CHRONIC HEPATITIS C:
THE RECOMMENDED DOSAGE OF INTERFERON ALFA-2A, RECOMBINANT FOR THE TREATMENT OF CHRONIC HEPATITIS C IS 3 MIU THREE TIMES A WEEK (TIW) ADMINISTERED SUBCUTANEOUSLY FOR 12 MONTHS (48 TO 52 WEEKS). AS AN ALTERNATIVE, PATIENTS MAY BE TREATED WITH AN INDUCTION DOSE OF 6 MIU TIW FOR THE FIRST 3 MONTHS (12 WEEKS) FOLLOWED BY 3 MIU TIW FOR 9 MONTHS (36 WEEKS).
PATIENTS WHO TOLERATE AND PARTIALLY OR COMPLETELY RESPOND TO THERAPY WITH INTERFERON ALFA-2A, RECOMBINANT BUT RELAPSE FOLLOWING ITS DISCONTINUATION MAY BE RE-TREATED. RE-TREATMENT WITH EITHER 3 MIU TIW OR WITH 6 MIU TIW FOR 6 TO 12 MONTHS MAY BE CONSIDERED.
TEMPORARY DOSE REDUCTION BY 50% IS RECOMMENDED IN PATIENTS WHO DO NOT TOLERATE THE PRESCRIBED DOSE. IF ADVERSE EVENTS RESOLVE, TREATMENT WITH THE ORIGINAL PRESCRIBED DOSE CAN BE RE-INITIATED.
CHRONIC MYELOGENOUS LEUKEMIA:
FOR PATIENTS WITH PH-POSITIVE (PHILADELPHIA CHROMOSOME POSITIVE) CML IN CHRONIC PHASE :
RECOMMENDED INITIAL DOSE OF INTERFERON ALFA-2A, RECOMBINANT IS 9 MIU DAILY ADMINISTERED AS A SUBCUTANEOUS INJECTION. BASED ON CLINICAL EXPERIENCE, SHORT-TERM TOLERANCE MAY BE IMPROVED BY GRADUALLY INCREASING THE DOSE OF INTERFERON ALFA-2A, RECOMBINANT OVER THE FIRST WEEK OF ADMINISTRATION FROM 3 MIU DAILY FOR 3 DAYS TO 6 MIU DAILY FOR 3 DAYS TO THE TARGET DOSE OF 9 MIU DAILY FOR THE DURATION OF THE TREATMENT PERIOD.
MONITORING OF HEMATOLOGIC PARAMETERS SHOULD BE DONE REGULARLY (E.G., MONTHLY). SINCE SIGNIFICANT CYTOGENETIC CHANGES ARE NOT READILY APPARENT UNTIL AFTER HEMATOLOGIC RESPONSE HAS OCCURRED, AND USUALLY NOT UNTIL SEVERAL MONTHS OF THERAPY HAVE ELAPSED.
HAIRY CELL LEUKEMIA:
PRIOR TO INITIATION OF THERAPY, TESTS SHOULD BE PERFORMED TO QUANTITATE PERIPHERAL BLOOD HEMOGLOBIN, PLATELETS, GRANULOCYTES AND HAIRY CELLS AND BONE MARROW HAIRY CELLS. THESE PARAMETERS SHOULD BE MONITORED PERIODICALLY (E.G., MONTHLY) DURING TREATMENT. IF A PATIENT DOES NOT RESPOND WITHIN 6 MONTHS, TREATMENT SHOULD BE DISCONTINUED. PATIENTS WITH HAIRY CELL LEUKEMIA HAVE BEEN TREATED FOR UP TO 24 CONSECUTIVE MONTHS. THE OPTIMAL DURATION OF TREATMENT FOR THIS DISEASE HAS NOT BEEN DETERMINED.
THE INDUCTION DOSE OF INTERFERON ALFA-2A, RECOMBINANT IS 3 MIU DAILY FOR 16 TO 24 WEEKS, ADMINISTERED AS A SUBCUTANEOUS INJECTION. THE RECOMMENDED MAINTENANCE DOSE IS 3 MIU, TIW. DOSE REDUCTION BY ONE-HALF OR WITHHOLDING OF INDIVIDUAL DOSES MAY BE NEEDED WHEN SEVERE ADVERSE REACTIONS OCCUR. THE USE OF DOSES HIGHER THAN 3 MIU IS NOT RECOMMENDED IN HAIRY CELL LEUKEMIA.