peginterferon alfa-2b
What is the most important information I should know about peginterferon alfa-2b?
You should not use peginterferon alfa-2a with ribavirin if you are pregnant, or if you are a man whose sex partner is pregnant. Use effective birth control to prevent pregnancy while taking ribavirin and for at least 6 months after your last dose.
Peginterferon alfa-2b may cause serious or fatal side effects.
Tell your doctor about any new or worsening mood symptoms, such as feeling irritable, hostile, aggressive, depressed, or having thoughts about suicide or hurting yourself.
Call your doctor right away if you have symptoms such as chest pain, fast heartbeats, trouble breathing, numbness or weakness, vision or speech problems, fever, chills, a cough with mucus, burning when you urinate, or bloody diarrhea.
What is peginterferon alfa-2b?
Peginterferon alfa-2b is used in combination with ribavirin or other medications to treat chronic hepatitis C in adults and children who are at least 3 years old.
The Sylatron brand of this medicine is used only in adults, to treat melanoma (skin cancer) after surgery.
Peginterferon alfa-2b may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using peginterferon alfa-2b?
You should not use peginterferon alfa-2b if:
- you are allergic to any type of interferon alfa; or
- you have autoimmune hepatitis, or severe liver damage.
When taking peginterferon alfa-2b with other medicine: To make sure all medicines are safe for you, tell your doctor about all your medical conditions, and if you are pregnant or breastfeeding.
You should not use peginterferon alfa-2b with ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant.
Peginterferon alfa-2b can worsen a medical condition you already have. Tell your doctor if you have ever had:
- both hepatitis B and hepatitis C, or HIV/AIDS;
- liver problems other than hepatitis B or C;
- heart problems, high blood pressure, heart attack, stroke, or blood clot;
- an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
- kidney disease (or if you are on dialysis);
- depression, mental illness, suicidal thoughts or actions;
- bleeding problems, low blood cell counts;
- breathing problems (such as COPD);
- ulcerative colitis;
- high triglycerides;
- diabetes, or a thyroid disorder;
- an organ transplant; or
- a drug or alcohol addiction.
You may need to have a negative pregnancy test before starting this treatment.
Peginterferon alfa-2b is sometimes used in combination with ribavirin. Both men and women using ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.
You should not take ribavirin if you are pregnant, or if you are a man and your sex partner is pregnant. Use effective birth control to prevent pregnancy. Keep using birth control for at least 6 months after your last dose of ribavirin.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ribavirin.
This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because peginterferon alfa-2b can harm an unborn baby.
It may not be safe to breastfeed while using peginterferon alfa-2b. Ask your doctor about any risk.
How should I use peginterferon alfa-2b?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Peginterferon alfa-2b is often used with other medicines. Use all medications exactly as directed.
Peginterferon alfa-2b is injected under the skin, usually once per week. A healthcare provider may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.
Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Your doctor may recommend you take a fever-reducer medication at bedtime to help prevent flu-like symptoms. Use this medicine for as long as your doctor has prescribed.
Pay special attention to your dental hygiene and have regular dental exams while using peginterferon alfa-2b. Rinse your mouth well if you vomit at any time while using peginterferon alfa-2b.
You may need frequent medical tests.
Store peginterferon alfa-2b vials (bottles) in their original package at room temperature, away from moisture and heat. Do not freeze. Do not reuse a vial or injection pen.
Store the injection pen in a refrigerator. Do not freeze. Mixed medicine may also be stored in the refrigerator but you must use it within 24 hours after mixing. Do not freeze or save any unused mixture.
Each injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include headache, extreme tiredness, muscle pain, fever, sore throat, trouble breathing, bruising or bleeding.
What should I avoid while using peginterferon alfa-2b?
Avoid coffee, tea, energy drinks, or other products that contain caffeine.
Using this medicine will not prevent you from passing hepatitis to other people. Follow your doctor's instructions about how to avoid passing the disease to another person.
What are the possible side effects of peginterferon alfa-2b?
Get emergency medical help if you have signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; chest pain, anxiety, difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have unusual changes in mood or behavior, such as: depression, irritability, feeling hostile or aggressive, hallucinations, thoughts about hurting yourself, or falling back into a previous pattern of drug addiction. These symptoms may occur during treatment and up to 6 months after your last dose.
Peginterferon alfa-2b may cause serious or fatal side effects. Call your doctor at once if you have:
- severe stomach pain with bloody diarrhea;
- new or worsening cough, cough with mucus, trouble breathing;
- numbness, tingling, or burning in your arms or legs;
- sudden numbness or weakness, slurred speech, problems with balance;
- vision changes;
- low blood cell counts --fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
- high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
- pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting;
- thyroid problems --weight changes, skin changes, thinking problems, feeling hot or cold all the time; or
- worsening liver symptoms --swelling around your midsection, nausea, diarrhea, loss of appetite, confusion, drowsiness, yellowing of the skin or eyes, loss of consciousness.
Combination treatment with peginterferon alfa-2b and ribavirin can affect growth in children. Tell your doctor if you think your child is not growing at a normal rate while using this combination.
Common side effects may include:
- fever, chills, feeling weak or tired;
- low white blood cells counts;
- mood changes, feeling anxious or irritable;
- headache, muscle pain;
- nausea, vomiting, loss of appetite;
- abnormal liver function tests; or
- redness, swelling, or other irritation where the medicine was injected.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect peginterferon alfa-2b?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Other drugs may affect peginterferon alfa-2b, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your doctor or pharmacist can provide more information about peginterferon alfa-2b.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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