IntronA-Interferon alfa-2b

Patient Education Quick Reference Guide Diablo Valley Oncology/Hematology Medical Group Phone Number: 925-677-5041

What is INTRON® A?

  • The INTRON A product contains a man-made protein called interferon. Interferon is a protein that is part of the body’s immune system that “interferes” with the growth of viruses or cancer cells.
  • It is not known if INTRON A or INTRON A/REBETOL® combination therapy can cure hepatitis B or C (permanently eliminate the virus) or if it can prevent liver failure or liver cancer that is caused by hepatitis B or C infection.
  • It is also not known if INTRON A or INTRON A/REBETOL combination therapy will prevent one infected person from infecting another person with hepatitis B or C.

Who Should Not Take INTRON® A?

Do not take INTRON A alone or in combination with REBETOL® if you:
  • are pregnant, planning to get pregnant, or breastfeeding
  • are a male patient on combination therapy and have a female sexual partner who is pregnant or plans to become pregnant while you are being treated with REBETOL or during the 6 months after your treat- ment has ended
  • have autoimmune hepatitis (hepatitis caused by your immune system attacking your liver) or unstable liver disease (yellowing of the skin and eyes, swelling of the abdomen)
  • had an allergic reaction to another alpha interferon or ribavirin or are allergic to any of the ingredients in INTRON A or REBETOL If you have any of the following conditions or serious medical problems, tell your health care provider before taking INTRON A alone or in combi- nation with REBETOL:
  • depression or anxiety
  • eye problems
  • sleep problems
  • high blood pressure
  • previous heart attack, or other heart problems
  • liver problems (other than hepatitis B or C)
  • any kind of autoimmune disease (where the body’s immune system attacks the body’s own cells), such as psoriasis, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis
  • thyroid problems
  • diabetes
  • colitis (inflammation of the bowels)
  • cancer
  • hepatitis B or C infection
  • HIV infection (the virus that causes AIDS)
  • kidney problems
  • bleeding problems
  • alcoholism
  • drug abuse or addiction
  • body organ transplant and are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system)
  • high blood triglycerides (fat particles normally found in your blood)
Tell your health care provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supple- ments. INTRON A and certain other medicines may affect each other and cause side effects. Especially tell your doctor if you take the anti-hepatitis B medicine telbivudine (Tyzeka®). See “What are the possible side effects of INTRON A?”  

How should I take INTRON® A?

To get the most benefit from this medicine, it is important that you take INTRON A exactly as your health care provider tells you. Your health care provider will decide your dose of INTRON A and how often you will take it.
  • Do not take more than your prescribed dose.
  • INTRON A is given as an injection either under the skin (subcutaneous) or into a muscle (intramuscular).
  • You should be completely comfortable with how to prepare and measure your dose of INTRON A and how to inject yourself before you use INTRON A for the first time. Your health care provider will train you on how to use and inject INTRON A properly.
  • INTRON A comes in different strengths and different forms (a powder in a vial, a solution in a vial, and a multidose pen). Your health care provider will determine which form is best for you. The instructions for giving a dose of INTRON A are in the downloadable medication sheet.

What do I do if I Miss a Dose?

  • If you miss a dose of INTRON A, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule.
  • If several days go by after you miss a dose, check with your health care provider to see what to do.
  • Do not double your next dose or take more than your prescribed dose without talking to your health care provider.
  • Call your health care provider right away if you take more than your prescribed dose. Your health care provider may wish to examine you more closely and take blood for testing.

If Taken in Combination with REBETOL®

  • If you are taking INTRON A in combination with REBETOL®, you should also read the Medication Guide for REBETOL (ribavirin, USP) for more information about side effects and how to take REBETOL.
  • REBETOL capsules should be taken twice a day with food. Taking REBETOL with food helps your body take up more of the medicine.
  • Taking REBETOL at the same time of day every day will help keep the amount of medicine in your body at a steady level. This can help your health care provider decide how your treatment is working and how to change the number of REBETOL capsules you take if you have side effects.
  • If you miss a dose of REBETOL, take the missed dose as soon as possible during the same day. If an entire day has passed, check with your health care provider about what to do. Do not double your next dose.
  • You must see your health care provider on a regular basis for blood tests so your health care provider can check how the treatment is working for you and to check for side effects.
  • Tell your health care provider if you are taking or planning to take other prescription or nonprescription medicines, including vitamin and mineral supplements and herbal medicines.

