RIBAVIRIN AND INTERFERONALFA-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 knownas hepatitis C infection. Ribavirin is taken by mouth and interferon alfa-2bis administered beneath the skin (subcutaneously). Ribavirin is used to treatvirus infections. Interferons are substances naturally produced by cells inthe 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 treata variety of tumors and viruses including the hepatitis C virus.

Ribavirin is available for oral administration. Interferon alfa-2b is availableonly 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 willdo. This is a decision you and your doctor will make. For ribavirin and interferonalfa-2b combination, the following should be considered:

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

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

Breast-feeding?It is not known whether ribavirin or interferonalfa-2b passes into breast milk. However, because these medicines may causeserious side effects, breast-feeding may not be recommended while you arereceiving them. Discuss with your doctor whether or not you should breast-feedwhile you are receiving this combination medicine.

Children?Studies on this combination medicine have beendone only in adult patients and there is no specific information comparinguse of ribavirin and recombinant interferon alfa-2b combination in childrenyounger than 18 years of age with use in other age group.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof ribavirin and interferon alfa-2b combination medicine in the elderly withuse in other age group.

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

Other medical problems?The presence of other medicalproblems may affect the use of ribavirin and interferon alfa-2b. Make sureyou 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 ofdeveloping eye problems

• Heart disease?May worsen with ribavirin and/or recombinantinterferon 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 interferonalone?Safety and effectiveness in these conditions are unknown.

• High blood pressure?May increase the risk of developing eyeproblems

• Kidney problems?May worsen with ribavirin and/or recombinantinterferon alfa-2b

• Liver or other organ transplant ?Safety and effectiveness inthese 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 recombinantinterferon alfa-2b

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

Proper Use of This Medicine

If youare injecting interferon alfa-2b yourself, use it exactlyas directed by your doctor. Do not use more or less of it, and donot use it more often than your doctor ordered. The exact amount of medicineyou need has been carefully worked out. Using too much will increase the riskof side effects, while using too little may not improve your condition.

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

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

Missed dose?If you miss a dose of ribavirin or interferonalfa-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 yourhealth care professional how you should dispose of any medicine you do notuse. 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 atregular visits to make sure that this medicine is working properlyand 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 knowhow you react to this medicine before you drive, use machines, or do anythingelse 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 likeyou 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 temperaturegoing too high, your doctor may ask you to take medicine for pain and feversuch as acetaminophen (e.g., Anacin 3, Tylenol) before each dose of interferonalfa-2b. You may also need to take it after a dose to bring your temperaturedown. Follow your doctor's instructions carefully abouttaking your temperature, and how much and when to take the medicine such asacetaminophen.

Women of childbearing potential should use two reliable forms of effectivecontraception.

Alpha interferon can lower the number of white blood cells in your bloodtemporarily, increasing the chance of getting an infection. It can also lowerthe number of platelets, which are necessary for proper blood clotting. Ifthis occurs, there are certain precautions you can take, especially when yourblood 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 immediatelyif you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine 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 yourteeth and gums. Check with your medical doctor before having any dental workdone
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycould 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 mayneed medical attention.

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

More common

Chest pain; mood changes; trouble breathing; unusual tirednessor weakness

Rare

Thoughts of suicide, attempts at suicide, changes in behavior

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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

More common

Dizziness; fatigue; fever; headache; impairedconcentration; impaired taste; influenza-like symptoms such as unusual tiredness or weakness; irritability; red itchy skin; large swing in moods; loss of appetite; muscle or joint pain; nausea, vomiting, or upset stomach; nervousness; Redness and warm feeling at the site of injection; shaking; temporary thinning of hair; stuffy nose; trouble sleeping

.

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