PegIntron Redipen

Peginterferon alfa-2b is used alone or in combination with ribavirin to treat chronic hepatitis C, a viral infection of the liver. 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.

If you miss a dose, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using peginterferon alfa-2b 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 thigh, the outer surface of your upper arm, or stomach 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. The dose should be given at about the same time on the same day each week. The dosage is based on your body weight, medical condition and response to therapy. 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. 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.

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, methadone, stavudine, telbivudine, theophylline, zidovudine.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood tests, thyroid tests, virus levels, kidney function tests, triglyceride levels) should be performed periodically to monitor your progress. Depending on your medical history, other tests (e.g., EKG) may be needed. Consult your doctor for more details. You may need an eye exam before using this medication. If you have an eye disease or have a condition that places you at greater risk for eye disease (e.g., diabetes), you should then have periodic eye exams while using this drug. Do not change brands of interferon without checking with your doctor or pharmacist. Other interferons may not have the same effects on your disease.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Before using peginterferon alfa-2b, 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 using this medication tell your doctor or pharmacist your medical history, especially of: psychiatric conditions (e.g., depression), history of drug/alcohol abuse, sleep problems, 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), cancer, inflammation of the bowels (e.g., colitis), pancreatitis, diabetes, other infections (HIV, hepatitis B), high blood triglyceride levels, history of organ transplant. 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. 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 using this medication 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.

Consult the product instructions and your pharmacist for storage details. 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.

Flu-like symptoms (e.g., fever, chills, muscle aches, fatigue, headache, joint pain, nausea, stomach pain) may occur. If instructed to do so, taking pain/fever-reducing medications (e.g., acetaminophen, ibuprofen) or injecting this medication at bedtime may help reduce some of these symptoms. Dry mouth, increased sweating, loss of appetite, weight loss, trouble sleeping, diarrhea, dry skin, redness/swelling at the injection site, throat/sinus infections, or menstrual period problems may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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, increased thirst/urination, unusually slow/fast/pounding heartbeat, severe stomach pain with nausea/vomiting, 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, seizures, one-sided weakness. This drug may infrequently cause severe mental/mood changes (e.g., suicidal thoughts or severe depression). If you notice these symptoms, stop your treatment with peginterferon and get medical help right away. 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.

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. Ribavirin is a potential cancer-causing agent.