Combination REBETOL/ INTRON A therapy must not be used by women who are pregnant or by men whose female partners are pregnant. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients taking combination REBETOL/ INTRON A therapy. Combination REBETOL/ INTRON A therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Patients must perform a pregnancy test monthly during therapy and for 6 months posttherapy. Women of childbearing potential must be counseled about use of effective contraception (two reliable forms) prior to initiating therapy. Patients (male and female) must be advised of the teratogenic/ embryocidal risks and must be instructed to practice effective contraception during combination REBETOL/ INTRON A therapy and for 6 months posttherapy. Patients (male and female) should be advised to notify the physician immediately in the event of a pregnancy. (See CONTRAINDICATIONS. )

If pregnancy does occur during treatment or during 6 months posttherapy, the patient must be advised of the significant teratogenic risk of REBETOL therapy to the fetus. Patients, or partners of patients, should immediately report any pregnancy that occurs during treatment or within 6 months after treatment cessation to their physician. Physicians are encouraged to report such cases by calling (800) 727- 7064.

Patients receiving combination REBETOL/ INTRON A treatment should be directed in its appropriate use, informed of the benefits and risks associated with treatment, and referred to the patient MEDICATION GUIDE . There are no data evaluating whether REBETOL/ INTRON A therapy will prevent transmission of infection to others. Also, it is not known if treatment with REBETOL/ INTRON A therapy will cure hepatitis C or prevent cirrhosis, liver failure, or liver cancer that may be the result of infection with the hepatitis C virus.

If home use is prescribed, a puncture-resistant container for the disposal of used syringes and needles should be supplied to the patient. Patients should be thoroughly instructed in the importance of proper disposal and cautioned against any reuse of needles and syringes. The full container should be disposed of according to the directions provided by the physician (see MEDICATION GUIDE ).

The most common adverse experiences occurring with combination REBETOL/ INTRON A therapy are "flu-like" symptoms, such as headache, fatigue, myalgia, and fever (see ADVERSE REACTIONS ) and appear to decrease in severity as treatment continues. Some of these "flu-like" symptoms may be minimized by bedtime administration of INTRON A therapy. Antipyretics should be considered to prevent or partially alleviate the fever and headache. Another common adverse experience associated with INTRON A therapy is thinning of the hair.

Patients should be advised that laboratory evaluations are required prior to starting therapy and periodically thereafter (see PRECAUTIONS: Laboratory Tests). It is advised that patients be well hydrated, especially during the initial stages of treatment.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.