RECOMMENDED DOSE IS 3 MG/KG ADMINISTERED INTRAVENOUSLY OVER 90 MINUTES EVERY 3 WEEKS FOR A TOTAL OF 4 DOSES.
DILUTE WITH 0.9% SODIUM CHLORIDE INJECTION, USP OR 5% DEXTROSE INJECTION, USP TO PREPARE A DILUTED SOLUTION WITH A FINAL CONCENTRATION RANGING FROM 1 MG/ML TO 2 MG/ML.
WITHHOLD SCHEDULED DOSE OF IPILIMUMAB FOR ANY MODERATE IMMUNE-MEDIATED ADVERSE REACTIONS OR FOR SYMPTOMATIC ENDOCRINOPATHY. FOR PATIENTS WITH COMPLETE OR PARTIAL RESOLUTION OF ADVERSE REACTIONS (GRADE 0-1), AND WHO ARE RECEIVING LESS THAN 7.5 MG PREDNISONE OR EQUIVALENT PER DAY, RESUME YERVOY AT A DOSE OF 3 MG/KG EVERY 3 WEEKS UNTIL ADMINISTRATION OF ALL 4 PLANNED DOSES OR 16 WEEKS FROM FIRST DOSE, WHICHEVER OCCURS EARLIER.
PERMANENTLY DISCONTINUE IPILIMUMAB FOR ANY OF THE FOLLOWING:
" PERSISTENT MODERATE ADVERSE REACTIONS OR INABILITY TO REDUCE CORTICOSTEROID DOSE TO 7.5 MG PREDNISONE OR EQUIVALENT PER DAY.
" FAILURE TO COMPLETE FULL TREATMENT COURSE WITHIN 16 WEEKS FROM ADMINISTRATION OF FIRST DOSE.
" SEVERE OR LIFE-THREATENING ADVERSE REACTIONS, INCLUDING ANY OF THE FOLLOWING:
" COLITIS WITH ABDOMINAL PAIN, FEVER, ILEUS, OR PERITONEAL SIGNS; INCREASE IN STOOL FREQUENCY (7 OR MORE OVER BASELINE), STOOL INCONTINENCE, NEED FOR INTRAVENOUS HYDRATION FOR MORE THAN 24 HOURS, GASTROINTESTINAL HEMORRHAGE, AND GASTROINTESTINAL PERFORATION
" SGOT, SGPT > 5 TIMES THE UPPER LIMIT OF NORMAL OR TOTAL BILIRUBIN > 3 TIMES THE UPPER LIMIT OF NORMAL
" STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, OR RASH COMPLICATED BY FULL THICKNESS DERMAL ULCERATION, OR NECROTIC, BULLOUS, OR HEMORRHAGIC MANIFESTATIONS
" SEVERE MOTOR OR SENSORY NEUROPATHY, GUILLAIN-BARRΓ SYNDROME, OR MYASTHENIA GRAVIS
" SEVERE IMMUNE-MEDIATED REACTIONS INVOLVING ANY ORGAN SYSTEM (EG, NEPHRITIS, PNEUMONITIS, PANCREATITIS, NON-INFECTIOUS MYOCARDITIS)
" IMMUNE-MEDIATED OCULAR DISEASE THAT IS UNRESPONSIVE TO TOPICAL IMMUNOSUPPRESSIVE THERAPY