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Using PEGASYS
The Importance of Staying on Treatment Taking hepatitis C therapy requires your active participation and a strong commitment to finish what you've started. By following your doctor's exact instructions and taking your medication as directed, you are giving yourself the best chance of reducing the virus to a level where it cannot be seen in your blood (a virologic response). You may also be able to help improve the condition of your liver (a histologic response) by decreasing inflammation.

Of course, treatment may not always be easy. Sometimes people experience side effects that make taking medication difficult. Should you have any questions or concerns about side effects or your medication, be sure to talk with your doctor—and don't make any changes to your therapy without talking to your healthcare team first.

As you experience different feelings during treatment, it is good to have a place to record what you are feeling and when. When you feel good, you can look back on the times you wanted to quit and feel proud of your progress. You can also look back to see how you got through tough times before—and remember the good days that followed. You can use a paper notebook or journal, or use your online journal to record your thoughts and feelings alongside your appointments, medications, and other action items.

Your doctor or nurse may tell you that the way you feel while taking PEGASYS is "normal" or that the benefit of taking the medication should outweigh the side effects you are experiencing. But you are the one who will make the choice and commitment to continue your treatment. Make sure you have all the facts to help you get through it.

Remember that interferon alfa-2a in PEGASYS is similar to a substance that your body routinely makes—and your body makes more of it when you have an illness such as the flu. One of the reasons that you feel bad when you have the flu is that higher levels of interferon cause you to have certain symptoms, including fever, chills, headaches, and muscle and joint aches. But your body's interferon is fighting the influenza virus—so you "put up" with these symptoms to get rid of the virus.

In the case of the flu, you don't have any choice about "using" interferon—it is a natural part of your immune system. But your body's interferon is not as effective against the hepatitis C virus, so you have to take active treatment steps. As you might expect from this information about interferon, treatment with PEGASYS may cause many flu-like symptoms. For some people, these symptoms occur early in treatment but lessen as the weeks of therapy go on.

Here is the part that takes courage: you have to choose to continue on a course of treatment that may be causing you to feel "sick" in order to fight a virus that may not have been making you feel sick. In a sense, your treatment plan is like an investment in your health. Short-term losses can be unpleasant, but staying with your investment strategy may lead to long-term gains. There are no guarantees or easy answers, but hepatitis C can cause serious complications, especially if left untreated. Remember that the most serious effect of hepatitis C is on your liver—and damage to the liver can take time (even decades) to emerge.

Other common, but often manageable, side effects associated with PEGASYS and COPEGUS® (Ribavirin, USP) therapy include:

  • Fatigue
  • Upset stomach, nausea/vomiting
  • Difficulty in controlling blood sugar levels (which may lead to diabetes)
  • Skin reactions (such as rash, dry or itchy skin, temporary hair loss, or redness and swelling at the site of injection)
  • Temporary hair thinning
  • Trouble sleeping

Possible serious side effects, which your doctor or nurse can talk to you about, include mental health problems, blood problems, infections, and problems with your lungs, eyes, immune system, and heart. Your healthcare team may treat these side effects, change the amount of medication you take, or stop treatment with PEGASYS and COPEGUS.

A list of all side effects, including serious side effects, can be found here.

Safety Information

What is PEGASYS?

PEGASYS is a medicine used to treat some adults who have hepatitis C and signs of liver damage. PEGASYS works to reduce the amount of virus in your blood, helping your body fight the virus.

PEGASYS® (Peginterferon alfa-2a), like other alpha interferons, can cause fatal or make life-threatening problems worse (like mental, immune system, heart, liver, lung, intestinal and infections). Your doctor should monitor you during regular visits. If you show signs or symptoms of these conditions, your doctor may stop your medication. In most patients, these conditions get better after you stop taking PEGASYS (see medication guide for more information and warnings).

What is COPEGUS?

COPEGUS is a medicine that works by slowing down the growth of the virus. COPEGUS should be taken with PEGASYS to fight the virus. Do not take COPEGUS by itself.

COPEGUS® (Ribavirin, USP) can be extremely harmful and cause birth defects in an unborn baby. Female patients and the female partners of male patients should avoid getting pregnant. Ribavirin is known to cause anemia (low red blood cells), which can make heart disease worse. Also, ribavirin can harm your DNA and possibly cause cancer (see medication guide for more information and warnings).

Who should not take PEGASYS and COPEGUS?

Do not take PEGASYS alone or with COPEGUS if:

  • You are pregnant or your partner is pregnant
  • You or your partner plans to get pregnant during therapy or within 6 months after treatment ends
  • You are breastfeeding
  • You have hepatitis caused by your immune system (autoimmune hepatitis)
  • You have unstable or severe liver disease before or during treatment
  • You are allergic to alpha interferons or any of the ingredients in PEGASYS and COPEGUS
  • You have abnormal red blood cells (caused by conditions like sickle-cell anemia or thalassemia major)

What if I am pregnant or thinking about having a baby?

If you are a woman who could get pregnant, you must take pregnancy tests before, during and for 6 months after treatment ends to make sure you are not pregnant.

During treatment and for 6 months after treatment, female and male patients must:

  • Use two forms of birth control (one being a condom with spermicide)
  • Tell your doctor right away if you or your partner becomes pregnant. You or
    your doctor should also call the Ribavirin Pregnancy Registry at 1-800-593-2214

What medication should I avoid when I am taking PEGASYS and COPEGUS?

You should not take didanosine with COPEGUS. Talk to your doctor about all medications that you are taking.

What are the possible side effects?

The most common side effects of PEGASYS and COPEGUS are:

  • Flu-like symptoms (including fever, chills, muscle aches, joint pain, headaches)
  • Tiredness
  • Upset stomach (like nausea, taste changes, diarrhea)
  • Blood sugar problems (may lead to diabetes)
  • Skin problems (like rash, dry or itchy skin, redness and swelling at injection site)
  • Hair loss (temporary)
  • Trouble sleeping

The most serious side effects of PEGASYS and COPEGUS are:

  • Risks to pregnancies
  • Mental health problems (such as irritability, depression, anxiety, aggressiveness, trouble with drug addiction or overdose, thoughts about suicide, suicide attempts, suicide and thoughts about homicide)
  • Blood problems (like a drop in blood cells leading to increased risk for infections, bleeding and/or heart or circulatory problems)
  • Infections (which sometimes cause death)
  • Lung problems (like trouble breathing, pneumonia)
  • Eye problems (like blurred vision, loss of vision)
  • Autoimmune problems (such as psoriasis, thyroid problems)
  • Heart problems (including chest pain and, rarely, a heart attack)
  • Liver problems (rarely, liver function worsens). Patients with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment. Change in a blood test that measures liver inflammation occurs more often in patients with hepatitis B. If you have a rise in this blood test you may need to be watched more closely with additional blood tests.

Tell your doctor immediately if you think you or your partner may be pregnant or if any of these symptoms occur.

This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

Please see the medication guides and complete product information for PEGASYS and COPEGUS.

 

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