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Transcript of Tim’s story

TIM: When I was diagnosed I was absolutely shocked. I went in for a routine physical. The doctor did some blood work for me and called me up about a week later and said there must be something wrong in the lab you've gotta come back in and do a retest.

Kathy: I had been noticing some changes in him. You know you don’t know whether it’s because we were aging or what we were doing, so then to hear the diagnosis it was like OK how did we miss, like did I miss something, was there a way I could have done something better.

Caitlin: I don’t think anything can prepare you for your Dad sitting you down and telling you that he’s sick. From the minute he told us, it was just like taking information in with a firehose….

TIM: I initially was diagnosed with MDS. I had a clinical trial that unfortunately didn’t work. My MDS was moved to AML and that’s when my doctor prescribed or suggested I move to Vyxeos.

Kathy: Tim really decided from the moment he was diagnosed that he was going to beat this…. And he wasn’t going to become the patient. He was going to take all the responsibility for what he needed to to get through it.

Caitlin: We all heard what he said and we all knew that he was going to go at this with everything he had and that I think we all decided that we were going to do everything we could to support him.

TIM: My approach to how I was going to battle the illness was to to fight it to, to work really hard and do everything I could to put myself in the best position to be successful.

TIM: It was important to me to have a routine. I walked three times a day...they had a white board in my hospital room that every morning they would come in and give me the the white count, the red count. Monitoring that everyday and watching it kept me motivated and helped me stay focused on getting well.

TIM: I was fortunate enough to only need one cycle of Vyxeos which led to remission.

TIM: The doctor said that I would have to have a transplant in order to survive my leukemia so that was the only option that I had, which motivated me even more to do my part to get to transplant.

TIM: I was very very lucky to have a number of exact matches. We set a date for the end of the year, in December, and worked towards that goal.

TIM: I think my advice for for people is to prepare yourself for this journey. It is difficult but it’s not impossible. I would tell everyone to try to get in the best shape they could in the time they have in preparing.

TIM: I would definitely set up a group that will support you - friends, family. I started a blog which was very important to me. It helped me communicate my status to important people in my life and it also gave them the opportunity to communicate with me, encouraging me so that was very important…. Having a diary or a journal is important because it keeps you true to yourself… it helps you keep fighting.

TIM: Life is definitely different than it was before I was diagnosed. And being in full remission I think I have a different perspective in life. I think every day is a gift. Enjoying people and and everyday —making the best out of everyday is very important to me now.

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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.