Pediatric Use Safety and effectiveness of VYXEOS in pediatric patients have not been established. Geriatric Use Of the 375 patients who received VYXEOS (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome in clinical studies, 57% were 65 years and over. No overall differences in safety were observed between these patients and younger patients, with the exception of bleeding events, which occurred more frequently in patients 65 years and older compared to younger patients (77% vs. 59%). Renal Impairment Dosage adjustment is not required for patients with mild (creatinine clearance [CLCR] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]) or moderate (CLCR 30 mL/min to 59 mL/min) renal impairment. VYXEOS has not been studied in patients with severe renal impairment (CLCR 15 mL/min to 29 mL/min) or end-stage renal disease. Hepatic Impairment Dosage adjustment is not required for patients with a bilirubin level less than or equal to 3 mg/dL. VYXEOS has not been studied in patients with bilirubin level greater than 3 mg/dL. PATIENT COUNSELING INFORMATION Hemorrhage Inform patients of the risk of fatal bleeding. Advise patients of the need for periodic monitoring of blood counts and of the importance of keeping scheduled appointments for blood work and necessary transfusions. Advise patients to contact a healthcare provider for new onset fever or symptoms of infection or if they notice signs of bruising or bleeding [see Warnings and Precautions and Adverse Reactions]. Cardiotoxicity Advise patients to contact their healthcare provider if they develop symptoms of heart failure [see Warnings and Precautions]. Hypersensitivity Reactions Inform patients of the risk of hypersensitivity reactions, including anaphylaxis. Describe the symptoms of hypersensitivity reactions, including anaphylaxis, and instruct the patient to seek medical attention immediately if they experience such symptoms [see Warnings and Precautions]. Embryo-Fetal Toxicity VYXEOS can cause fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS and to inform their healthcare provider of a known or suspected pregnancy before and during treatment with VYXEOS [see Warnings and Precautions and Use in Specific Populations]. Lactation Advise patients not to breastfeed during treatment with VYXEOS and for at least 2 weeks after the last dose [see Use in Specific Populations]. Infertility Advise males of reproductive potential that VYXEOS may cause temporary or permanent infertility [see Use in Specific Populations]. Concomitant Medications Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions]. ©2017 Jazz Pharmaceuticals VYX-0083(1) Rev0817