What Should I Avoid While Taking INTRON® A?

  • Avoid becoming pregnant while taking INTRON A. INTRON A alone and INTRON A taken in combination with REBETOL® may harm your unborn child or cause you to lose your baby (miscarry). If you or your partner becomes pregnant during treatment or during the 6 months after treatment with INTRON A/REBETOL combination therapy, immediately report the pregnancy to your health care provider. Your health care provider will make decisions about your treatment. Your health care provider should call 1-800-593-2214. Your health care provider will be asked to give follow-up information about the pregnancy.
  • Do not breastfeed your baby while taking INTRON A.

What is the Most Important Information I Should Know About INTRON® A?

  • INTRON A is a treatment for some people who have hairy cell leukemia, malignant melanoma, follicular lymphoma, AIDS-related Kaposi’s sarcoma, chronic hepatitis B, chronic hepatitis C, and condylomata acuminata. If you have chronic hepatitis C, your health care provider may prescribe INTRON A in combination with REBETOL®. INTRON A used by itself or with REBETOL can help you, but can also have serious side effects and may cause death in rare cases.
  • Before starting treatment, you should talk to your health care provider about the possible benefits and possible side effects of INTRON A alone or in combination with REBETOL, to decide if this treat-ment is right for you.
  • While taking INTRON A alone or in combination with REBETOL, you need to see a health care provider regularly for medical examinations and lab tests to make sure the treatment is working and to check for side effects.
 

When Should I Call My Health Care Provider?

You should call your health care provider immediately if you develop any of these conditions while taking INTRON A:
  • you become pregnant or if you are a male and your female partner becomes pregnant
  • new or worsening mental health problems such as thoughts about hurting or killing yourself or others
  • decreased vision
  • trouble breathing or chest pain
  • severe stomach or lower back pain
  • bloody diarrhea or bloody bowel movements
  • high fever
  • easy bruising or bleeding
 

Side Effects

The most serious possible side effects of INTRON A include:

RISK TO PREGNANCY

  • Combination INTRON A and REBETOL therapy can cause death, serious birth defects or other harm to your unborn child. If you are pregnant, you or your male partner must not take INTRON A and REBETOL combination therapy.
  • You must not become pregnant while either you or your partner are taking the combination of INTRON A and REBETOL and for 6 months after you stop taking the combination. If you are a woman of childbearing age you must have negative pregnancy tests immediately before starting treatment, during treatment, and for 6 months after you have stopped treatment. You should use two forms of birth con- trol during and for 6 months after you have stopped treatment.
  • If you are a man taking INTRON A/REBETOL combination therapy, one of the two forms of birth control should be a condom. You must use birth control even if you believe that you are not fertile or that your fertility is low. You should talk to your health care provider about birth control for you and your partner.
  • If you or your partner becomes pregnant while either of you is being treated or within 6 months of stopping treatment, tell your health care provider right away. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes in female patients and female partners of male patients exposed to ribavirin. You or your health care provider are encouraged to contact the Registry at 1-800-593-2214.
  Mental health problems and suicide
  • INTRON A may cause patients to develop mood or behavioral problems. These can include irritability (get- ting easily upset) and depression (feeling low, feeling bad about yourself, or feeling hopeless).
  • Some patients may have aggressive behavior.
  • Former drug addicts may fall back into drug addiction or overdose.
  • Some patients think about hurting or killing themselves or other people. Some patients have killed themselves (suicide) or hurt themselves or others.
  • You must tell your health care provider if you are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior. You should also tell your health care provider if you have ever been addicted to drugs or alcohol.
 

