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|Rebetron

RIBAVIRIN AND INTERFERON ALFA-2B, RECOMBINANT (Systemic)

Some commonly used brand names are:

In the U.S.—

• Rebetron

In Canada—

• Rebetron

Description

Ribavirin and interferon alfa-2b ((rye-ba-VYE-rin and in-ter-FEER-on AL-fa) ) combination is used to treat a viral liver infection known as hepatitis C infection. Ribavirin is taken by mouth and interferon alfa-2b is administered beneath the skin (subcutaneously). Ribavirin is used to treat virus infections. Interferons are substances naturally produced by cells in the body to help fight infections and tumors. Interferon alfa-2b is a synthetic (man-made) version of these substances. Interferon alfa-2b is used to treat a variety of tumors and viruses including the hepatitis C virus.

Ribavirin is available for oral administration. Interferon alfa-2b is available only as an injectable form.

Before Using This Medicine

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 ribavirin and interferon alfa-2b combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to alpha interferons or ribavirin.

Pregnancy—Ribavirin should not be used while pregnant, if you plan on becoming pregnant, or by men whose female partners are pregnant.

Breast-feeding—It is not known whether ribavirin or interferon alfa-2b passes into breast milk. However, because these medicines may cause serious side effects, breast-feeding may not be recommended while you are receiving them. Discuss with your doctor whether or not you should breast-feed while you are receiving this combination medicine.

Children—Studies on this combination medicine have been done only in adult patients and there is no specific information comparing use of ribavirin and recombinant interferon alfa-2b combination in children younger than 18 years of age with use in other age group.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ribavirin and interferon alfa-2b combination medicine in the elderly with use in other age group.

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.

Other medical problems—The presence of other medical problems may affect the use of ribavirin and interferon alfa-2b. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, severe or
• Autoimmune hepatitis or
• Bleeding disorders
  —May worsen with ribavirin and/or recombinant interferon alfa-2b

• Diabetes (increased sugar in blood)—May increase the risk of developing eye problems

• Heart disease—May worsen with ribavirin and/or recombinant interferon alfa-2b

• Hepatitis B or human immunodeficiency virus infection or
• Hepatitis C which has worsened or
• Hepatitis C which did not get better when treated with interferon alone—Safety and effectiveness in these conditions are unknown.

• High blood pressure—May increase the risk of developing eye problems

• Kidney problems—May worsen with ribavirin and/or recombinant interferon alfa-2b

• Liver or other organ transplant —Safety and effectiveness in these conditions are unknown.

• Lung problems
  —May worsen with ribavirin and/or recombinant interferon alfa-2b

• Mental problems (or history of)—May result in depression, aggressive, violent and suicidal behavior

• Problem with immune system or
• Psoriasis (inflammatory skin problem) or
• Thyroid problem —May worsen with ribavirin and/or recombinant interferon alfa-2b

• Virus infections, other—Use of ribavirin alone is not recommended

Proper Use of This Medicine

If you are injecting interferon alfa-2b 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.

Interferon alfa-2b often cause unusual tiredness. This effect is less likely to cause problems if you inject this medicine at bedtime. Also, your doctor may want you to drink extra fluids, especially during the early phase of treatment.

Dosing—The dose of ribavirin and interferon alfa-2b will be different for different patients. The dose that is used may depend on a number of things, including the patient"s size and laboratory test. If you are receiving interferon alfa-2b at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of interferons alfa-2b, ask your doctor.

Missed dose—If you miss a dose of ribavirin or interferon alfa-2b, do not inject the missed dose at all and do not double the next one. Check with your doctor for further instructions.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator.
• 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.

Precautions While Using This Medicine

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.

This medicine may cause some people to become unusually tired or dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or if you are not alert.

This medicine may make you feel very sad, depressed or very angry. Call your doctor if you feel you cannot cope or you feel like you want to hurt yourself or someone else.

Interferon alfa-2b commonly causes a flu-like reaction, with aching muscles, fever and chills, and headache. To prevent problems from your temperature going too high, your doctor may ask you to take medicine for pain and fever such as acetaminophen (e.g., Anacin 3, Tylenol) before each dose of interferon alfa-2b. You may also need to take it after a dose to bring your temperature down. Follow your doctor"s instructions carefully about taking your temperature, and how much and when to take the medicine such as acetaminophen .

Women of childbearing potential should use two reliable forms of effective contraception.

Alpha interferon can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid being close to 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 have painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in 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.

Side Effects of This Medicine

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:

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:

.

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

Developed: 10/05/1999
Revised: 05/16/2001

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