Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. PEG-Intron
  2. Peg Intron RP
  3. Sylatron

Descriptions


Peginterferon alfa-2b injection is a synthetic (man-made) version of substances normally produced in the body to fight infection. Peginterferon alfa-2b injection is used alone or together with ribavirin and another drug called a hepatitic C virus (HCV) NS3/4A protease inhibitor (such as telaprevir or boceprevir) to treat chronic hepatitis C infection. It is used for patients who have never been treated by alpha interferons. The combination treatment of peginterferon alfa-2b and ribavirin is used to treat adults and children 3 years of age and older who show symptoms of liver damage.

Peginterferon alfa-2b injection is also used to prevent malignant melanoma (a type of skin cancer) from coming back after it has been removed by surgery. This medicine should be started within 84 days of surgery to remove lymph nodes containing cancer.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Powder for Solution
  • Kit

Before Using

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Pegintron® in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Sylatron™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of peginterferon alfa-2b injection in the elderly. However, elderly patients are likely to be more sensitive to the effects of this medicine, and are more likely to have age-related kidney problems, which may require caution in patients receiving this medicine.

Pregnancy

Information about this peginterferon-alfa-2b-subcutaneous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic reactions (e.g., anaphylaxis, bronchoconstriction, Stevens-Johnson syndrome) or
  • Autoimmune hepatitis (liver inflammation) or
  • Decompensated liver disease—Should not be used in patients with these conditions.
  • Angina (severe chest pain) or
  • Heart attack, history of or
  • Heart or blood vessel disease or
  • Heart rhythm problems (e.g., arrhythmia , tachycardia), history of or
  • Hypotension (low blood pressure)—Use with caution. Patients with these conditions should be closely monitored while using this medicine.
  • Bone marrow problems (e.g., aplastic anemia) or
  • Brain disease (e.g., encephalopathy) or
  • Breathing problems or other lung diseases (e.g., chronic obstructive pulmonary disease or COPD, pneumonia, pulmonary infiltrates, sarcoidosis), or history of or
  • Depression or mental illness, history of or
  • Diabetes mellitus (sugar diabetes) or
  • Diabetic retinopathy (eye problem caused by diabetes) or
  • Eye or vision problems (e.g., retinopathy, optic neuritis) or
  • Hyperglycemia (high blood sugar level) or
  • Hypertensive retinopathy (eye problem caused by hypertension or high blood pressure) or
  • Hypertriglyceridemia (high triglyceride levels or fats in the blood) or
  • Kidney disease or
  • Liver disease (including cirrhosis), severe or
  • Psoriasis or
  • Psychiatric problems, history of or
  • Rheumatoid arthritis or
  • Systemic lupus erythematosus or
  • Thyroid disease or
  • Type 1 diabetes—Use with caution. May make these conditions worse.
  • Colitis (inflammation of the bowel) or
  • Pancreatitis (inflammation of the pancreas)—Peginterferon alfa-2b should be stopped in patients with these conditions.
  • Heart disease (severe and unstable), or history of or
  • Kidney disease, severe or
  • Sickle cell anemia (red blood cell disorder) or
  • Thalassemia major (genetic blood disorder)—Peginterferon alfa-2b together with ribavirin should not be used in patients with these conditions.
  • Organ transplant (e.g., liver)—Use of peginterferon alfa-2b alone or in combination with ribavirin have not been studied in patients with this condition.

Proper Use

A nurse or other trained health professional may give you or your child this medicine. This medicine is given as a shot under your skin. You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

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 doctor.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Pegintron® is available in 2 dosage forms: a vial (glass container) or a prefilled syringe. If you switch from using the vial to using the prefilled syringe, double-check that you are giving yourself the correct amount of medicine.

If you are using this medicine, your doctor will tell you to inject this medicine at bedtime and take medicines (e.g., acetaminophen, Tylenol®) 30 minutes before using this medicine. This helps prevent common "flu-like" symptoms such as fever, chills, headaches, muscle or joint pain, or tiredness. Also, drink extra fluids if you experience these symptoms.

