The best practices for managing hepatitis C treatment include using a patient support program; The Be In Charge® Program, a service of Schering Corporation, is the longest running hepatitis patient support program in the world.
What is the most important information I should know
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PEGINTRON® (peginterferon) is a treatment for some people who are infected with hepatitis C virus. However, PEGINTRON® and PEGINTRON®/REBETOL® combination therapy can have serious side effects that may cause death in rare cases. Before you decide to start treatment, you should talk to your health care provider about the possible benefits and side effects of PEGINTRON® or PEGINTRON®/REBETOL® combination therapy. If you begin treatment you will need to see your health care provider regularly for medical examinations and lab tests to make sure your treatment is working and to check for side effects.
REBETOL® may cause birth defects and/or death of an unborn child. If you are pregnant, you or your male partner must not take PEGINTRON®/REBETOL® combination therapy. You must not become pregnant while either you or your partner are being treated with the combination PEGINTRON®/REBETOL® therapy, or for 6 months after stopping therapy. Men and women should use birth control while taking the combination therapy and for 6 months afterwards. If you or your partner are being treated and you become pregnant either during treatment or within 6 months of stopping treatment, call your health care provider right away. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your health care provider are encouraged to contact the Registry at 1-800-593-2214.
If you are taking PEGINTRON® or PEGINTRON®/REBETOL® therapy you should call your health care provider immediately if you develop any of these symptoms:
New or worsening mental health problems such as thoughts about killing or hurting yourself or others, trouble breathing, chest pain, severe stomach or lower back pain, bloody diarrhea or bloody bowel movements, high fever, bruising, bleeding, or decreased vision.
The most serious possible side effects of PEGINTRON® and PEGINTRON®/REBETOL® therapy include:
Problems with Pregnancy. Combination PEGINTRON®/REBETOL® therapy can cause death, serious birth defects, or other harm to your unborn child. If you are a woman of childbearing age, you must not become pregnant during treatment and for 6 months after you have stopped therapy. You must have a negative pregnancy test immediately before beginning treatment, during treatment, and for 6 months after you have stopped therapy. Both male and female patients must use effective forms of birth control during treatment and for the 6 months after treatment is completed. Male patients should use a condom. If you are a female, you must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your health care provider about birth control for you and your partner.
Mental health problems and suicide. PEGINTRON® and PEGINTRON®/REBETOL® therapies may cause patients to develop mood or behavioral problems. These can include irritability (getting easily upset) and depression (feeling low, feeling bad about yourself, or feeling hopeless). Some patients may have aggressive behavior. Former drug addicts may fall back into drug addiction or overdose. Some patients think about hurting or killing themselves or other people and some have killed (suicide) or hurt themselves or others. You must tell your health care provider if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. You should tell your health care provider if you have ever been addicted to drugs or alcohol.
Heart problems. Some patients taking PEGINTRON® or PEGINTRON®/REBETOL® therapy may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks. Tell your health care provider if you have had any heart problems in the past.
Blood problems. PEGINTRON® and PEGINTRON®/REBETOL® therapies commonly lower two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously low levels. If your blood counts become very low, this could lead to infections or bleeding. REBETOL® therapy causes a decrease in the number of red blood cells you have (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. Talk with your health care provider before taking combination PEGINTRON®/REBETOL® therapy if you have or have ever had any cardiovascular problems.
Body organ problems. Certain symptoms like severe stomach pain may mean that your internal organs are being damaged. Cases of weakness, loss of coordination, and numbness due to stroke have been reported in patients taking PEGINTRON®, including patients with few or no reported risk factors for stroke.
New or worsening autoimmune disease. Some patients taking PEGINTRON® or PEGINTRON®/REBETOL® develop autoimmune diseases (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 patients who already have an autoimmune disease, the disease worsens on PEGINTRON® and PEGINTRON®/REBETOL® combination therapy.
