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Transcript

((Voice Over))
Welcome to the presentation titled “VYXEOS® (daunorubicin and cytarabine) Dosing & Administration.”

VYXEOS is indicated for the treatment of adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes.

VYXEOS has different dosage recommendations than other daunorubicin and cytarabine-containing products. Do not interchange with products containing these ingredients.

Do not use in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin or any other components of VYXEOS.

This segment is presented by Sara Tinsley, a nurse practitioner from the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida. She will be reviewing the dosing and administration of VYXEOS, the first chemotherapy approved for adults with newly-diagnosed t-AML, therapy-related acute myeloid leukemia or AML-MRC, acute myeloid leukemia with myelodysplasia-related changes.

((Sara M. Tinsley, PhD, ARNP, AOCN))

So, how do you give VYXEOS?

VYXEOS and 7+3 are administered differently. VYXEOS is given on…

…Days 1, 3 and 5; and 7+3, as you know, the cytarabine is given as a 7-day continuous infusion where the patient is connected to the IV that entire time; and they're usually in the hospital; and then they get 3 days of 15-minutes bolus of the daunorubicin. And then you can see the second inductions, how they compare there.

And then for consolidation, there's only 2 days of infusion center or inpatient for VYXEOS -- Days 1 and 3; and for 5+2 in this study, you can see how those are graphed there.

And in the Phase 3 trial, 51% of the patients received VYXEOS in an outpatient setting during their consolidation.

And premedication in the Phase 3 trial was allowed for nausea and vomiting per institutional protocol.

This was on the prior slide -- just the dosing of the daunorubicin and cytarabine, 44 milligrams per meter squared for daunorubicin, and a hundred milligrams per meter squared for cytarabine during the first induction given on Days 1, 3 and 5.

You want to pay attention to that far right-hand corner; it gives you the cumulative doses, and those are important when we're calculating the total anthracycline dose, especially in our therapy-related cases where people have had prior radiation to the sternum, or prior…

…anthracycline for breast cancer.

It's supplied in a single-dose vial containing 44 mg of daunorubicin and a hundred mg of cytarabine. So, prior to you starting that first cycle, you want to calculate the patient's prior anthracycline exposure for your therapy-related AMLs. You want to look at…

…their cardiac function; typically we do an echo or a MUGA. You want to look at the complete blood cell count like we always do; the chemistry profile that has your hepatic and renal function tests in them; and you don't want to start the consolidation until the absolute neutrophil count reaches 500, and the platelet count recovers to greater than 50,000.

And normally, the consolidation is administered approximately ... the second consolidation is 5 to 8 weeks after the first consolidation. So, what that tells you is that the blood counts are slower to recover, and during that timeframe you want to make sure that the patient's coming in to be monitored and transfused, and that we're going over their medication lists to make sure they're not taking medications that interfere with platelet function…

….or masking fevers.

It's given as a constant intravenous infusion over 90 minutes through an infusion pump. It has to be a central venous catheter, or we use a lot of PICCs -- peripherally inserted central catheters. You don't use an inline filter, and you do want to flush the line after administration with normal saline or 5% dextrose. And of course, like with other chemotherapies, you don't want to mix anything else through that line -- no other drugs go in through it.

This is looking at dosing considerations for hepatic and renal impairment for bilirubin 3 or less.

The pharmacokinetics of total cytarabine and daunorubicin were not altered with a bilirubin greater than 3; the pharmacokinetics are unknown.

And with renal impairment mild or moderate, not clinically significantly altered. So, you can see the creatinine clearance there of 30 mL per minute to 89. And then severe end-stage…

…renal disease, the potential effects on the pharmacokinetics are unknown.

((Voice Over))
Serious or fatal hemorrhage including CNS hemorrhage have occurred with VYXEOS. Monitor blood counts regularly and provide platelet transfusions as needed.

Due to the risk of cardiotoxicity, VYXEOS is not recommended in patients with impaired cardiac function. Discontinue in patients with impaired cardiac function unless the benefit of treatment outweighs the risk. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS.

Discontinue in patients with severe or life-threatening hypersensitivity reactions, treat the signs and symptoms and monitor until resolution.

Use only if the benefit outweighs the risks in patients with Wilson’s disease or other copper-related metabolic disorders. Discontinue in patients who develop acute copper toxicity.

Administer by the intravenous route only.

Advise females and males of the potential for VYXEOS to cause fetal harm and to use effective contraception.

The most common adverse reactions include hemorrhagic events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting.

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg 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).

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg 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).

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.