inguish between infusion reactions and hypersensitivity reactions in some cases.
•Severe (Grade 3 or 4) infusion reactions occurred in 35 (26%) patients in the Unituxin/13-cis-retinoic acid (RA) group compared to 1 (1%) patient receiving RA alone
•Pain and Peripheral Neuropathy
•Pain: 114 (85%) patients treated in the Unituxin/RA group experienced pain despite pre-treatment with analgesics including morphine sulfate infusion. Severe (Grade 3) pain occurred in 68 (51%) patients in the Unituxin/RA group compared to 5 (5%) patients in the RA group.
•Peripheral Neuropathy: Severe (Grade 3) peripheral sensory neuropathy occurred in 2 (1%) patients and severe peripheral motor neuropathy occurred in 2 (1%) patients in the Unituxin/RA group
•Capillary Leak Syndrome
•Severe (Grade 3 to 5) capillary leak syndrome occurred in 31 (23%) patients in the Unituxin/RA group and in no patients treated with RA alone
•Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin
•Hypotension
•Severe (Grade 3 or 4) hypotension occurred in 22 (16%) patients in the Unituxin/RA group compared to no patients in the RA group
•Prior to each Unituxin infusion, administer required intravenous hydration
•Closely monitor blood pressure during Unituxin treatment
•Depending on severity, manage by immediate interruption, infusion rate reduction or permanent discontinuation of Unituxin
•Infection
•Severe (Grade 3 or 4) bacteremia requiring intravenous antibiotics or other urgent intervention occurred in 17 (13%) patients in the Unituxin/RA group compared to 5 (5%) patients treated with RA alone. Sepsis occurred in 24 (18%) of patients in the Unituxin/RA group and in 10 (9%) patients in the RA group
•Monitor patients closely for signs and symptoms of systemic infection and temporarily discontinue Unituxin in patients who develop systemic infection until resolution of the infection
•Neurological Disorders of the Eye
•Neurological disorders of the eye experienced by two or more patients treated with Unituxin included blurred vision, photophobia, mydriasis, fixed or unequal pupils, optic nerve disorder, eyelid ptosis, and papilledema
•Interrupt Unituxin in patients experiencing dilated pupil with sluggish light reflex or other visual disturbances that do not cause visual loss
•Upon resolution and if continued treatment with Unituxin is warranted, decrease the Unituxin dose by 50%
•Permanently discontinue Unituxin in patients with recurrent eye disorder following dose reduction and in patients who experience loss of vision
•Bone Marrow Suppression
•Severe (Grade 3 or 4) thrombocytopenia (39% vs. 25%), anemia (34% vs. 16%), neutropenia (34% vs. 13%) and febrile neutropenia (4% vs. 0 patients) occurred more commonly in patients in the Unituxin/RA group compared to patients treated with RA alone
•Monitor peripheral blood counts closely during Unituxin therapy
•Electrolyte Abnormalities
•Severe (Grade 3 or 4) hypokalemia and hyponatremia occurred in 37% and 23% of patients in the Unituxin/RA group, respectively, compared to 2% and 4% of patients in the RA group
•Monitor serum electrolytes daily during therapy with Unituxin
•Atypical Hemolytic Uremic Syndrome
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