1. IT IS INDICATED FOR USE FOLLOWING INDUCTION CHEMOTHERAPY IN OLDER ADULT PATIENTS WITH ACUTE MYELOGENOUS LEUKEMIA (AML) TO SHORTEN TIME TO NEUTROPHIL RECOVERY AND TO REDUCE THE INCIDENCE OF SEVERE AND LIFE-THREATENING INFECTIONS AND INFECTIONS RESULTING IN DEATH.
THE RECOMMENDED DOSE IS 250MCG/M²/DAY ADMINISTERED INTRAVENOUSLY OVER A 4 HOUR PERIOD STARTING APPROXIMATELY ON DAY 11 OR FOUR DAYS FOLLOWING THE COMPLETION OF INDUCTION CHEMOTHERAPY, IF THE DAY 10 BONE MARROW IS HYPOPLASTIC WITH < 5% BLASTS. IF A SECOND CYCLE OF INDUCTION CHEMOTHERAPY IS NECESSARY, LEUKINE SHOULD BE ADMINISTERED APPROXIMATELY FOUR DAYS AFTER THE COMPLETION OF CHEMOTHERAPY IF THE BONE MARROW IS HYPOPLASTIC WITH < 5% BLASTS. LEUKINE SHOULD BE CONTINUED UNTIL AN ANC > 1500 CELLS/MM³ FOR 3 CONSECUTIVE DAYS OR A MAXIMUM OF 42 DAYS. LEUKINE SHOULD BE DISCONTINUED IMMEDIATELY IF LEUKEMIC REGROWTH OCCURS. IF A SEVERE ADVERSE REACTION OCCURS, THE DOSE CAN BE REDUCED BY 50% OR TEMPORARILY DISCONTINUED UNTIL THE REACTION ABATES.
2. USE IN MYELOID RECONSTITUTION AFTER AUTOLOGOUS BONE MARROW TRANSPLANTATION
3. INDICATED FOR THE MOBILIZATION OF HEMATOPOIETIC PROGENITOR CELLS INTO PERIPHERAL BLOOD FOR COLLECTION BY LEUKAPHERESIS.
THE RECOMMENDED DOSE IS 250 MCG/M²/DAY ADMINISTERED IV OVER 24 HOURS OR SC ONCE DAILY. DOSING SHOULD CONTINUE AT THE SAME DOSE THROUGH THE PERIOD OF PBPC COLLECTION. THE OPTIMAL SCHEDULE FOR PBPC COLLECTION HAS NOT BEEN ESTABLISHED. IN CLINICAL STUDIES, COLLECTION OF PBPC WAS USUALLY BEGUN BY DAY 5 AND PERFORMED DAILY UNTIL PROTOCOL SPECIFIED TARGETS WERE ACHIEVED. IF WBC > 50,000 CELLS/MM³, THE LEUKINE DOSE SHOULD BE REDUCED BY 50%. IF ADEQUATE NUMBERS OF PROGENITOR CELLS ARE NOT COLLECTED, OTHER MOBILIZATION THERAPY SHOULD BE CONSIDERED.
4. POST PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION
THE RECOMMENDED DOSE IS 250 MCG/M²/DAY ADMINISTERED IV OVER 24 HOURS OR SC ONCE DAILY BEGINNING IMMEDIATELY FOLLOWING INFUSION OF PROGENITOR CELLS AND CONTINUING UNTIL AN ANC > 1500 CELLS/MM³ FOR THREE CONSECUTIVE DAYS IS ATTAINED.
5. USE IN MYELOID RECONSTITUTION AFTER ALLOGENEIC OR AUTOLOGOUS BONE MARROW TRANSPLANTATION
THE RECOMMENDED DOSE IS 250MCG/M²/DAY ADMINISTERED IV OVER A 2-HOUR PERIOD BEGINNING TWO TO FOUR HOURS AFTER BONE MARROW INFUSION, AND NOT LESS THAN 24 HOURS AFTER THE LAST DOSE OF CHEMOTHERAPY OR RADIOTHERAPY. PATIENTS SHOULD NOT RECEIVE LEUKINE UNTIL THE POST MARROW INFUSION ANC IS LESS THAN 500 CELLS/MM³. LEUKINE SHOULD BE CONTINUED UNTIL AN ANC > 1500 CELLS/MM³ FOR THREE CONSECUTIVE DAYS IS ATTAINED. IF A SEVERE ADVERSE REACTION OCCURS, THE DOSE CAN BE REDUCED BY 50% OR TEMPORARILY DISCONTINUED UNTIL THE REACTION ABATES. LEUKINE SHOULD BE DISCONTINUED IMMEDIATELY IF BLAST CELLS APPEAR OR DISEASE PROGRESSION OCCURS.
6. USE IN BONE MARROW TRANSPLANTATION FAILURE OR ENGRAFTMENT DELAY
THE RECOMMENDED DOSE IS 250 MCG/M²/DAY FOR 14 DAYS AS A 2-HOUR IV INFUSION. THE DOSE CAN BE REPEATED AFTER 7 DAYS OFF THERAPY IF ENGRAFTMENT HAS NOT OCCURRED. IF ENGRAFTMENT STILL HAS NOT OCCURRED, A THIRD COURSE OF 500 MCG/M²/DAY FOR 14 DAYS MAY BE TRIED AFTER ANOTHER 7 DAYS OFF THERAPY. IF THERE IS STILL NO IMPROVEMENT, IT IS UNLIKELY THAT FURTHER DOSE ESCALATION WILL BE BENEFICIAL. IF A SEVERE ADVERSE REACTION OCCURS, THE DOSE CAN BE REDUCED BY 50% OR TEMPORARILY DISCONTINUED UNTIL THE REACTION ABATES. LEUKINE SHOULD BE DISCONTINUED IMMEDIATELY IF BLAST CELLS APPEAR OR DISEASE PROGRESSION OCCURS.
7. USE IN PATIENTS RECEIVING PURGED BONE MARROW