Peginterferon Alfa-2b (E. coli) Solution for injection

What is this medicine?

PEGINTERFERON ALFA-2b (peg in ter FEER on AL fa 2 b) is a man-made drug that acts like a protein made by the body. It is used to treat chronic hepatitis 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:

• alcoholism
• auto-immune hepatitis
• blood or bleeding disorders
• colitis like ulcerative colitis or Crohn's disease
• depression or other mental disorders
• diabetes
• drug abuse or addiction
• heart disease
• kidney disease
• lupus
• psoriasis
• rheumatoid arthritis
• thyroid problems
• an unusual or allergic reaction to peginterferon, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

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.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 years for selected conditions, precautions do apply.

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, take it as soon as you can. If several days have passed since you missed your dose ask your doctor what to do. Do not take more than one dose in a week unless your doctor tells you to. Do not take double or extra doses.

What may interact with this medicine?

• dextromethorphan
• flecainide
• methadone
• phenytoin
• theophylline
• tolbutamide
• warfarin

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:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• bloody diarrhea
• breathing problems
• change in blood sugar
• changes in vision
• chest pain
• fast, irregular heartbeat
• fever
• increased anger, depression, irritability, or thoughts of suicide
• pain in lower back or stomach
• pain, tingling, numbness in the hands or feet
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches, pains
• dry, itchy skin
• hair loss
• headache
• loss of appetite
• nausea or stomach upset
• pain or swelling at site where injected
• trouble sleeping
• unusually weak or tired

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.

Vials: Store unmixed vials at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Throw away any unused medicine after the expiration date. After mixing, store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F) and use in 24 hours or less. Protect from light.

PEG-Intron Redipen: should be stored refrigerated between 2 and 8 degrees C (between 36 and 46 degrees F). Do not freeze. This is a single use pen. It does not contain preservatives. After mixing, use immediately. If needed, it may be stored in the refrigerator (2and8 degrees C or 36and46 degrees F) for up to 24 hours.

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.