Generic Name: peginterferon alfa-2a (peg-IN-ter-FEER-on AL-fa)
Brand Name: Pegasys
Pegasys may cause or worsen fatal or life-threatening medical conditions, including mental or mood problems (eg, depression, suicidal thoughts or behaviors), autoimmune diseases (eg, lupus, rheumatoid arthritis), blood vessel problems (eg, ischemia), and infection. These problems usually go away after stopping Pegasys, but not always. Your doctor will monitor you for these conditions. Be sure to keep all doctor and laboratory appointments. If you have a history of any of these problems or develop them while using Pegasys, tell your doctor immediately.
Pegasys 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 sexual partners of men who use ribavirin and are of childbearing potential must avoid becoming pregnant. They must also
- have a negative pregnancy test immediately before therapy with Pegasys is started.
- avoid becoming pregnant during therapy with Pegasys or within the first 6 months after Pegasys is stopped.
Two forms of effective birth control must be used during treatment with ribavirin and for 6 months after ribavirin treatment is stopped. Discuss any questions or concerns with your doctor.
Ribavirin can also cause a certain blood disorder called hemolytic anemia, which may worsen existing heart disease. Tell your doctor immediately if any serious symptoms or side effects occur.
Pegasys is used for:
Treating chronic hepatitis C infection in patients who have controlled liver disease and have not been previously treated with interferon alfa. Pegasys 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.
Pegasys is an interferon. It works by reducing the amount of hepatitis virus in the body. It also helps the immune system fight the virus.
Do NOT use Pegasys if:
- you are allergic to any ingredient in Pegasys or to another alpha interferon
- you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or you have unstable or severe liver disease
- you have uncontrolled thyroid or blood sugar problems
- you are taking telbivudine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Pegasys:
Some medical conditions may interact with Pegasys. 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 a heart attack, high blood pressure, kidney problems or if you are on dialysis, bone marrow problems (eg, low white blood cell levels, low platelet levels), blood or bleeding disorders, stroke, thyroid problems, lung or breathing problems (eg, asthma, pneumonia), stomach or bowel problems (eg, colitis, blood in the stools or vomit), pancreas problems, or eye or vision problems
- if you have a history of autoimmune disease (eg, psoriasis, lupus, rheumatoid arthritis), cancer, diabetes, high cholesterol or triglycerides in your blood, HIV infection, liver problems other than hepatitis (eg, cirrhosis), 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
- if you are taking azathioprine or medicines for HIV
Some MEDICINES MAY INTERACT with Pegasys. 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
- Telbivudine because the risk of burning, numbness, or tingling in the arms or legs may be increased
- Methadone or theophylline because the risk of their side effects may be increased by Pegasys
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pegasys 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 Pegasys:
Use Pegasys as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Pegasys comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pegasys refilled.
- Pegasys 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.
- Pegasys is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Pegasys at home, a health care provider will teach you how to use it. Be sure you understand how to use Pegasys. 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 Pegasys or change your dose without talking with your doctor.
- Drinking extra fluids while you are taking Pegasys is recommended. Check with your doctor for instructions.
- Do not use Pegasys 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 Pegasys.
- 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 Pegasys on a regular schedule to get the most benefit from it. Using Pegasys at the same time each week will help you remember to use it.
- Continue to use Pegasys even if you feel well. Do not miss any doses.
- If you miss a dose of Pegasys 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 Pegasys.
Important safety information:
- Pegasys may cause drowsiness, dizziness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Pegasys with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
- Pegasys 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.
- Pegasys 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.
- Pegasys is not a cure for hepatitis C infection and may not prevent you from spreading hepatitis C infection to others.
- Pegasys 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.
- Diabetes patients - Check your blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Tell your doctor or dentist that you take Pegasys 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 Pegasys. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Pegasys 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).
- Pegasys 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.
- Pegasys 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 Pegasys. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Pegasys while you are pregnant. Use of Pegasys with ribavirin during pregnancy has resulted in birth defects and fetal death. It is not known if Pegasys is found in breast milk. Do not breast-feed while taking Pegasys.
Possible side effects of Pegasys:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); 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; coughing up yellow or pink mucus; dark urine, change in the amount of urine produced, or burning or painful urination; decreased coordination; difficulty hearing or hearing loss; eye pain or redness; fainting; fast, slow, or irregular heartbeat; new or worsening mental or mood problems (eg, anxiety, aggressive or unusual behavior, depression, hallucinations, irritability, suicidal thoughts or actions); numbness of an arm or leg; one-sided weakness; pale stools; persistent loss of appetite; persistent or severe diarrhea, nausea, stomach or back 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, headache, or vomiting; sudden shortness of breath; unusual bruising or bleeding; vision loss or other vision changes; vomit that looks like coffee grounds; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Pegasys:
Store Pegasys 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 Pegasys out of the reach of children and away from pets.
- If you have any questions about Pegasys, please talk with your doctor, pharmacist, or other health care provider.
- Pegasys 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Pegasys or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pegasys. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pegasys. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Pegasys.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.