You might not use all of the medicine in each vial (glass container) or prefilled syringe. Use each vial or syringe only one time. Do not save an open vial or syringe. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For hepatitis C virus infection:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 40 and 150 micrograms (mcg) injected under the skin once a week. The medicine should be taken on the same day each week.
      • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    • For hepatitis C virus infection, in combination with ribavirin:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually between 50 and 150 micrograms (mcg) injected under the skin once weekly (same time and day each week) and should be taken together with ribavirin twice daily.
      • Children 3 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 60 microgram per square meter (mcg/m[2]) of body surface area injected under the skin once weekly (same time and day each week) and should be taken together with ribavirin twice daily.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    • For prevention of melanoma:
      • Adults—Dose is based on body weight and must be determined by your doctor. It is usually 6 micrograms (mcg) per kilogram (kg) of body weight injected under the skin per week for 8 doses. This should be followed by 3 mcg/kg of body weight per week injected under the skin for up to 5 years.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store unopened vials of this medicine at room temperature, away from heat and direct light. Do not freeze. An open vial of medicine must be used right away.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine that has been mixed in the refrigerator. You may use it immediately but also may be stored in the refrigerator for 24 hours. Throw away any mixed medicine that has not been used within this time. Do not freeze the solution.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using peginterferon alfa-2b together with ribavirin while you are pregnant can harm your unborn baby. These medicines may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using these medicines, tell your doctor right away.

A negative pregnancy test is needed in women who are of childbearing age before starting treatment with this medicine and ribavirin. Two forms of birth control must be used during treatment and for 6 months after treatment ends. You will need to have pregnancy tests done regularly to make sure you are not pregnant while being treated with these medicines and after your treatment ends.

This medicine can increase thoughts of suicide in people with or without a history of a mental illness. This medicine may also cause relapse in people with a history of substance abuse. Tell your doctor right away if you start to feel more depressed or exhibit aggressive behavior. Also tell your doctor right away if you have thoughts of hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects during treatment and up to 6 months after treatment, tell your doctor or your child's doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of the hands, face, or mouth while you or your child are using this medicine.

Serious allergic reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; fever or chills; hives or welts; red skin lesions; severe acne or skin rash; or sores or ulcers on the skin while you or your child are using this medicine.

Stop using this medicine and check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Peginterferon alfa-2b injection combined with ribavirin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets in the blood, which are necessary for proper blood clotting. If this occurs, there are certain precautions you or your child can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Peginterferon alfa-2b injection when used together with ribavirin may cause teeth and gum problems. These medicines may cause dryness of the mouth, and a dry mouth may damage your teeth and gums if you take these medicines for a long time. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.

Stop using this medicine and check with your doctor right away if you or your child have symptoms that could lead to pancreatitis. This includes sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine when used together with ribavirin may affect your child's growth. Your doctor may need to check your child's height and weight during and after treatment with these medicines.

Peripheral neuropathy may occur if you use this medicine together with telbivudine (Tyzeka®). Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

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 immediately if any of the following side effects occur:

More common

  1. Abdominal or stomach pain
  2. anxiety
  3. black, tarry stools
  4. blood in the urine or stools
  5. bloody diarrhea
  6. chills
  7. cloudy urine
  8. cough or hoarseness
  9. depression
  10. difficult or labored breathing
  11. fever
  12. infection
  13. irritability
  14. lower back or side pain
  15. mood swings
  16. nausea
  17. painful or difficult urination
  18. pale skin
  19. pinpoint red spots on the skin
  20. shortness of breath
  21. tightness in the chest
  22. trouble with sleeping
  23. troubled breathing with exertion
  24. unusual bleeding or bruising
  25. unusual tiredness or weakness
  26. vomiting
  27. wheezing

Less common

  1. Changes in menstrual cycle
  2. constipation
  3. drowsiness
  4. dry hair and skin
  5. sensitivity to cold
  6. weight gain

Rare

  1. Aching, pain, or stiffness in the joints
  2. aggressive behavior
  3. attempt to kill yourself
  4. backache
  5. chest pain (severe)
  6. cool, pale skin
  7. decrease in vision
  8. diarrhea
  9. difficulty with speaking
  10. dizziness
  11. drug addiction or overdose
  12. eye pain
  13. fast or irregular heartbeat
  14. feeling of constant movement of self or surroundings
  15. headache
  16. hives or skin rash
  17. itching of the skin
  18. loss of appetite
  19. muscle weakness
  20. nervousness
  21. numbness or loss of feeling in one or both limbs on the same side of the body
  22. palpitations
  23. paralysis
  24. possible decrease in the amount of urine
  25. restlessness
  26. sensation of spinning
  27. sensitivity to heat
  28. sensitivity to sunlight
  29. sweating (excessive)
  30. thick, scaly skin
  31. thoughts of killing someone
  32. thoughts of killing yourself
  33. warm, smooth, or moist skin
  34. weight loss

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Aching, fullness, or tension in the sinuses
  2. bruising, irritation, or itching at the injection site
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. change in taste
  5. difficulty with moving
  6. flushing of the skin
  7. hair loss
  8. indigestion
  9. loss of taste
  10. muscle pain or stiffness
  11. pain in the bones or muscles
  12. runny nose
  13. sneezing
  14. sore throat
  15. thinning of the hair

Less common

  1. Muscle rigidity or stiffness

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.