What is PegIntron?
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 that:
- may cause death, or
- may worsen certain serious diseases that you may already have.
Tell your healthcare provider right away if you have any of the symptoms listed below while taking PegIntron. If symptoms get worse, or become severe and continue, your healthcare provider may tell you to stop taking PegIntron permanently. In many, but not all, people, these symptoms go away after they stop taking PegIntron.
- 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
If you have these symptoms, your healthcare provider should carefully monitor you during treatment with PegIntron and for 6 months after your last dose.
- 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.
While taking PegIntron, you should see a healthcare provider regularly for check-ups and blood tests to make sure that your treatment is working, and to check for side effects.
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.
- PegIntron comes as a:
- powder in a single-use vial
- single-use REDIPEN
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Important Safety Information
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Ask your healthcare provider if you do not know.
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You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
General information about _________
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Active ingredient:
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This Patient Information has been approved by the U.S. Food and Drug Administration.
Please see full Prescribing Information for additional Important Safety Information.