Eye problems

  • Changes in vision such as a decrease or loss of vision (blindness) may happen in some patients.
  • You should have an eye exam before you take INTRON A. If you have eye problems or have had them in the past, you may need eye exams while you are taking INTRON A.
  • Tell your health care provider or eye doctor right away if you have changes in your vision while taking INTRON A.
 

Heart problems

  • Some patients taking INTRON A may develop problems with their heart, including low blood pressure, fast heart rate, and very rarely, heart attacks.
  • Tell your health care provider if you have had any heart problems in the past.
  Blood problems
  • INTRON A commonly lowers two types of blood cells (white blood cells and platelets). In some patients, these blood counts may fall to dangerously low levels. If your blood cell counts become very low, you could get infections or have bleeding problems.
  • If you are taking INTRON A and REBETOL combination therapy, REBETOL can cause a drop in your number of red blood cells (anemia). A very low red blood cell count can be dangerous, especially if you have heart or breathing problems.
  • For other possible side effects of INTRON A, see “What are the possible side effects of INTRON A?” in this Medication Guide.
 

Body organ problems

  • INTRON A may cause lung problems including: trouble breathing, pneumonia, inflammation of lung tissue, and new or worse high blood pressure of the lungs (pulmonary hypertension), which can be severe and may in some cases lead to death.
  • Certain symptoms like severe stomach pain may mean that your internal organs are being damaged.
  • Cases of weakness, loss of coordination, and numbness due to stroke have been reported in patients taking INTRON A, including patients with few or no reported risk factors for stroke.
 

What Are Other Possible Side Effects of INTRON® A?

Also see “What is the most important information I should know about INTRON A?” INTRON A may cause serious side effects including:

Other body organ problems

Certain symptoms like severe pain in the middle of your body, nausea, and vomiting may mean that your liver or pancreas is being damaged. A few patients have inflammation of the kidney. If you have severe stomach or back pains or a fever, you should call your health care provider right away.

Thyroid problems

Some patients develop changes in the function of their thyroid. Symptoms of thyroid changes include the inability to concentrate, feeling cold or hot all the time, a change in your weight, and changes to your skin.

New or worsening autoimmune disease

Some patients taking INTRON A develop autoimmune diseases (a condition where the body’s immune cells attack other cells or organs in the body), including rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis, and psoriasis. In some patients who already have an autoimmune disease, the disease may worsen while on INTRON A.

Nerve problems

People who take INTRON A or other alpha interferon products with telbivudine (Tyzeka®) can have nerve problems such as continuing numbness, tingling, or burning sensation in the arms or legs (peripheral neuropathy). Call your health care provider if you have any of these symptoms.

Common but less serious side effects include:

  • Flu-like symptoms: Most patients who take INTRON A have flu-like symptoms (headache, muscle aches, tiredness, and fever) that usually lessen after the first few weeks of therapy. You can reduce some of these symptoms by injecting your INTRON A dose at bedtime. Over- the-counter pain and fever medications can be used to prevent or reduce the fever and headache. If your fever does not go away you should tell your health care provider.
  • Extreme fatigue (tiredness): Many patients become extremely tired while on INTRON A.
  • Appetite problems: Nausea, loss of appetite, and weight loss occur commonly.
  • Blood sugar problems: Some patients develop problems with the way their body controls their blood sugar and may develop high blood sugar or diabetes.
  • Skin reactions: Redness, swelling, and itching are common at the site of injection. If after several days these symptoms do not disappear, contact your health care provider. You may get a rash during therapy. If this occurs, your health care provider may recommend medicine to treat the rash.
  • Hair thinning: Hair thinning is common during INTRON A treatment. Hair loss stops and hair growth returns after therapy is stopped.
  These are not all the side effects of INTRON A or INTRON A/REBETOL® com- bination therapy. Your health care provider can give you a more complete list. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

General Advice About Prescription Medicines

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • If you have any concerns about the INTRON® A product, ask your health care provider.
  • Your health care provider can give you additional information about INTRON A.
  • Do not use INTRON A for a condition for which it was not prescribed.
  • Do not share this medication with other people.
  • Keep a list of the medicines that you take and show it to your health care provider and pharmacist when you get a new medicine.