•Hemolytic uremic syndrome in the absence of documented infection and resulting in renal insufficiency, electrolyte abnormalities, anemia, and hypertension occurred in two patients following receipt of the first cycle of Unituxin
•Permanently discontinue Unituxin and institute supportive management
•Embryo-Fetal Toxicity
•Unituxin may cause fetal harm
•Advise pregnant women of the potential risk to a fetus
•Advise females of reproductive potential to use effective contraception during treatment, and for two months after the last dose of Unituxin
ADVERSE REACTIONS
The most common adverse drug reactions (greater than or equal to 25%) in Unituxin/RA compared with RA alone are pain (85% vs. 16%), pyrexia (72% vs. 27%), thrombocytopenia (66% vs. 43%), lymphopenia (62% vs. 36%) infusion reactions (60% vs. 9%), hypotension (60% vs. 3%), hyponatremia (58% vs. 12%), increased alanine aminotransferase (56% vs. 31%), anemia (51% vs. 22%), vomiting (46% vs. 19%), diarrhea (43% vs. 15%), hypokalemia (43% vs. 4%), capillary leak syndrome (40% vs. 1%), neutropenia (39% vs. 16%), urticaria (37% vs. 3%), hypoalbuminemia (33% vs. 3%), increased aspartate aminotransferase (28% vs. 7%), and hypocalcemia (27% vs. 0%).
The most common serious adverse reactions (greater than or equal to 5%) are infections, infusion reactions, hypokalemia, hypotension, pain, fever, and capillary leak syndrome.
Please see Full Prescribing Information including Boxed WARNING for Unituxin, available at http://www.unither.com/UFullPrescribingInformation.PDF. |
