ASH Clinical News ACN_4.14_Full Issue_web | Page 39

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/m 2
and cytarabine 100 mg/m 2 ) 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 [CL CR ] 60 mL/min to 89 mL/min by Cockcroft Gault equation
[C-G]) or moderate (CL CR 30 mL/min to 59 mL/min) renal impairment.
VYXEOS has not been studied in patients with severe renal impairment
(CL CR 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].
©2018 Jazz Pharmaceuticals
VYX-0083(2)
Rev0818