INDICATIONS

What is PEGASYS?

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

• Used alone or with COPEGUS® (ribavirin, USP) to treat adults and children 5 years and older who have chronic (lasting a long time) hepatitis C infection and certain types of liver problems, and have not taken alpha interferon.
• Used if you have chronic hepatitis C, you should not take PEGASYS by itself unless you are not able to take COPEGUS.
• Used to treat adults with chronic hepatitis B virus who show signs that the virus is damaging the liver.

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

IMPORTANT SAFETY INFORMATION

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?

• COPEGUS in combination with PEGASYS may cause birth defects or death of your unborn baby.
• PEGASYS therapy may cause you to develop mood or behavioral problems.
• Some people who take PEGASYS alone or in combination with COPEGUS may get heart problems.
• Stroke or symptoms of a stroke.
• Some people taking PEGASYS develop new or worsening autoimmune problems.
• Some people who take PEGASYS may get an infection.

PEGASYS alone or in combination with COPEGUS 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.

Do not take PEGASYS if you:

• Have certain other liver problems.
• Have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis).
• Have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS.

Do not take PEGASYS in combination with COPEGUS if you:

• Are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment.
• Are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with COPEGUS or during the 6 months after your treatment has ended.
• Have certain blood disorders such as thalassemia major or sickle-cell anemia.
• Take didanosine (Videx^® or Videx^® EC).

Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol.

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.

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

PEGASYS can cause serious side effects including: blood problems, thyroid problems, blood sugar problems, serious eye problems, serious liver problems, worsening of liver problems including liver failure and death, lung problems, inflammation of your pancreas, inflammation of your intestines, serious allergic reactions and skin reactions, effect on growth in children, and nerve problems.

The most common, but less serious, side effects of PEGASYS include: flu-like symptoms, tiredness and weakness, stomach problems, loss of appetite, skin reactions, hair thinning, trouble sleeping.

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

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. The Access Solutions logo is a registered trademark of Genentech, Inc.