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

Brand Names : Rebetron

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