week. Your doctor may occasionally change your dose to make sure you get the best results from PEG-Intron.

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 vial (bottle) or Redipen while mixing. Vigorous shaking can ruin the medicine. Do not draw your PEG-Intron dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

To be sure PEG-Intron 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 this medication 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 if you think you have used too much of this medicine. Symptoms of a PEG-Intron overdose are not known.

What should I avoid while using PEG-Intron?

Treatment with PEG-Intron 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.

PEG-Intron side effects

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 PEG-Intron and call your doctor at once if you have any of these serious side effects:

confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;

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 PEG-Intron 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 PEG-Intron?

Many drugs can interact with PEG-Intron. Below is just a partial list. Tell your doctor if you are using:

a blood thinner such as warfarin (Coumadin);

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 PEG-Intron. 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.