What is PEGASYS (Peginterferon alfa-2a)?
PEGASYS is a drug used to treat adults who have a lasting (chronic) infection with hepatitis C virus or hepatitis B virus and who show signs that the virus is damaging the liver. Patients with hepatitis have the virus in their blood and in their liver. PEGASYS reduces the amount of hepatitis C virus in the body and helps the body’s immune system fight the virus. The drug COPEGUS are tablets that may be taken with PEGASYS to help fight the virus infection. Do not take COPEGUS by itself.
What is the most important information I should know about PEGASYS?
- PEGASYS, taken alone or in combination with COPEGUS, is a treatment for some people who are infected with hepatitis C virus. PEGASYS taken alone is a treatment for some people who are infected with the hepatitis B virus. However, PEGASYS and COPEGUS can have serious side effects that may cause death in rare cases. Before starting PEGASYS therapy, you should talk with your healthcare provider about the possible benefits and the possible side effects of treatment, to decide if either of these treatments is right for you. If you begin treatment you will need to see your healthcare provider regularly for examinations and blood tests to make sure your treatment is working and to check for side effects
The most serious possible side effects of PEGASYS taken alone or in combination with COPEGUS include:
- Risks to Pregnancy: Taking PEGASYS in combination with COPEGUS tablets can cause death, serious birth defects or other harm to your unborn child. Therefore, if you are pregnant or your partner is pregnant or plans to become pregnant, do not take PEGASYS/COPEGUS combination therapy. Female patients and female partners of male patients being treated with PEGASYS/COPEGUS combination therapy must not become pregnant during treatment and for 6 months after treatment has stopped. During this time, you must have pregnancy tests that show you are not pregnant. You must also use two effective forms of birth control during therapy and for 6 months after stopping therapy. Male patients should use a condom with spermicide as one of the two forms. 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 healthcare provider about birth control for you and your partner.
- Mental health problems: PEGASYS may cause some patients to develop mood or behavioral problems. Signs of these problems include irritability (getting easily upset), depression (feeling low, feeling bad about yourself or feeling hopeless), and anxiety. Some patients may have aggressive behavior. Some patients may develop thoughts about ending their lives (suicidal thoughts) and may attempt to do so. A few patients have even ended their lives. Former drug addicts may fall back into drug addiction or overdose. You must tell your healthcare provider if you are being treated for a mental illness or have a history of mental illness or if you are or have ever been addicted to drugs or alcohol. Call your healthcare provider immediately if you develop any of these problems while on PEGASYS treatment
-
Blood problems: Many patients taking PEGASYS have had a drop in the number of their white blood cells and their platelets. If the numbers of these blood cells are too low, you could be at risk for serious infections or bleeding.
COPEGUS causes a decrease in the number of your red blood cells (anemia). This can be dangerous, especially for patients who already have heart or circulatory (cardiovascular) problems. If you have or have ever had any cardiovascular problems, talk with your healthcare provider before taking the combination of PEGASYS and COPEGUS -
Liver problems: Infrequently, some patients with hepatitis C and liver scarring can develop sudden severe worsening (failure) of their liver disease while taking PEGASYS. Patients infected with both the hepatitis C virus and HIV can have an increased chance of having liver failure during PEGASYS treatment.
Some patients taking PEGASYS for hepatitis B have had a rise in a blood test that measures liver inflammation. If you have a rise in this blood test, your liver may need to be watched more closely with additional blood tests. - Infections: Some patients taking interferon have had serious infections. Sometimes these infections have been fatal. If you develop a fever that does not go away or gets higher, call your healthcare provider right away. Your healthcare provider will need to examine you to rule out your having a serious infection.
- Body organ problems: Some patients may experience lung problems (such as difficulty breathing or pneumonia) and eye problems that can cause blurred vision or loss of your vision.
