Peginterferon alfa-2a

What it is used for

PEGASYS is an inducer of the innate immune response indicated for the treatment of Chronic Hepatitis C (CHC) Adult Patients: In combination therapy with other hepatitis C virus drugs for adults with compensated liver disease. PEGASYS monotherapy is indicated only if patient has contraindication or significant intolerance to other HCV drugs.

Pediatric Patients: In combination with ribavirin for pediatric patients 5 years of age and older with compensated liver disease Chronic Hepatitis B (CHB) Adult Patients: Treatment of adults with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) infection who have compensated liver disease and evidence of viral replication and liver inflammation Pediatric Patients: Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive CHB and evidence of viral replication and elevations in serum alanine aminotransferase (ALT) 1.1 Chronic Hepatitis C (CHC) Adult Patients: PEGASYS, as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is indicated for the treatment of adults with CHC and compensated liver disease.

For information about the safe and effective use of other HCV antiviral drugs to be used in combination with PEGASYS, refer to their prescribing information. PEGASYS monotherapy is only indicated for the treatment of patients with CHC and compensated liver disease if there are contraindications or significant intolerance to other HCV antiviral drugs.

Pediatric Patients: PEGASYS in combination with ribavirin is indicated for the treatment of pediatric patients 5 years of age and older with CHC and compensated liver disease. Limitations of Use: PEGASYS alone or in combination with ribavirin without additional HCV antiviral drugs is not recommended for treatment of patients with CHC who previously failed therapy with an interferon-alfa.

PEGASYS is not recommended for treatment of patients with CHC who have had solid organ transplantation. 1.2 Chronic Hepatitis B (CHB) Adult Patients: PEGASYS is indicated for the treatment of adults with HBeAg-positive and HBeAg-negative CHB infection who have compensated liver disease and evidence of viral replication and liver inflammation.

Pediatric Patients: PEGASYS is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic pediatric patients 3 years of age and older with evidence of viral replication and elevations in serum alanine aminotransferase (ALT).

The most important thing to know

Ribavirin in combination with PEGASYS may cause birth defects or death of your unborn baby.If you are pregnant or your sexual partner is pregnant or plans to become pregnant,

How to take it

PEGASYS is given by injection under the skin (subcutaneous injection). Your healthcare provider will decide on your dose of PEGASYS and when you will take it. PEGASYS is usually injected 1 time each week. For children 3 years of age and older infected with hepatitis B virus or 5 years of age and older infected with hepatitis C virus, your healthcare provider will prescribe the dose of PEGASYS based on your child's height and weight.

If your healthcare provider decides that you or a caregiver can inject PEGASYS, inject it exactly as prescribed. See the Instructions for Use that comes with your PEGASYS for detailed instructions about how to prepare and inject a dose of PEGASYS. Your healthcare provider may decrease your dose, temporarily stop, or permanently stop your treatment with PEGASYS if you develop certain side effects.

Do not change your dose unless your healthcare provider tells you to change it. Do not switch to another brand of interferon without talking to your healthcare provider. Take your prescribed dose of PEGASYS 1 time each week, on the same day of each week and at approximately the same time. Do not take more than your prescribed dose.

PEGASYS comes as a liquid: in a single-dose vial in a single-dose prefilled syringe Your healthcare provider will decide which one is best for you. Your healthcare provider should show you how to prepare and measure, and injectyour dose of PEGASYS before you use the single-dose vial or single-dose prefilled syringe for the first time.

When you get your prescription from the pharmacy, ask your pharmacist for the syringe and needle that you need to use to prepare and inject a dose of PEGASYS from the single-dose vial. If you will be injecting a child with PEGASYS, you will need a special syringe called a tuberculin syringe, which can measure doses of PEGASYS that are 1 milliliter (1mL) or less.

Do not reuse PEGASYS single-dose vials, single-dose prefilled syringes and needles. If you miss your dose: If you remember within 2 days of when you should have taken PEGASYS, give yourself an injection of PEGASYS as soon as you remember. Take your next dose on the day you would usually take it. If more than 2 days have passed, ask your healthcare provider what you should do.

If you take more than the prescribed amount of PEGASYS, call your healthcare provider right away. Your healthcare provider may want to examine you and do blood tests.

