GENERIC NAME: PEGINTERFERON ALFA-2A - INJECTION (peg-IN-ter-FEER-on AL-fa too-ay)
BRAND NAME(S): Pegasys
WARNING: This medication may cause or worsen some serious medical conditions, including psychiatric conditions (e.g., depression); immune disorders (autoimmune conditions such as rheumatoid arthritis or lupus); circulation problems (e.g., cardiovascular disease); or infections (bone marrow suppression). Seek immediate medical attention if you develop any serious symptoms or side effects (see Side Effects section). These conditions occur infrequently, but some may be fatal.
This medicine is frequently combined with ribavirin. Ribavirin may cause harm to an unborn baby or death. Women must avoid pregnancy while they or their male partners are using ribavirin. Ribavirin may cause a blood disorder (hemolytic anemia), which can worsen heart disease. If you are using peginterferon alfa-2a with ribavirin to treat chronic hepatitis C, also carefully read the drug information for ribavirin.
USES: Peginterferon alfa-2a is used alone or in combination with ribavirin to treat chronic hepatitis C, a viral infection of the liver. It may also be used in combination with ribavirin and a protease inhibitor to treat chronic hepatitis C. Peginterferon alfa-2a is also used to treat chronic hepatitis B infection.This medication reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if peginterferon can cure hepatitis C virus infections (permanently eliminate the virus from your body). It is also not known if this drug can prevent you from passing the virus to others. Practice "safe sex" (including the use of latex condoms) to lower the risk of passing the virus to others.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using peginterferon alfa-2a and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Inject this medication under the skin (subcutaneously) on your stomach or thigh, once weekly or as directed by your doctor. Do not inject near the belly button or at the waistline. Use a different place each time you give yourself an injection. Do not shake this medication. Doing so may decrease the effectiveness of this medication. The dose should be given at about the same time on the same day each week. The dosage is based on your medical condition and response to therapy.Drink plenty of fluids while you are taking this medication unless your doctor directs you otherwise. Additional administration guidelines may be available in the Medication Guide.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
SIDE EFFECTS: Flu-like symptoms (e.g., fever, chills, muscle aches, fatigue, headache, joint pain, nausea, stomach pain, cough) may occur. If instructed to do so, you may take pain/fever-reducing medications (e.g., acetaminophen, ibuprofen) to help with these symptoms. Dry mouth, loss of appetite, weight loss, trouble sleeping, diarrhea, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Tooth and gum problems may sometimes occur during treatment. Having a dry mouth can worsen this side effect. Prevent dry mouth by drinking plenty of water or using a saliva substitute. Brush your teeth well at least twice a day and have regular dental exams. If you experience vomiting during treatment, rinse your mouth afterwards to lessen the chance of tooth and gum problems.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: persistent sore throat or fever, easy or unusual bleeding/bruising, unusually severe fatigue, unusually slow/fast/pounding heartbeat, severe stomach pain with nausea/vomiting, black/tarry stools, vomit that looks like coffee grounds, yellowing eyes or skin, dark urine, increased thirst/urination, bloody diarrhea, numbness/tingling of arms/legs.Get medical help right away if any of these rare but very serious side effects occur: chest pain, vision changes (such as blurred vision, partial loss of vision), seizures, one-sided weakness.This drug may cause you to develop serious mental/mood changes that may get worse during treatment or after your last dose. Tell your doctor right away if you have symptoms such as confusion, depression, suicidal thoughts, unusual irritability, or aggressive behavior. If this occurs, psychiatric therapy and monitoring is recommended during and after treatment with this medication.A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using peginterferon alfa-2a, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other severe liver disease (e.g., autoimmune hepatitis, hepatic decompensation).Before taking this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (e.g., depression), low blood counts (e.g., red cells, white cells, or platelets), heart disease, thyroid problems, autoimmune disease (e.g., rheumatoid arthritis, lupus, psoriasis), eye problems, kidney disease, lung disease (e.g., COPD, asthma, pneumonia), history of cancer, intestinal disease ( e.g., colitis), pancreatitis, history of drug/alcohol abuse, diabetes, other infections (e.g., HIV, hepatitis B, chickenpox), high blood triglyceride levels, history of organ transplant, liver problems (other than hepatitis C).Do not have immunizations/vaccinations without the consent of your doctor.Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.This drug may make you drowsy or dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.This medicine may cause stomach bleeding. Daily use of alcohol and this medicine may increase your risk for stomach bleeding.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the side effects of this drug, especially mental/mood changes (such as severe depression, thoughts/attempts of suicide). Peginterferon and ribavirin may also slow down a child's rate of growth. Normal weight gain and rate of growth usually return after treatment is completed but the final adult height may be lower than expected. Monitor your child's height and weight periodically during treatment.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.This medication is not recommended for use during pregnancy because of possible serious harm to the unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use birth control measures while being treated with this medication and for the 6 months after treatment has stopped. If you become pregnant or think you may be pregnant, inform your doctor immediately.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: hydroxyurea, lamivudine, stavudine, telbivudine, theophylline, zidovudine.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood counts, thyroid tests, virus levels, kidney/liver function, triglyceride levels, eye exams) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Depending on your medical history, other tests (such as EKG) may be needed. Consult your doctor for more details.Do not change brands of interferon without checking with your doctor or pharmacist. Other interferons may not have the same effects on your disease.
MISSED DOSE: If you miss a dose and you remember within 2 days of when you should have taken the medication, give the injection as soon as remembered. Take your next dose on the day you usually take it. If more than 2 days have passed since your missed dose, contact your doctor or pharmacist to establish a new dosing schedule.
STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C). This medication should not be left outside the refrigerator for more than 24 hours. Protect from light. Do not freeze. Each vial or prefilled syringe can be used only once; discard any unused portion. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.
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