Peginterferon Alfa-2a

Generic Name: Peginterferon Alfa-2a (peg-IN-ter-FEER-on AL-fa)Brand Name: Pegasys

Peginterferon Alfa-2a may cause or worsen fatal or life-threatening medical conditions, including mental or mood problems (eg, depression, suicidal thoughts or behaviors), immune system problems (eg, lupus, rheumatoid arthritis), blood vessel problems (eg, ischemia), and infection. These problems usually go away after stopping Peginterferon Alfa-2a , but not always. If you have a history of any of these problems or develop them while using Peginterferon Alfa-2a , tell your doctor immediately.

Peginterferon Alfa-2a is sometimes used with another medicine called ribavirin. Ribavirin may cause birth defects or fetal death and must not be used during pregnancy. Women who use ribavirin and female partners of men who use ribavirin and are of childbearing potential must avoid becoming pregnant. Two forms of effective birth control must be used during treatment with ribavirin and for 6 months after ribavirin treatment is stopped. Ribavirin can cause a certain blood disorder called hemolytic anemia, which may worsen existing heart disease. Ribavirin may also potentially cause cancer. Tell your doctor immediately if any serious symptoms or side effects occur.

Peginterferon Alfa-2a is used for:

Treating chronic hepatitis C infection in patients who have controlled liver disease and have not been previously treated with interferon alfa. Peginterferon Alfa-2a is used either alone or in combination with other medicines. It is also used to treat certain patients with hepatitis B. It may also be used for other conditions as determined by your doctor.

Peginterferon Alfa-2a is an interferon. It works by reducing the amount of hepatitis C virus in the body. It also helps the immune system fight the virus.

Do NOT use Peginterferon Alfa-2a if:

  • you are allergic to any ingredient in Peginterferon Alfa-2a or to another alpha interferon
  • you are pregnant or breast-feeding
  • you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or you have unstable or severe liver disease
  • you have certain blood problems (eg, sickle cell anemia, thalassemia major)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Peginterferon Alfa-2a :

Some medical conditions may interact with Peginterferon Alfa-2a . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems or heart attack, kidney problems, bone marrow problems, blood or bleeding disorders, stroke, thyroid problems, lung problems (eg, asthma, pneumonia), stomach or intestinal problems (eg, colitis, blood in the stools or vomit), pancreas problems, or eye problems
  • if you have a history of autoimmune disease (eg, psoriasis, lupus, rheumatoid arthritis), cancer, diabetes, high cholesterol or lipids in your blood, HIV infection, liver problems other than hepatitis C (eg, cirrhosis, hepatitis B infection), organ transplant, or seizures
  • if you have a history of mental or mood problems (eg, depression, anxiety), suicidal thoughts or behaviors, or alcohol or other substance abuse

Some MEDICINES MAY INTERACT with Peginterferon Alfa-2a . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Nucleoside reverse transcriptase inhibitors (eg, zidovudine) because the risk of anemia may be increased
  • Methadone or theophylline because the risk of their side effects may be increased by Peginterferon Alfa-2a

This may not be a complete list of all interactions that may occur. Ask your health care provider if Peginterferon Alfa-2a may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Peginterferon Alfa-2a :

Use Peginterferon Alfa-2a as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Peginterferon Alfa-2a comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Peginterferon Alfa-2a refilled.
  • Peginterferon Alfa-2a is sometimes used with another medicine called ribavirin, which comes with its own Medication Guide. If you are also using ribavirin, be sure to read its Medication Guide carefully each time you get it filled.
  • Peginterferon Alfa-2a is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Peginterferon Alfa-2a at home, a health care provider will teach you how to use it. Be sure you understand how to use Peginterferon Alfa-2a . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use another brand of Peginterferon Alfa-2a or change your dose without talking with your doctor.
  • Drinking extra fluids while you are taking Peginterferon Alfa-2a is recommended. Check with your doctor for instructions.
  • Do not use Peginterferon Alfa-2a if the expiration date has passed, if it contains particles or is discolored, or if the vial or prefilled syringe is cracked or damaged.
  • Do not shake Peginterferon Alfa-2a .
  • Be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. Carefully check that you have drawn the correct dose before administration.
  • Each vial or prefilled syringe is for a single use only. Throw away any unused medicine.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Use Peginterferon Alfa-2a on a regular schedule to get the most benefit from it. Using Peginterferon Alfa-2a at the same time each week will help you remember to use it.
  • Continue to use Peginterferon Alfa-2a even if you feel well. Do not miss any doses.
  • If you miss a dose of Peginterferon Alfa-2a and you remember within 2 days of the missed dose, use it as soon as possible and go back to your regular dosing schedule. If more than 2 days have passed, contact your doctor for instructions. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Peginterferon Alfa-2a .

