In the U.S.—

• Biological response modifier

Peginterferon alfa-2b (peg-in-ter-FEER-on alfa-2b ) is a synthetic (man-made) version of substances normally produced in the body to fight infection. Peginterferon alfa-2b is used to treat chronic hepatitis C. It is used for patients who have never been treated by alpha interferons and who do not have symptoms of worsening liver disease.

This medicine is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For peginterferon alfa-2b, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to peginterferon alfa-2b. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Peginterferon alfa-2b has not been studied in pregnant women. However, studies in animals have shown that peginterferon alfa-2b causes death of the fetus. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether peginterferon alfa-2b passes into the breast milk. However, peginterferon alfa-2b is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of peginterferon alfa-2b in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Autoimmune hepatitis—May cause severe disease affecting other parts of the body

• Decompensated liver disease—May cause liver disease to become worse

• Diabetes mellitus (sugar diabetes) or
• Heart or blood vessel disease or
• Hyperglycemia (high blood sugar) or
• Kidney disease or
• Lung disease
• Psoriasis or
• Psychiatric problems or
• Rheumatoid arthritis or
• Systemic lupus erythematosus or
• Thyroid disease—May be worsened by peginterferon alfa-2b

• Human immunodeficiency virus (HIV) infection or
• Liver or other organ transplant—It is not known if peginterferon alfa-2b will work in patients with these conditions

If you are injecting this medicine yourself, use it exactly as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much will increase the risk of side effects, while using too little may not improve your condition.

Each package of peginterferon alfa-2b contains a patient instruction sheet. Read this sheet carefully and make sure you understand:

• How to prepare the injection.
• Proper use of disposable syringes.
• How to give the injection.
• How long the injection is stable.

If you have any questions about any of this, check with your health care professional.

Dosing—

The dose of peginterferon alfa-2b will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of peginterferon alfa-2b. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For treating chronic hepatitis C:
    • Adults—Dose is based on body weight. It is usually between 40 and 150 micrograms (mcg) injected under the skin once a week for one year. The medicine should be taken on the same day each week.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible if you remember it the same or the next day. If you remember after that, check with your doctor for instructions. Do not double doses or take more than one dose within a week.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places.
• Store in the refrigerator after you have mixed the powder with the sterile water. You can keep it up to 24 hours. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

You may have feelings of anxiety or depression while taking peginterferon alfa-2b. Call your doctor right away if you have these feelings or if you are thinking about hurting yourself or someone else.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Abdominal pain;  anxiety;  black, tarry stools;  blood in urine or stools;  bloody diarrhea;  chills;  cough or hoarseness;  depression;  fever;  infection ;  irritability;  lower back or side pain;  mood swings;  nausea;  painful or difficult urination;  pinpoint red spots on skin;  trouble in sleeping;  unusual bleeding or bruising;  vomiting 
  
  

• Less common
  • Changes in menstrual cycle;  constipation ;  drowsiness;  dry hair and skin;  sensitivity to cold;  unusual tiredness or weakness;  weight gain 
  
  

• Rare
  • Aching, pain, and/or stiffness in joints;  aggressive behavior;  attempt to kill yourself;  backache;  chest pain (severe);  cool, pale skin;  decrease in vision ;  diarrhea;  difficulty speaking ;  dizziness;  drug addiction or overdose;  eye pain;  fast or irregular heartbeat;  feeling of constant movement of self or surroundings;  headache;  hives or skin rash;  itching of skin ;  loss of appetite;  muscle weakness;  nervousness;  numbness or loss of feeling in one or both limbs on the same side of the body ;  palpitations;  paralysis ;  possible decrease in amount of urine;  restlessness;  sensation of spinning ;  sensitivity to heat;  sensitivity to sunlight;  shortness of breath;  sweating (excessive);  thoughts of killing someone;  thoughts of killing yourself;  thick, scaly skin;  trouble in sleeping ;  warm, smooth, moist skin;  weight loss 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Aching, fullness, or tension in sinuses;  bruising, irritation, or itching at place of injection;  flushing of skin;  hair loss;  indigestion;  pain in bones or muscles;  runny nose;  sneezing;  sore throat 
  
  

• Less common
  • Muscle rigidity or stiffness;  pain at place of injection 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.