Peginterferon alfa-2b Generic Name:
Peginterferon alfa-2b (peg-IN-ter-FEER-on AL-fa)Brand Name:
Peginterferon alfa-2b may cause or worsen fatal or life-threatening mental, immune system, heart, blood vessel, and infectious disorders. Contact your doctor immediately if worsening of signs or symptoms occur.
Peginterferon alfa-2b may be used in combination with another medicine called ribavirin. Ribavirin may cause birth defects or fetal death. Women who are using this combination or whose male partners are using this combination should avoid becoming pregnant. Ribavirin may also cause severe anemia, which may worsen heart disease. Ribavirin may also cause cancer.
Peginterferon alfa-2b is used for:
The treatment of chronic hepatitis C virus infection. Peginterferon alfa-2b is used alone or with other medicines.
Peginterferon alfa-2b is an interferon. It works by increasing the response of the body's immune system against the virus.
Do NOT use Peginterferon alfa-2b if:
- you are allergic to any ingredient in Peginterferon alfa-2b or you have had an allergic reaction to similar medicines
- you have hepatitis caused by your immune system attacking your liver (autoimmune hepatitis) or severely decreased liver function
Contact your doctor or health care provider right away if any of these apply to you.
Before using Peginterferon alfa-2b :
Some medical conditions may interact with Peginterferon alfa-2b . 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, suicidal thoughts or actions, sleeping problems, or a history of addiction to alcohol or other substances
- if you have kidney problems or liver problems (eg, cirrhosis, chronic hepatitis B)
- if you have cancer, a weakened immune system (eg, HIV), an autoimmune disorder (eg, lupus, rheumatoid arthritis, psoriasis), or you have a history of an organ transplant
- if you have a history of heart attack, other heart or blood vessel problems, or high blood pressure
- if you have diabetes, blood problems (eg, sickle cell anemia, thalassemia), bleeding problems, thyroid problems, lung problems, inflammation of the pancreas, high blood triglyceride levels, bowel inflammation (colitis), or eye problems (eg, caused by diabetes or high blood pressure)
Some MEDICINES MAY INTERACT with Peginterferon alfa-2b . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Fluorouracil or methadone because the risk of their side effects may be increased
- Flecainide, phenytoin, or warfarin because their effectiveness may be decreased by Peginterferon alfa-2b
This may not be a complete list of all interactions that may occur. Ask your health care provider if Peginterferon alfa-2b 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-2b :
Use Peginterferon alfa-2b as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Peginterferon alfa-2b comes with an additional patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Peginterferon alfa-2b refilled.
- A health care provider will teach you how to use Peginterferon alfa-2b . 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 Peginterferon alfa-2b 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 Peginterferon alfa-2b if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Do not inject Peginterferon alfa-2b into an area that is irritated, bruised, red, infected, 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.
- Drinking extra fluids while you are taking Peginterferon alfa-2b is recommended. Check with your doctor for instructions.
- Peginterferon alfa-2b 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 Peginterferon alfa-2b 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 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 Peginterferon alfa-2b 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 per week without checking with your doctor.
Ask your health care provider any questions you may have about how to use Peginterferon alfa-2b .
Important safety information:
- Peginterferon alfa-2b may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Peginterferon alfa-2b 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. If you use more than your prescribed dose, contact your doctor right away.
- It is not known if Peginterferon alfa-2b will prevent the spread of hepatitis C virus to others. It is also not known if it will cure hepatitis C or prevent liver disease (eg, cirrhosis, liver failure, liver cancer) that may be associated with hepatitis C virus.
- Peginterferon alfa-2b 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-2b 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-2b 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.
- Peginterferon alfa-2b may cause mental or mood problems. The risk may be greater if you have a history of mental or mood problems, suicidal thoughts or actions, or addiction to alcohol or another substance. Contact your doctor at once if you experience 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.
- Men who use Peginterferon alfa-2b should not have sex with a pregnant woman. If you are a male patient with a female partner who may become pregnant, you must use effective birth control during treatment with Peginterferon alfa-2b and for 6 months after you stop treatment.
- Tell your doctor or dentist that you take Peginterferon alfa-2b before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, such as blood tests, virus levels, and eye exams, may be performed while you use Peginterferon alfa-2b . 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-2b with caution in the ELDERLY; they may be more sensitive to its effects and are at an increased risk of serious side effects.
- Caution is advised when using Peginterferon alfa-2b in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, vomiting, and decreased ability to fight infection.
- Peginterferon alfa-2b may affect height and weight gain in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Peginterferon alfa-2b .
- Peginterferon alfa-2b should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not use Peginterferon alfa-2b if you are pregnant. Do not become pregnant for 6 months after you stop treatment with Peginterferon alfa-2b . Use an effective form of birth control during treatment with Peginterferon alfa-2b and for 6 months after you stop treatment. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Peginterferon alfa-2b while you are pregnant. It is not known if Peginterferon alfa-2b is found in breast milk. Do not breast-feed while taking Peginterferon alfa-2b .
Possible side effects of Peginterferon alfa-2b :
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; dry mouth or skin; flushing; hair thinning or loss; headache; increased sweating; joint pain; loss of appetite; muscle aches; nausea; stomach pain or upset; stuffy nose; temporary redness, swelling, or itching at the injection site; tiredness; trouble sleeping; vomiting; weakness; weight loss.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); blood in the urine; bloody stools or diarrhea; butterfly-shaped rash on the face; chest pain; confusion; decreased hearing or hearing loss; decreased urination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; memory loss; mental or mood problems (eg, aggression, depression, exaggerated sense of well-being, irritability); numbness or weakness on one side of the body; red, swollen, blistered, or peeling skin; severe or persistent dizziness, tiredness, or weakness; severe or persistent joint or muscle pain; severe or persistent nausea or vomiting; severe or persistent stomach or lower back pain; shortness of breath; slurred speech; suicidal thoughts or actions; swelling in the hands or feet; symptoms of high blood sugar (eg, increased thirst, appetite, or urination; rapid breathing; unusual drowsiness); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unexplained weight changes); thoughts of hurting yourself or other people; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.
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-2b :
Redipen: Store Peginterferon alfa-2b 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).
Vial: Store the powder at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Avoid exposure to heat. After mixing, the solution should be used immediately. Mixed solution may be stored in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) for up to 24 hours.
The solution does not contain a preservative. Do not freeze. Keep Peginterferon alfa-2b out of the reach of children and away from pets.
- If you have any questions about Peginterferon alfa-2b , please talk with your doctor, pharmacist, or other health care provider.
- Peginterferon alfa-2b 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-2b . 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-2b Detailed Consumer Information (PDR)
- Peginterferon Alfa-2b Professional Patient Advice (Wolters Kluwer)
- peginterferon alfa-2b Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
- peginterferon alfa-2b Concise Consumer Information (Cerner Multum)
- Pegintron Prescribing Information (FDA)