Side effects, and when to stop

" What is PEGASYS? PEGASYS is a prescription medicine that is: used with other hepatitis C virus (HCV) antiviral medicines to treat adults who have chronic (lasting a long time) hepatitis C infection and compensated liver disease. used alone to treat adults with chronic hepatitis C (CHC) and compensated liver disease, and who are not able to take other HCV antiviral medicines.

used with ribavirin to treat children 5 years of age and older who have CHC and compensated liver disease. PEGASYS should not be used alone or with ribavirin, without taking other HCV antiviral medicines, to treat people with CHC who have taken interferon-alfa and it did not work. PEGASYS should not be used to treat people with CHC who have received an organ transplant.

PEGASYS is a prescription medicine that is: used alone to treat adults and children 3 years and older with chronic hepatitis B (CHB) virus who show signs that the virus is damaging the liver It is not known if PEGASYS is safe and effective in: children with CHC under 5 years of age or children with CHB under 3 years of age.

people with Hepatitis B virus (HBV) who also have HCV or HIV infection people with HCV who also have HBV, or HIV infection and their CD4+ cell count is less than 100 cells/mm 3 Who should not take PEGASYS? Do not take PEGASYS if you: have had a serious allergic reaction to another alpha-interferon medicine or to any of the ingredients in PEGASYS.

Symptoms of a serious allergic reaction to alpha-interferon may include itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain. See the end of this Medication Guide for a list of the ingredients in PEGASYS. have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) have certain other liver problems Do notgive PEGASYS to a baby under 1 year of age.

PEGASYS contains benzyl alcohol. Benzyl alcohol can cause nervous system problems and other problems which may lead to death. Do nottake PEGASYS in combination with ribavirin if you: are pregnant, or plan to get pregnant during treatment, or during the 6 months after treatment are a male with a female sexual partner who is pregnant or plans to become pregnant at any time during treatment with ribavirin or during the 6 months after your treatment has ended.

Talk to your healthcare provider before taking PEGASYS if you have any of these conditions. Before taking PEGASYS tell your healthcare provider about all of your medical conditions, including if you: have or ever had any problems with your heart, including heart attack have high blood pressure have liver problems (other than hepatitis B or C) have lung problems have thyroid problems have diabetes have colitis (inflammation of your intestine) have any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis have or ever had low blood cell counts have cancer have or had blood disorders (bleeding problems or a blood clot, thalassemia major or sickle-cell anemia) hepatitis B or C infection have Human Immunodeficiency Virus -1 (HIV-1) infection have kidney problems have high blood triglyceride levels (fat in your blood) have had an organ transplant have ever been addicted to drugs or alcohol are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior.

are pregnant or plan to become pregnant. PEGASYS can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with PEGASYS. if you take PEGASYS in combination with ribavirin. ​Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with PEGASYS.

You should use effective birth control (contraception) during treatment with PEGASYS. are breastfeedin

Who should not take it

do not take PEGASYS and ribavirin combination therapy. You or your sexual partner should not become pregnant during treatment with PEGASYS and ribavirin combination therapy and for 6 months after treatment is over. You must use 2 effective forms of birth control, one of which should be a condom with spermicide during treatment with PEGASYS and ribavirin combination therapy, and for the 6 months after the last dose.

Females must have a pregnancy test before starting PEGASYS and ribavirin combination therapy, every month while being treated, and every month for the 6 months after stopping treatment with PEGASYS and ribavirin combination therapy. If you or your female sexual partner becomes pregnant during treatment with PEGASYS and ribavirin or within 6 months after you stop taking PEGASYS and ribavirin,tell your healthcare provider right away.

You or your healthcare provider should contact the ribavirin Pregnancy Registry by calling 1-800-593-2214. The ribavirin Pregnancy Registry collects information about the health of you and your baby if you take PEGASYS and ribavirin during pregnancy or if you become pregnant within 6 months after you stop taking PEGASYS and ribavirin.

Mental health problems and suicide. PEGASYS 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 Heart problems.PEGASYS may cause heart problems, including: high blood pressure fast heart rate or abnormal heart beat chest pain heart attacks trouble breathing 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 PEGASYS develop autoimmune problems (a condition where the body's immune cells attack other cells or organs in the body), such as rheumatoid arthritis, systemic lupus erythematosus, and psoriasis.