- Autoimmune problems: Some patients may develop a disease where the body's own immune system begins to attack itself (autoimmune disease) while on PEGASYS therapy. These diseases can include psoriasis or thyroid problems. In some patients who already have an autoimmune disease, the disease may worsen while on PEGASYS therapy.
- Heart problems: PEGASYS may cause some patients to experience chest pain, and very rarely a heart attack. Patients who already have heart disease could be at greatest risk. Tell your healthcare provider if you have or have had a heart problem in the past.
- Common, but less serious, side effects include:
- Flu-like symptoms
- Extreme fatigue (tiredness)
- Upset stomach
- Skin reactions
- Hair thinning
- Blood sugar problems
- Trouble sleeping
How should I take PEGASYS or PEGASYS with COPEGUS?
- PEGASYS is given by injection under the skin (subcutaneous injection). PEGASYS comes in two different forms (a liquid in a single use vial and a liquid in a prefilled syringe). Your healthcare provider will determine which is best for you. Your healthcare provider will also decide whether you will take PEGASYS alone or with COPEGUS. Your dose of PEGASYS is given as a single injection once per week. At some point, your healthcare provider may change your dose of PEGASYS or COPEGUS. Do not change your dose unless your healthcare provider tells you to change it. It is important that you take PEGASYS and COPEGUS exactly as your healthcare provider tells you. Once you start treatment with PEGASYS, do not switch to another brand of interferon without talking to your healthcare provider. Other interferons may not have the same effect on the treatment of your disease. Switching brands will also require a change in your dose.
- Take your prescribed dose of PEGASYS once a week, on the same day of each week and at approximately the same time. Your total dose of COPEGUS tablets should be divided so you take it twice a day with food (breakfast and dinner). Taking half your dose of COPEGUS in the morning and the other half at night will keep the medicine in your body at a steady level. Do not take more than your prescribed dose of PEGASYS or COPEGUS.
- Your healthcare provider will train you and/or the person that will be giving you the PEGASYS injections on the proper way to give injections. Whether you give yourself the injection or another person gives the injection to you, it is important that you are comfortable with preparing and injecting a dose of PEGASYS,
- If you miss a dose and 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 miss a dose of COPEGUS, take the missed dose as soon as you remember during the same day. Do not take 2 doses too close together in time. If it is late in the day, wait until the next day and go back on schedule. Do not double the next dose.
- 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 take blood for testing. You must get regular blood tests to help your healthcare provider check how the treatment is working and to check for side effects.
Important Safety Information
- If you are pregnant do not start taking or continue taking COPEGUS in combination with PEGASYS.
- Avoid becoming pregnant while taking PEGASYS, alone or in combination with COPEGUS. PEGASYS, alone or in combination with COPEGUS, may harm your unborn child (death or serious birth defects) or cause you to lose your baby (miscarry).
- Do not breast-feed your baby while on PEGASYS, alone or in combination with COPEGUS.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking PEGASYS?
Tell your healthcare provider before you start taking PEGASYS:
- History of or current severe mental illness (such as depression or anxiety)
- History of drug or alcohol addiction or abuse
- History of heart disease or previous heart attack
- History of cancer
- Autoimmune disease (where the body’s immune system attacks the body’s own cells), such as psoriasis (a skin disease), systemic lupus erythematosus, rheumatoid arthritis
- Kidney problems
- Blood disorders
- You take a medicine called theophylline
- Diabetes (high blood sugar)
- Problems with the thyroid gland
- Liver problems, other than hepatitis C or hepatitis B
- Colitis (an inflammation of the bowels)
General information about PEGASYS
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns or questions about PEGASYS, contact your healthcare provider. Do not use PEGASYS for a condition or person other than that for which it is prescribed. If you want to know more about PEGASYS, your healthcare provider or pharmacist will be able to provide you with detailed information that is written for health-care providers.
What are the ingredients in PEGASYS?
Active ingredient: Peginterferon Alfa-2A
Other ingredient: