HALAVEN IS INDICATED FOR THE TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER WHO HAVE PREVIOUSLY RECEIVED AT LEAST TWO CHEMOTHERAPEUTIC REGIMENS FOR THE TREATMENT OF METASTATIC DISEASE. PRIOR THERAPY SHOULD HAVE INCLUDED AN ANTHRACYCLINE AND A TAXANE IN EITHER THE ADJUVANT OR METASTATIC SETTING.
THE RECOMMENDED DOSE OF HALAVEN IS 1.4 MG/M² ADMINISTERED INTRAVENOUSLY OVER 2 TO 5 MINUTES ON DAYS 1 AND 8 OF A 21-DAY CYCLE.
THE RECOMMENDED DOSE OF HALAVEN IN PATIENTS WITH MILD HEPATIC IMPAIRMENT (CHILD-PUGH A) IS 1.1 MG/M² ADMINISTERED INTRAVENOUSLY OVER 2 TO 5 MINUTES ON DAYS 1 AND 8 OF A 21-DAY CYCLE.
THE RECOMMENDED DOSE OF HALAVEN IN PATIENTS WITH MODERATE HEPATIC IMPAIRMENT (CHILD-PUGH B) IS 0.7 MG/M² ADMINISTERED INTRAVENOUSLY OVER 2 TO 5 MINUTES ON DAYS 1 AND 8 OF A 21-DAY CYCLE.
THE RECOMMENDED DOSE OF HALAVEN IN PATIENTS WITH MODERATE RENAL IMPAIRMENT (CREATININE CLEARANCE OF 30-50 ML/MIN) IS 1.1 MG/M² ADMINISTERED INTRAVENOUSLY OVER 2 TO 5 MINUTES ON DAYS 1 AND 8 OF A 21-DAY CYCLE.
DOSE MODIFICATION
ASSESS FOR PERIPHERAL NEUROPATHY AND OBTAIN COMPLETE BLOOD CELL COUNTS PRIOR TO EACH DOSE.
RECOMMENDED DOSE DELAYS
DO NOT ADMINISTER HALAVEN ON DAY 1 OR DAY 8 FOR ANY OF THE FOLLOWING:
ANC < 1,000/MM³
PLATELETS < 75,000/MM³
GRADE 3 OR 4 NON-HEMATOLOGICAL TOXICITIES.
THE DAY 8 DOSE MAY BE DELAYED FOR A MAXIMUM OF 1 WEEK.
IF TOXICITIES DO NOT RESOLVE OR IMPROVE TO = GRADE 2 SEVERITY BY DAY 15, OMIT THE DOSE.
IF TOXICITIES RESOLVE OR IMPROVE TO = GRADE 2 SEVERITY BY DAY 15, ADMINISTER HALAVEN AT A REDUCED DOSE AND INITIATE THE NEXT CYCLE NO SOONER THAN 2 WEEKS LATER.
RECOMMENDED DOSE REDUCTIONS
IF A DOSE HAS BEEN DELAYED FOR TOXICITY AND TOXICITIES HAVE RECOVERED TO GRADE 2 SEVERITY OR LESS, RESUME HALAVEN AT A REDUCED DOSE AS SET OUT IN TABLE 1.
DO NOT RE-ESCALATE HALAVEN DOSE AFTER IT HAS BEEN REDUCED.
TABLE 1 : RECOMMENDED DOSE REDUCTIONS
EVENT DESCRIPTION
RECOMMENDED HALAVEN DOSE
PERMANENTLY REDUCE THE 1.4 MG/M² HALAVEN DOSE FOR ANY OF THE FOLLOWING:
ANC < 500/MM³ FOR > 7 DAYS
ANC < 1,000 /MM³ WITH FEVER OR INFECTION
PLATELETS < 25,000/MM³
1.1 MG/M²
PLATELETS < 50,000/MM³ REQUIRING TRANSFUSION
NON-HEMATOLOGIC GRADE 3 OR 4 TOXICITIES
OMISSION OR DELAY OF DAY 8 HALAVEN DOSE IN PREVIOUS CYCLE FOR TOXICITY
OCCURRENCE OF ANY EVENT REQUIRING PERMANENT DOSE REDUCTION WHILE RECEIVING 1.1 MG/M²
0.7 MG/M²
OCCURRENCE OF ANY EVENT REQUIRING PERMANENT DOSE REDUCTION WHILE RECEIVING 0.7 MG/M²
DISCONTINUE HALAVEN
ANC = ABSOLUTE NEUTROPHIL COUNT.