PEGASYS and chronic hepatitis C

Will PEGASYS treatment for chronic hepatitis C work for me?

A number of factors may affect treatment response

The goal of chronic hepatitis C treatment is SVR, or sustained virologic response. SVR means that the chronic hepatitis C virus can no longer be detected in your blood 6 months after the end of treatment.

Everyone is different, and there are different treatment regimens with PEGASYS. The way you respond to a treatment regimen can be different from the way someone else does.

Speak with your healthcare provider about factors that can affect your response to treatment. Only your healthcare provider can decide if treatment with PEGASYS is right for you.

Learn more about results in patients with chronic hepatitis C who are treated with PEGASYS.

Learn more about the safety of PEGASYS when used in patients with chronic hepatitis C.

Next: Dual Therapy (PEGASYS+Ribavirin): Efficacy and Safety for Chronic Hepatitis C

INDICATIONS

What is PEGASYS?

PEGASYS® (peginterferon alfa-2a) is a prescription medication that is:

It is not known if PEGASYS is safe and will work in children under 5 years of age.

IMPORTANT SAFETY INFORMATION

Boxed WARNINGS

PEGASYS, like other alpha interferons, may cause or worsen fatal or life-threatening problems (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 many patients, but not all, these conditions get better after they stop taking PEGASYS (see the Medication Guide for more information and Warnings).

Ribavirin, including COPEGUS®, can cause birth defects and/or death to 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 (see the COPEGUS Medication Guide for more information and Warnings).

What is the most important information I should know about PEGASYS alone or in combination with ribavirin?

  1. Ribavirin in combination with PEGASYS may cause birth defects or death of your unborn baby. Females must have pregnancy tests before, during and for 6 months after PEGASYS/ribavirin combination therapy. During treatment and for 6 months after treatment, female and male patients must:
    • use 2 forms of birth control, one being a condom with spermicide
    • inform their healthcare provider if pregnancy occurs while taking PEGASYS/ribavirin or within 6 months after stopping PEGASYS/ribavirin therapy. Patients or their healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1-800-593-2214
  2. Mental health problems and suicide. PEGASYS therapy may cause you to develop mood or behavioral problems including:
    • irritability (getting upset easily)
    • depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety
    • aggressive behavior
    • former drug addicts may fall back into drug addiction or overdose
    • thoughts of hurting yourself or others, or suicide
  3. Heart problems. Some people who take PEGASYS alone or in combination with ribavirin may get heart problems, including:
    • high blood pressure
    • fast heart rate or abnormal heart beat
    • chest pain
    • heart attacks
  4. Stroke or symptoms of a stroke. Symptoms may include weakness, loss of coordination, and numbness.
  5. New or worsening autoimmune problems. Some people taking PEGASYS develop autoimmune problems (a condition where the body’s immune cells attack other cells or organs in the body), such as rheumatoid arthritis, lupus, and psoriasis.
  6. Infections. Some people who take PEGASYS may get an infection. Symptoms may include:
    • fever
    • chills
    • burning and painful urination
    • urinating often
    • coughing up yellow or pink mucus (phlegm)

PEGASYS alone or in combination with ribavirin can cause serious side effects. Some of these side effects may cause death. Tell your healthcare provider right away if you have any of these symptoms while taking PEGASYS.

Who should not take PEGASYS?

Do not take PEGASYS if you:

Do not take PEGASYS in combination with ribavirin if you:

Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death.

Before taking PEGASYS, tell your healthcare provider about all your medical conditions or problems, and if you are pregnant or breastfeeding, or plan to become pregnant or breast feed during treatment with PEGASYS.

What should I tell my healthcare provider before taking PEGASYS?

Before taking PEGASYS, tell your healthcare provider if you have:

What medications should I tell my healthcare provider I am taking before starting therapy with PEGASYS?

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

What should I avoid while taking PEGASYS, or PEGASYS with ribavirin?

What are the possible side effects of PEGASYS?

PEGASYS can cause serious side effects including:

Tell your healthcare provider right away if you believe you may have any of the side effects listed above.

The most common, but less serious, side effects of PEGASYS include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all of the side effects of PEGASYS. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see PEGASYS full Prescribing Information and Medication Guide, including Boxed WARNINGS, for additional Important Safety Information.

PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche Inc. All other brands for listed products are trademarks or registered trademarks (as indicated) of their respective owners and are not trademarks of Genentech, Inc. or Hoffmann-La Roche Inc.