Generic Name: peginterferon alfa-2b (peg-IN-ter-FEER-on AL-fa)
Brand Name: PEG-Intron Redipen
PEG-Intron may cause or worsen certain fatal or life-threatening medical conditions. These may include mental or mood problems, autoimmune diseases, blood vessel problems, and infection. In many cases, these problems go away after stopping PEG-Intron, but not always. Contact your doctor right away if new or worsening symptoms or side effects occur.
PEG-Intron may be used along with another medicine called ribavirin. Ribavirin may cause birth defects or fetal death. Women who are using this combination should avoid becoming pregnant. Women whose male partners are using this combination should also avoid pregnancy. Ribavirin may also cause a certain type of anemia (hemolytic anemia), which may worsen heart disease. Ribavirin may also cause cancer. Discuss any questions or concerns with your doctor.
PEG-Intron is used for:
Treating chronic hepatitis C virus infection in certain patients. PEG-Intron is used alone or with other medicines.
PEG-Intron 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 PEG-Intron if:
- you are allergic to any ingredient in PEG-Intron or to another interferon alfa
- you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or certain other liver problems
- 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 PEG-Intron:
Some medical conditions may interact with PEG-Intron. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- 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 mental or mood problems (eg, depression), suicidal thoughts or actions, sleeping problems, or alcohol or other substance abuse or dependence
- if you have a history of other liver problems (eg, cirrhosis, hepatitis B)
- if you have a history of cancer, a weakened immune system, HIV infection, bone marrow problems (eg, low white blood cell levels, low platelet levels), an autoimmune disorder (eg, lupus, rheumatoid arthritis, psoriasis), or an organ transplant
- if you have a history of heart attack or other heart problems (eg, fast or irregular heartbeat), blood vessel problems, or high or low blood pressure
- if you are on dialysis or have a history of kidney problems, diabetes or high blood sugar, blood problems (eg, sickle cell anemia, thalassemia), stroke, blood clots, bleeding problems, thyroid problems, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], pneumonia), pancreatitis, high blood triglyceride levels, a certain type of bowel inflammation (colitis), or eye or vision problems (eg, those caused by diabetes or high blood pressure)
- if you have poor dental hygiene or other dental problems
Some MEDICINES MAY INTERACT with PEG-Intron. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Telbivudine because the risk of burning, numbness, or tingling in the arms or legs may be increased
- Methadone or desipramine because the risk of their side effects may be increased
- Flecainide, phenytoin, or warfarin because their effectiveness may be decreased by PEG-Intron
This may not be a complete list of all interactions that may occur. Ask your health care provider if PEG-Intron 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 PEG-Intron:
Use PEG-Intron as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- PEG-Intron comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get PEG-Intron refilled.
- A health care provider will teach you how to use PEG-Intron. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use your dose of PEG-Intron 1 time per week unless your doctor tells you otherwise. Take it on the same day of each week, at about the same time of day.
- Do not use PEG-Intron if it contains particles, is cloudy or discolored, or if the container is cracked or damaged.
- Do not inject PEG-Intron into an area that is irritated, bruised, red, infected, or scarred, or has stretch marks.
- Two hours after the injection, check the injection site for redness, swelling, or tenderness. If you have a skin reaction and it does not clear up in a few days, contact your health care provider.
- Do not reuse the Redipen. Throw away any medicine that may be left in the Redipen after your dose.
- Drinking extra fluids while you are taking PEG-Intron is recommended. Check with your doctor for instructions.
- PEG-Intron may cause flu-like side effects (eg, fever, headache, muscle aches, tiredness). Some of these effects (fever, headache) usually improve after the first few weeks of treatment. These effects may be decreased if you use PEG-Intron at bedtime or take a nonprescription pain and fever reducer (eg, acetaminophen, ibuprofen). Check with your doctor if these effects persist or are severe.
- Keep this product, as well as syringes and needles, out of the reach of children and away from 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.
- If you miss a dose of PEG-Intron and you remember on the same day or the next day, use the missed dose and then go back to your regular dosing schedule. If several days have passed before you remember, check with your doctor about what to do. Do not use 2 doses at once. Do not use more than 1 dose in 1 week without checking with your doctor.
Ask your health care provider any questions you may have about how to use PEG-Intron.
Important safety information:
- PEG-Intron may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use PEG-Intron with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or stop using PEG-Intron without checking with your doctor. If you use more than your prescribed dose, contact your doctor right away.
- It is not known if the use of PEG-Intron for longer than 1 year is safe and will work. Discuss any questions or concerns with your doctor.