Important safety information:

  • Peginterferon Alfa-2a may cause drowsiness, dizziness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Peginterferon Alfa-2a with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Peginterferon Alfa-2a may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Peginterferon Alfa-2a may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Peginterferon Alfa-2a is not a cure for hepatitis C infection and may not prevent you from spreading hepatitis C infection to others.
  • Peginterferon Alfa-2a may cause high or low blood sugar (eg, thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, fruity breath odor, fast heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). If these symptoms occur, tell your doctor immediately.
  • Tell your doctor or dentist that you take Peginterferon Alfa-2a before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including eye exams; pregnancy tests; blood counts; blood pressure; heart, liver, kidney, thyroid, and lung function tests; blood glucose levels; and other blood tests, may be performed while you use Peginterferon Alfa-2a . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Peginterferon Alfa-2a with caution in the ELDERLY; they may be more sensitive to its effects, especially heart effects, nervous system effects, and systemic side effects (eg, flu-like symptoms).
  • Peginterferon Alfa-2a has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.
  • Peginterferon Alfa-2a should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Peginterferon Alfa-2a . If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Peginterferon Alfa-2a while you are pregnant. Use of Peginterferon Alfa-2a with ribavirin during pregnancy has resulted in birth defects and fetal death. It is not known if Peginterferon Alfa-2a is found in breast milk. Do not breast-feed while taking Peginterferon Alfa-2a .

Possible side effects of Peginterferon Alfa-2a :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; dry mouth; dry or irritated skin; hair thinning; headache; loss of appetite; mild flu-like symptoms (fever, chills, muscle aches, or joint pain); nausea; pain, redness, itching, or swelling at the injection site; taste changes; temporary hair loss; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); back pain; blisters or sores in the eyes, nose, or mouth; bloody or black, tarry stools; burning, numbness, or tingling in the arms, hands, legs, or feet; chest pain; confusion; dark urine, change in the amount of urine produced, or painful urination; difficulty hearing or hearing loss; eye pain or redness; fast, slow, or irregular heartbeat; one-sided weakness; pale stools; persistent or severe diarrhea, nausea, stomach pain, or vomiting; persistent or severe fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe or unusual tiredness or weakness; slurred speech; stomach bloating; sudden leg pain; sudden severe dizziness, fainting, headache, or vomiting; sudden shortness of breath; unusual bruising or bleeding; unusual mental or mood changes (eg, anxiety, aggressive or unusual behavior, depression, hallucinations, irritability, suicidal thoughts or behavior); unusually increased thirst; vision loss or other vision changes; weight loss; worsening psoriasis; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Peginterferon Alfa-2a :

Store Peginterferon Alfa-2a in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not leave out of the refrigerator for more than 24 hours. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Peginterferon Alfa-2a out of the reach of children and away from pets.

General information:

  • If you have any questions about Peginterferon Alfa-2a , please talk with your doctor, pharmacist, or other health care provider.
  • Peginterferon Alfa-2a is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Peginterferon Alfa-2a . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Peginterferon Alfa-2a Professional Patient Advice (Wolters Kluwer)
  • Peginterferon alfa-2a Detailed Consumer Information (PDR)
  • peginterferon alfa-2a Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
  • Pegasys Prescribing Information (FDA)
  • Pegasys Consumer Overview