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Transcript

((Voice Over))

This video provides a step-by-step guide on how to prepare and administer VYXEOS.

VYXEOS requires reconstitution and further dilution prior to intravenous infusion. For the reconstitution of one VYXEOS vial, you will need a sterile syringe, needle, Sterile Water for Injection, VYXEOS, and an IV bag containing 500 milliliters of either 0.9 percent Sodium Chloride Injection, USP or 5 percent Dextrose Injection, USP. VYXEOS vials should be refrigerated until needed for preparation. VYXEOS is a hazardous drug. Follow applicable special handling and disposal procedures.

VYXEOS contains both daunorubicin and cytarabine at a fixed molar ratio. The calculation to determine the volume of VYXEOS required per dose is based on the dose of daunorubicin. You will then use the patient’s body surface area, or BSA, to complete the calculation. To determine the volume of VYXEOS needed for the dose, multiply the patient’s BSA by the daunorubicin dose, then divide by 2.2 milligrams per milliliter. After reconstitution and prior to dilution, each vial of VYXEOS will contain 20 milliliters for administration. Each milliliter will contain 2.2 milligrams of daunorubicin and 5 milligrams of cytarabine.

Based on the volume required to prepare the dose, remove the appropriate number of VYXEOS vials from the refrigerator.

Let the vials rest for 30 minutes, allowing them to equilibrate to room temperature.

VYXEOS is supplied as a sterile, preservative-free, purple lyophilized cake.

Now that you have completed the setup, you can begin preparing VYXEOS for administration. Once the VYXEOS vials have reached room temperature, withdraw 19 milliliters of Sterile Water for Injection, using aseptic procedures.

Reconstitute VYXEOS with the 19 milliliters of Sterile Water for Injection and immediately start a 5-minute timer.

Begin gently swirling the contents of the vial for 5 minutes, while inverting every 30 seconds. Be sure to continue swirling the vial while it is inverted.

It is very important not to heat, vortex, or shake the vial at any time during this process.

After reconstitution, let the vials rest for 15 minutes.

The reconstituted product should be a purple, opaque, homogeneous dispersion, essentially free from particulates. Use the reconsistuted solution immediately. If needed, store the reconstituted product in the vial refrigerated at 2 degrees Celsius to 8 degrees Celsius, or 36 degrees Fahrenheit to 46 degrees Fahrenheit, for up to 4 hours. Note that the reconstituted product in the vial and the reconstituted product which has been diluted into an infusion solution are stable for a total of 4 hours (not 4 hours each) when stored at 2°C to 8°C.

After the 15-minute rest period, gently invert each vial 5 times for further dilution, then aseptically withdraw the calculated volume of reconstituted product from the vials with a sterile syringe.

Transfer the calculated volume into an infusion bag containing 500 milliliters of 0.9 percent Sodium Chloride Injection, USP or 5 percent Dextrose Injection, USP. Discard any unused portion or residual product remaining in the vial, and do not save any unused portions for later administration.

Gently invert the IV bag to mix the solution.

This process should result in a deep purple, translucent solution. Prior to administration, inspect the solution in the IV bag to ensure that it is a homogeneous dispersion, free from any visible particulates. Only solutions without visible particles should be used. If the diluted infusion solution is not used immediately, store in the refrigerator at 2 degrees Celsius to 8 degrees Celsius, or 36 degrees Fahrenheit to 46 degrees Fahrenheit, for up to 4 hours. If the reconstituted solution in the vial was stored for 4 hours, the diluted infusion solution must be used immediately and cannot be stored for an additional 4 hours.

Administer VYXEOS by constant IV infusion over 90 minutes via an infusion pump through a central venous catheter or a peripherally inserted central catheter. Do not mix VYXEOS with or administer it as an infusion with other drugs.

After administration, flush the line with 0.9 percent Sodium Chloride Injection, USP or 5 percent Dextrose Injection, USP.

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INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

IMPORTANT SAFETY INFORMATION

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

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.

Contraindications

VYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.

Warnings and Precautions

Hemorrhage

Serious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged thrombocytopenia, have occurred with VYXEOS. The overall incidence (grade 1-5) of hemorrhagic events was 74% in the VYXEOS arm and 56% in the control arm. The most frequently reported hemorrhagic event was epistaxis (36% in VYXEOS arm and 18% in control arm). Grade 3 or greater events occurred in 12% of VYXEOS-treated patients and in 8% of patients in the control arm. Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and in 0.7% of patients in the control arm. Monitor blood counts regularly and administer platelet transfusion support as required.

Cardiotoxicity

VYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. This risk may be increased in patients with prior anthracycline therapy, preexisting cardiac disease, previous radiotherapy to the mediastinum, or concomitant use of cardiotoxic drugs. Assess cardiac function prior to VYXEOS treatment and repeat prior to consolidation and as clinically required. Discontinue VYXEOS in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk. VYXEOS is not recommended in patients with cardiac function that is less than normal.

Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m2 have been associated with an increased incidence of drug-induced congestive heart failure. The tolerable limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients whose lifetime anthracycline exposure has reached the maximum cumulative limit.

Hypersensitivity Reactions

Serious or fatal hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. Monitor patients for hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, interrupt or slow the rate of infusion with VYXEOS and manage symptoms. If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat the symptoms, and monitor until symptoms resolve.

Copper Overload

VYXEOS contains copper. Consult with a hepatologist and nephrologist with expertise in managing acute copper toxicity in patients with Wilson’s disease treated with VYXEOS. Monitor total serum copper, serum non-ceruloplasmin-bound copper, 24-hour urine copper levels, and serial neuropsychological examinations during VYXEOS treatment in patients with Wilson’s disease or other copper-related metabolic disorders. Use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.

Tissue Necrosis

Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Confirm patency of intravenous access before administration. Do not administer by intramuscular or subcutaneous route.

Embryo-Fetal Toxicity

VYXEOS can cause embryo-fetal harm when administered to a pregnant woman. Patients should avoid becoming pregnant while taking VYXEOS. If VYXEOS is used during pregnancy or if the patient becomes pregnant while taking VYXEOS, apprise the patient of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (incidence ≥25%) are hemorrhagic events (74%), febrile neutropenia (70%), rash (56%), edema (55%), nausea (49%), mucositis (48%), diarrhea (48%), constipation (42%), musculoskeletal pain (43%), fatigue (39%), abdominal pain (36%), dyspnea (36%), headache (35%), cough (35%), decreased appetite (33%), arrhythmia (31%), pneumonia (31%), bacteremia (29%), chills (27%), sleep disorders (26%), and vomiting (25%).

Please see full Prescribing Information, including BOXED Warning.

INDICATION

VYXEOS is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t‑AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

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.