May cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be closely monitored with periodic clinical and laboratory evaluations. Discontinue peginterferon alfa in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after the drug is discontinued.
Concomitant use of ribavirin: ribavirin may cause birth defects and/or death of the fetus. Extreme care must be used to avoid pregnancy in females and in female partners of male patients. Ribavirin causes hemolytic anemia; this may result in worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
REMS:
FDA approved a REMS for peginterferon alfa to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of peginterferon alfa and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
PEGINTERFERON ALFA-2a (peg in ter FEER on AL fa 2 a) is a man-made drug that acts like a protein made by the body. It is used to treat chronic hepatitis B and C infections.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection under the skin. Do NOT shake this medicine. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose and you remember within 2 days of when you missed your dose, take it as soon as you can. If it is late in the day, wait until the next day to take your dose. If more than 2 days have passed since you missed your dose ask your doctor what to do. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress. You will need regular blood checks.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Protect from light. Do not leave this medicine out of the refrigerator for more than 24 hours. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