Common but less serious side effects include:
Flu-like symptoms. Most patients who take PEGINTRON® or PEGINTRON®/REBETOL® therapy have "flu-like" symptoms (headache, muscle aches, tiredness, and fever). Some of these symptoms (fever, headache) usually lessen after the first few weeks of therapy. You can reduce some of these symptoms by injecting your PEGINTRON® dose at bedtime. Over-the-counter pain and fever reducers, such as acetaminophen or ibuprofen, can be used to prevent or reduce the fever and headache.
Extreme fatigue (tiredness). Many patients become extremely tired while on PEGINTRON® or PEGINTRON®/REBETOL® combination therapy.
Appetite problems. Nausea, loss of appetite, and weight loss occur commonly.
Thyroid problems. Some patients develop changes in the function of their thyroid. Symptoms of thyroid changes include the inability to concentrate, feeling cold or hot all the time, a change in your weight, and changes to your skin.
Blood sugar problems. Some patients develop problems with the way their body controls their blood sugar, and may develop high blood sugar or diabetes.
Skin reactions. Redness, swelling, and itching are common at the site of injection. If after several days these symptoms do not disappear contact your health care provider. You may get a rash during therapy. If this occurs, your health care provider may recommend medicine to treat the rash.
Hair thinning. Hair thinning is common during PEGINTRON® and PEGINTRON®/REBETOL® treatment. Hair loss stops and hair growth returns after therapy is stopped.
Effect on growth in children. Weight loss and slowed growth are common in children during treatment with PEGINTRON®/REBETOL®. Catch-up weight gain and some catch-up in growth occur after the end of treatment, but some children may not reach their pretreatment expected height.
These are not all of the side effects of PEGINTRON® or PEGINTRON®/REBETOL® combination therapy. Your health care provider or pharmacist can give you a more complete list.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
BE READY
A Few Simple Steps Can Help You with Your TreatmentOne of the best ways to succeed with your treatment is to know what to expect. Here are a few simple things you can do to BE READY:
Bedtime injection can help with side effects.
- If you inject around your bedtime, you may be able to sleep through the "flu-like" symptoms of therapy.
Eat regularly to stay strong.
- Make sure you are getting enough calories in your diet. If you are nauseous or don't have an appetite, try eating several smaller meals throughout the day, or eat healthy snacks.
Rest as much as you can.
- This is especially important during the first few weeks of therapy, when fever and headaches tend to be the worst.
Exercise lightly, but regularly, to help with fatigue.
- Be sure to pick exercise activities that are compatible with your level of fitness.
An over-the-counter pain reliever can help with "flu-like" symptoms.
- Take your pain reliever of choice before you inject, and consult your health care professional for appropriate timing. This can help prevent or relieve fever and headache. Be sure to consult with your doctor before taking any over-the-counter or prescription medicine.
Drink plenty of water or clear fluids every day.
- It is important to drink lots of water or clear juices without caffeine every day.
Your support from the Be In Charge® program can make a difference.
- Be In Charge® is a comprehensive support program sponsored by Schering Corporation with a variety of materials that can help you with your hepatitis C treatment. Becoming a member also gives you telephone access to nurse counselors who can help you with any questions you might have. If you haven't already enrolled, there should be an enrollment card in your patient starter kit. Or, if you'd like, you can enroll by calling 1-888-437-2608 or by visiting us online at www.beincharge.com.
Remember, it's important for you to stay on your medication for the entire time your doctor has prescribed. If you continue to have difficulty, tell your doctor or nurse counselor. In some cases, your doctor may delay or reduce your dose to help you through the side effects.
While you're undergoing therapy, work closely with your health care team. Share your progress, any side effects you may have, and ask questions. This is a very challenging time for you. Don't be embarrassed or afraid to ask your family or friends for help. Work with them to plan activities, get rest, and schedule daily exercise.
Please refer to the Medication Guide and/or REBETOL® Prescribing Information for more information.
