Clinical use:
Pediatrics (<18 years): The safety and effectiveness of VYXEOS in the treatment of newly diagnosed t-AML and AML-MRC has not been established in children and adolescent patients under 18 years of age.
Geriatrics (≥65 years of age): No significant differences in safety were observed in patients aged 65 or older.
Serious warnings and precautions: VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.
Relevant warnings and precautions:
- VYXEOS must not be substituted or interchanged with other daunorubicin and/or cytarabine-containing products
- Tissue necrosis
- Cardiotoxicity is a known risk of anthracycline treatment
- Driving and operating machinery
- VYXEOS should be used in patients with a history of Wilson’s disease or other copper-related disorder only if the benefits outweigh the risks. Discontinue VYXEOS in patients with signs or symptoms of acute copper toxicity
- Gastrointestinal mucositis and diarrhea
- Hematologic: Severe myelosuppression resulting in fatal infections and hemorrhage has been reported in patients after administration with VYXEOS. Patient blood counts should be regularly monitored during VYXEOS treatment and appropriate supportive measures should be used for clinical complications due to myelosuppression
- Hepatic impairment may increase the risk of toxicity associated with daunorubicin and cytarabine. Evaluation of hepatic function using conventional clinical laboratory tests is recommended prior to administration of VYXEOS and periodically during treatment. VYXEOS should only be used in patients with severe hepatic impairment if the benefits outweigh the risks
- Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine
- Renal impairment may increase the risk of toxicity associated with daunorubicin and cytarabine. Evaluation of renal function using conventional clinical laboratory tests is recommended prior to administration of VYXEOS and periodically during treatment. VYXEOS should only be used in patients with end-stage renal disease if the benefits outweigh the risks
- Increased susceptibility to infections
- Cardiac function and blood uric acid levels should be closely monitored. Appropriate therapy should be initiated if hyperuricemia develops
- Pregnancy: There are no data on the use of VYXEOS in pregnant women. Patients should be advised to avoid becoming pregnant during VYXEOS treatment. Male patients and women of childbearing potential must use effective methods of contraception during treatment and for 6 months following last dose of VYXEOS
- Male fertility may be compromised by treatment with VYXEOS according to animal studies
- Nursing women should be advised not to breastfeed during treatment with VYXEOS
For more information:
Consult the VYXEOS Product Monograph at: www.jazzpharma.com for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece.
The Product Monograph is also available by calling our medical department at 1-800-520-5568