- It is not known if PEG-Intron will prevent the spread of hepatitis C virus to others. It is also not known if it will prevent liver disease (eg, cirrhosis, liver failure, liver cancer) that may be associated with hepatitis C virus.
- PEG-Intron 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.
- PEG-Intron 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.
- PEG-Intron may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking it. Brush and floss your teeth and visit the dentist regularly.
- If vomiting occurs while you are taking PEG-Intron, be sure to rinse your mouth and clean your teeth afterwards.
- PEG-Intron may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- PEG-Intron may cause new or worsening mental or mood problems. The risk may be greater if you have a history of mental or mood problems, or suicidal thoughts or actions. Contact your doctor at once if you develop new or worsened depression; aggressive, restless, or irritable behavior; thoughts of hurting another person; or any unusual change in mood or behavior. Contact your doctor at once if you experience suicidal thoughts or actions. Your doctor will monitor you during treatment and for 6 months after your last dose.
- Severe and sometimes fatal pancreatitis has happened with PEG-Intron. Call your doctor right away if you have severe or persistent stomach or back pain (with or without nausea or vomiting).
- Severe and sometimes fatal lung problems have happened with PEG-Intron. Call your doctor right away if you have symptoms of lung problems (eg, trouble breathing, shortness of breath, cough that is new or worse).
- A severe and sometimes deadly bowel problem (colitis) has happened within 12 weeks of treatment with alpha interferons like PEG-Intron. Call your doctor right away if you have severe stomach pain, bloody stools or diarrhea, vomiting blood, or vomit that looks like coffee grounds.
- Severe and sometimes fatal liver problems have happened with PEG-Intron. Call your doctor right away if you have symptoms of new or worsening liver problems (eg, bloating of the stomach, dark urine, pale stools, persistent loss of appetite, unusual diarrhea or stomach pain, yellowing of the skin or eyes).
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- If you are able to become pregnant, you should use effective birth control while taking PEG-Intron. Check with your doctor if you have questions about using birth control.
- Tell your doctor if you take a medicine that contains caffeine or you eat or drink products that contain caffeine (eg, coffee, tea, cocoa, cola, chocolate).
- Tell your doctor or dentist that you take PEG-Intron before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including virus levels; eye exams; blood counts; heart, liver, kidney, thyroid, and lung function tests; and blood glucose levels, may be performed while you use PEG-Intron. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use PEG-Intron with caution in the ELDERLY; they may be more sensitive to its effects, especially heart, lung, stomach or bowel problems; mental or mood problems; and flu-like symptoms.
- PEG-Intron may affect height and weight gain in CHILDREN and teenagers in some cases. They may need regular growth checks while they use PEG-Intron.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using PEG-Intron while you are pregnant. Do not use PEG-Intron along with ribavirin if you are pregnant or are planning to become pregnant within 6 months of using it. Use of PEG-Intron with ribavirin during pregnancy has resulted in birth defects and fetal death. It is not known if PEG-Intron is found in breast milk. Do not breast-feed while taking PEG-Intron.
Possible side effects of PEG-Intron:
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; dry mouth or skin; hair thinning or loss; headache; joint pain; loss of appetite; mild stomach pain; muscle aches; nausea; temporary pain, redness, swelling, or itching at the injection site; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning or painful urination; butterfly-shaped rash on the face; change in the amount of urine produced; chest, jaw, or arm pain; confusion; coughing up yellow or pink mucus; decreased hearing or hearing loss; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; memory loss; new or worsening mental or mood problems (eg, aggression, anxiety, depression, exaggerated sense of well-being, irritability); numbness or weakness on one side of the body; seizures; severe or persistent dizziness, light-headedness, or headache; severe or persistent joint or muscle pain; severe or persistent nausea or vomiting; slurred speech; suicidal thoughts or actions; symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unexplained skin changes or weight changes); thoughts of hurting yourself or other people; unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness; vision loss or other vision changes.
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 PEG-Intron:
Store PEG-Intron in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). The prepared solution should be used immediately but may be stored for up to 24 hours in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. The solution does not contain a preservative. Store away from heat, moisture, and light. Keep PEG-Intron out of the reach of children and away from pets.
- If you have any questions about PEG-Intron, please talk with your doctor, pharmacist, or other health care provider.
- PEG-Intron 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 PEG-Intron 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 PEG-Intron. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to PEG-Intron. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health careprovider for complete information about the risks and benefits of using PEG-Intron.
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.
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