In some people who already have an autoimmune problem, it may get worse during your treatment with PEGASYS. Infections. Symptoms may include: fever chills burning and painful urination urinating often coughing up yellow or pink mucus (phlegm) Before and during treatment with PEGASYS you will need to see your healthcare provider regularly and have blood tests to make sure that your treatment is working and to check for side effects.

PEGASYS 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 during treatment with PEGASYS. For more information about side effects, see "

What to avoid

Avoid drinking alcohol. This may make your liver disease worse. Avoid driving or operating machinery if you become dizzy, confused, very sleepy, or tired during treatment with PEGASYS. What are the possible side effects of PEGASYS? PEGASYS can cause serious side effects including: Blood problems.PEGASYS can affect your bone marrow and cause low red blood cell, low white blood cell and low platelet counts.

These blood counts may fall to dangerously low levels. If your blood cell counts become very low, you can get anemia, infections or have problems with bleeding and bruising. Thyroid problems. Symptoms of thyroid changes include feeling cold or hot all the time, a change in your weight, and changes to your skin, trouble concentrating.

Blood sugar problems. PEGASYS may cause low blood sugar (hypoglycemia), high blood sugar (hyperglycemia) or diabetes. If you have high blood sugar or diabetes before starting PEGASYS, talk to your healthcare provider before you take PEGASYS. If you develop high blood sugar or diabetes during treatment with PEGASYS, your healthcare provider may tell you to stop PEGASYS and prescribe a different medicine for you.

Symptoms of low blood sugar may include: feeling faint headaches, sweating anxiousness confusion weakness Symptoms of high blood sugar or diabetes may include: increased thirst tiredness urinating more often than normal increased appetite weight loss your breath smells like fruit Serious eye problems. PEGASYS may cause eye problems that may lead to vision loss or blindness.

You should have an eye exam before you start taking PEGASYS. If you have eye problems or have had them in the past, you may need eye exams during treatment with PEGASYS. Tell your healthcare provider or eye doctor right away if you have any vision changes during treatment with PEGASYS. Serious liver problems,worsening of liver problems including liver failure and death.

Symptoms may include: nausea loss of appetite tiredness diarrhea yellowing of your skin or the white part of your eyes bleeding more easily than normal swelling of your stomach area (abdomen) confusion sleepiness you cannot be awakened (coma) Lung problems, including: trouble breathing pneumonia inflammation of lung tissue new or worse high blood pressure of the lungs (pulmonary hypertension).

This can be severe and may lead to death. You may need to have a chest X-ray or other tests if you develop fever, cough, shortness of breath or other symptoms of a lung problem during treatment with PEGASYS. Inflammation of your intestines (colitis). Symptoms of inflammation of your intestines (colitis) may include: severe stomach area (abdomen) pain fever bloody diarrhea or blood bowel movements Inflammation of your pancreas (pancreatitis).

Symptoms of inflammation of your pancreas (pancreatitis) may include: severe stomach (abdomen) pain severe back pain nausea vomiting fever Serious allergic reactions and skin reactions. Get medical help right away if you get any of the following symptoms: itching swelling of your face, eyes, lips, tongue, or throat trouble breathing skin rash, hives, sores in your mouth, or your skin blisters and peels chest pain feeling faint Effect on growth in children.

A delay in height increase or weight gain has happened in children with CHC during treatment with PEGASYS and ribavirin, and in children with CHB during treatment with PEGASYS. Some children may not reach the height and weight they were expected to have before treatment after they stop treatment with PEGASYS. Talk to your healthcare provider if you are concerned about your child’s growth during treatment or after stopping treatment with PEGASYS.

Talk to your healthcare provider if you are concerned about your child's growth during treatment with PEGASYS. Nerve problems. People who take PEGASYS or other alfa interferon products with telbivudine (Tyzeka) for hepatitis B can develop nerve problems such a

Storing it

Store PEGASYS single-dose vials and single-dose prefilled syringes in a refrigerator at 36°F to 46°F (2°C to 8°C). Do notleave PEGASYS out of the refrigerator for more than 24 hours. Do notfreeze or shake PEGASYS. Protect PEGASYS from light. Keep PEGASYS and all medicines out of the reach of children.