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(daunorubicin and cytarabine) liposome

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Overview

What is VYXEOS?

VYXEOS (daunorubicin and cytarabine) liposome for injection is a combination of daunorubicin and cytarabine in a 1:5 molar ratio encapsulated in liposomes for intravenous administration. The liposome membrane is composed of distearoylphosphatidylcholine (DSPC), distearoylphosphatidylglycerol (DSPG), and cholesterol in a 7:2:1 molar ratio.

Daunorubicin is an anthracycline topoisomerase inhibitor. The chemical name for daunorubicin is (1S,3S)-3-acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl-3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside; its molecular weight is 527.52. Daunorubicin has the following structural formula:

Cytarabine is a nucleoside metabolic inhibitor. The chemical name of cytarabine is 4-amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone; its molecular weight is 243.22. Cytarabine has the following structural formula:

VYXEOS liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each vial contains 44 mg daunorubicin and 100 mg cytarabine, and the following inactive ingredients: distearoylphosphatidylcholine 454 mg, distearoylphosphatidylglycerol 132 mg, cholesterol HP 32 mg, copper gluconate 100 mg, triethanolamine 4 mg, and sucrose 2054 mg.



What does VYXEOS look like?



What are the available doses of VYXEOS?

For injection: 44 mg daunorubicin and 100 mg cytarabine encapsulated in liposomes as a lyophilized cake in a single-dose vial for reconstitution. ()

What should I talk to my health care provider before I take VYXEOS?

Lactation: Advise not to breastfeed. ()

How should I use VYXEOS?

VYXEOS is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

A full VYXEOS course consists of 1-2 cycles of Induction and up to 2 cycles of Consolidation at the dose and schedule listed in Table 1. Prior to initiating each cycle of VYXEOS, calculate the prior cumulative anthracycline exposure for the patient . Administer prophylactic anti-emetics before treatment with VYXEOS.

For the first cycle of induction, the recommended dose of VYXEOS is (daunorubicin 44 mg/m and cytarabine 100 mg/m) liposome administered via intravenous infusion over 90 minutes on days 1, 3, and 5. Prior to initiating induction, assess cardiac function and obtain liver and renal function studies. For patients who do not achieve remission with the first induction cycle, a second induction cycle may be administered 2 to 5 weeks after the first if there was no unacceptable toxicity with VYXEOS. The recommended dose for the second induction cycle of VYXEOS is (daunorubicin 44 mg/m and cytarabine 100 mg/m) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction. The recommended dose for each cycle of consolidation therapy is VYXEOS (daunorubicin 29 mg/m and cytarabine 65 mg/m) liposome administered via intravenous infusion over 90 minutes on days 1 and 3.

Assess cardiac function, complete blood counts, liver and renal function before each consolidation cycle. Do not start VYXEOS consolidation until the absolute neutrophil count recovers to greater than 0.5 Gi/L and the platelet count recovers to greater than 50 Gi/L in the absence of unacceptable toxicity. Administer the second consolidation cycle 5 to 8 weeks after the start of the first consolidation cycle in patients who do not show disease progression or unacceptable toxicity to VYXEOS.


What interacts with VYXEOS?

Sorry No Records found


What are the warnings of VYXEOS?

Sorry No Records found


What are the precautions of VYXEOS?

Sorry No Records found


What are the side effects of VYXEOS?

Sorry No records found


What should I look out for while using VYXEOS?

The use of VYXEOS is contraindicated in patients with the following:


What might happen if I take too much VYXEOS?

Sorry No Records found


How should I store and handle VYXEOS?

Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures. How SuppliedVYXEOS (daunorubicin and cytarabine) liposome for injection is supplied as a sterile, preservative-free, purple, lyophilized cake, in a single-dose vial. Each VYXEOS vial (NDC 68727-745-01) contains 44 mg daunorubicin and 100 mg cytarabine.NDC 68727-745-02: Carton containing 2 vials of VYXEOSNDC 68727-745-05: Carton containing 5 vials of VYXEOSStorageStore unreconstituted VYXEOS vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position. The vial should be stored in its original carton to protect from light.Handling and DisposalVYXEOS is a cytotoxic drug. Follow applicable special handling and disposal procedures.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

VYXEOS (daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio. The 1:5 molar ratio of daunorubicin:cytarabine has been shown to have synergistic effects at killing leukemia cells in vitro and in murine models. Daunorubicin has antimitotic and cytotoxic activity, which is achieved by forming complexes with DNA, inhibiting topoisomerase II activity, inhibiting DNA polymerase activity, affecting regulation of gene expression, and producing DNA-damaging free radicals. Cytarabine is a cell cycle phase-specific antineoplastic agent, affecting cells only during the S-phase of cell division. Cytarabine acts primarily through inhibition of DNA polymerase. Based on animal data, the liposomes enter and persist in the bone marrow, where they are taken up intact by bone marrow cells. In leukemia-bearing mice, the liposomes are taken up by leukemia cells to a greater extent than by normal bone marrow cells. After cellular internalization, liposomes undergo degradation releasing cytarabine and daunorubicin within the intracellular environment.

Non-Clinical Toxicology
The use of VYXEOS is contraindicated in patients with the following:

Due to substantial differences in the pharmacokinetic parameters, the dose and schedule recommendations for VYXEOS are different from those for 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. Do not substitute other preparations of daunorubicin or cytarabine for VYXEOS.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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