What is PegIntron (Peginterferon alfa-2b)?
PegIntron is a prescription medicine that is used:
- With REBETOL (ribavirin) and an approved hepatitis C virus (HCV) protease inhibitor to treat chronic (lasting a long time) hepatitis C infection in adults.
- With REBETOL (ribavirin) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with stable liver problems.
- Alone, sometimes to treat adults who have chronic (lasting a long time) hepatitis C infection with stable liver problems and who cannot take REBETOL (ribavirin).
People with hepatitis C have the virus in their blood and in their liver. PegIntron reduces the amount of virus in the body and helps the body’s immune system fight the virus. REBETOL (ribavirin) is a drug that helps to fight the viral infection but does not work when used by itself to treat chronic hepatitis C.
It is not known if PegIntron use for longer than 1 year is safe and will work.
It is not known if PegIntron use in children younger than 3 years old is safe and will work
What is the most important information I should know about PegIntron ?
PegIntron can cause serious side effects. These serious side effects include:
- Mental health problems, including suicide. PegIntron may cause you to develop mood or behavior problems that may get worse during treatment with PegIntron or after your last dose, including:
- Irritability (getting upset easily)
- Depression (feeling low, feeling bad about yourself, or feeling hopeless)
- Acting aggressive, being angry or violent
- Thoughts of hurting yourself or others, or suicide
- Former drug addicts may fall back into drug addiction or overdose
- Heart problems. Some people who take PegIntron may get heart problems, including:
- Low blood pressure
- Fast heart rate or abnormal heart beat
- Trouble breathing or chest pain
- Heart attacks or heart muscle problems (cardiomyopathy
- Stroke or symptoms of a stroke. Symptoms may include weakness, loss of coordination, and numbness. Stroke or symptoms of a stroke may happen in people who have some risk factors or no known risk factors for a stroke.
- New or worsening autoimmune problems. Some people taking PegIntron develop autoimmune problems (a condition where the body's immune cells attack other cells or organs in the body), including rheumatoid arthritis, systemic lupus erythematosus, and psoriasis. In some people who already have an autoimmune problem, it may get worse during your treatment with PegIntron.
- Infections. Some people who take PegIntron may get an infection. Symptoms may include: Fever , Chills, Bloody diarrhea , Burning or pain with urination, Urinating often , Coughing up mucus (phlegm) that is discolored (for example, yellow or pink)
- PegIntron in combination with REBETOL (ribavirin) may cause birth defects or the death of your unborn baby. Do not take PegIntron and ribavirin combination therapy if you or your sexual partner is pregnant or plan to become pregnant. Do not become pregnant within 6 months after discontinuing PegIntron and ribavirin combination therapy. You must use 2 forms of birth control when you take PegIntron and ribavirin and for the 6 months after treatment.
- Females must have a pregnancy test before starting PegIntron and ribavirin combination therapy, every month while on the combination therapy, and every month for the 6 months after the last dose of combination therapy.
- If you or your female sexual partner becomes pregnant while taking PegIntron and ribavirin combination therapy or within 6 months after you stop taking the combination therapy, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin pregnancy registry by calling 1-800-593-2214. The Ribavirin pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin while she is pregnant.
- Serious eye problems.
- Blood problems.
- Swelling of your pancreas (pancreatitis) or intestines (colitis).
- Lung problems including: Trouble breathing, Pneumonia, Inflammation of lung tissue, New or worse high blood pressure of the lungs (pulmonary hypertension). This can be severe and may lead to death
- Severe liver problems, or worsening of liver problems, including liver failure and death
- Thyroid problems.
- Blood sugar problems.
- Serious allergic reactions and skin reactions.
- Growth problems in children.
- Nerve problems.
- Dental and gum problems.
- The most common side effects of PegIntron include: Flu-like symptoms, Tiredness. Appetite problems, Skin reactions, Hair thinning
How should I take PegIntron?
- Take PegIntron exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much PegIntron to take and when to take it. Do not take more than your prescribed dose.
- Take your prescribed dose of PegIntron every week, on the same day of each week and at the same time.
- PegIntron is given as an injection under your skin (subcutaneous injection). Your healthcare provider should show you how to prepare and measure your dose of PegIntron, and how to inject yourself before you use PegIntron for the first time.
- You should not inject PegIntron until your healthcare provider has shown you how to use PegIntron the right way.
- If you miss a dose of PegIntron, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your healthcare provider about what to do.
- Do not inject more than 1 dose of PegIntron in one week without talking to your healthcare provider.
- If you take too much PegIntron, call your healthcare provider right away. Your healthcare provider may examine you more closely, and do blood tests.
- Your healthcare provider should do blood tests before you start PegIntron, and regularly during treatment to see how well the treatment is working and to check you for side effects.
Important Safety Information
Do not take PegIntron:
- If you have had a serious allergic reaction to another alpha interferon or to any of the ingredients in PegIntron. See the end of this Medication Guide for a complete list of ingredients. Ask your healthcare provider if you are not sure.
- If you have certain types of hepatitis (autoimmune hepatitis).
- If you have certain other liver problems.
- With REBETOL (ribavirin) if you are pregnant, planning to get pregnant, or breastfeeding.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking PegIntron?
Tell your healthcare provider if you:
- Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and thoughts of hurting yourself or others
- Have or ever had any problems with your heart, including heart attack or high blood pressure
- Have any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus, rheumatoid arthritis
- Have or ever had bleeding problems or a blood clot
- Have or ever had low blood cell counts
- Have ever been addicted to drugs or alcohol
- Have cirrhosis or other liver disease (other than hepatitis C infection)
- Have or had lung disease such as chronic obstructive pulmonary disease (COPD)
- Have thyroid problems
- Have diabetes
- Have colitis (inflammation of your intestine)
- Have a condition that suppresses your immune system, such as cancer
- Have hepatitis B infection
- Have HIV infection
- Have kidney problems
- Have high blood triglyceride levels (fat in your blood)
- Have an organ transplant and are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system)
- Have any other medical problems
- Are pregnant or plan to become pregnant. PegIntron may harm your unborn baby. You should use effective birth control during treatment with PegIntron. Talk to your healthcare provider about birth control choices for you during treatment with PegIntron. Tell your healthcare provider if you become pregnant during treatment with PegIntron.
- Are breastfeeding or plan to breastfeed. It is not known if PegIntron passes into your breast milk. You and your healthcare provider should decide if you will use PegIntron or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. PegIntron and certain other medicines may affect each other and cause side effects.
General information about PegIntron
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PegIntron for a condition for which it was not prescribed. Do not give PegIntron to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in PegIntron?
Active ingredient: Peginterferon alfa-2b
Inactive ingredient: Dibasic sodium phosphate anhydrous, monobasic sodium phosphate dihydrate, sucrose, polysorbate 80. Sterile water for injection is supplied as a diluent.