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Treatment Name: Daunorubicin and cytarabine liposome (Vyxeos®)

Daunorubicin and cytarabine liposome (Vyxeos®) is a Chemotherapy Regimen for Acute Myeloid Leukemia (AML)

How does daunorubicin and cytarabine liposome (Vyxeos®) work?
Daunorubicin and cytarabine are both designed to rapidly kill cancer cells in the blood stream and bone marrow.

Vyxeos® is a combination of daunorubicin and cytarabine inside a sphere-shaped object called a liposome. The liposomes enter the bone marrow and are "taken up" by leukemia cells bone marrow cells. When the liposome is inside the cancer cell, both daunorubicin and cytarabine are released. They damage cancer cell DNA and cause cancerous leukemia cells to die.

Daunorubicin and cytarabine liposome (Vyxeos®) can be given to patients with AML caused by past chemotherapy treatments (therapy-related AML or t-AML) or patients with AML that also have myelodysplasia (Myelodysplasia-Related Changes or AML-MRC) which arises from myelodysplastic syndrome

Goals of therapy:
Daunorubicin and cytarabine liposome (Vyxeos®) is given to eliminate leukemia cells from the body and to decrease symptoms from AML, such as bleeding, bruising and recurrent infections. It is commonly given with the goal of cure or to help patients reach remission so that a bone marrow transplant can be performed. 

Alternative names:
CPX-351

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Schedule

Daunorubicin and cytarabine liposome (Vyxeos®) commonly requires a three to four-week stay in a hospital (or sometimes longer), depending upon how well the side effects are tolerated and whether a remission is achieved. Patients are typically admitted to the hospital and receive the entire treatment cycle during their stay.

Induction therapy: 

  • Daunorubicin and cytarabine liposome (Vyxeos®) intravenous (I.V.) infusion given over 90 minutes on Days 1, 3, and 5

In some cases, the I.V. infusions (Days 1, 3 and 5) may be given in an outpatient infusion center allowing the patient to go home afterwards; however, the patient must be admitted to the hospital after the completion of all the infusions for the remainder of the induction cycle due to very low blood counts that require special care.

A bone marrow biopsy is often checked 14 to 21 days after starting treatment. Depending upon the bone marrow biopsy results, your doctor may advise to proceed onto consolidation chemotherapy with more Vyxeos® once your blood cells recover to normal levels. If leukemic cells are still seen after the first induction, your doctor may recommend a second induction course.

Second Induction therapy: 
If remission has not been achieved after the first induction cycle, a second cycle of induction chemotherapy may be recommended: 

  • Daunorubicin and cytarabine liposome (Vyxeos®) I.V. infusion over 90 minutes on Days 1 and 3

Consolidation therapy:
If remission is achieved after one or two induction therapies, the first cycle of consolidation therapy (more Vyxeos® treatment) is given approximately 5 to 8 weeks after the last induction cycle once blood counts return to normal. A second cycle of Vyxeos® consolidation may be given 5 to 8 weeks after the first consolidation treatment. Consolidation therapy can be given in an outpatient infusion center, allowing the person to go home afterwards.

  • Daunorubicin and cytarabine liposome (Vyxeos®) I.V. infusion over 90 minutes on Days 1 and 3 

Estimated total infusion time for this treatment: 

  • Up to two hours for each treatment, but sometimes longer if you experience infusion reactions
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Duration of therapy may last up to four to six months, depending upon response, tolerability, number of consolidation chemotherapy cycles prescribed, and availability of a stem cell transplant. 

Click here for the  common daunorubicin and cytarabine liposome (Vyxeos®) starting doses.

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Side Effects

In clinical studies, the most commonly reported side effects of daunorubicin and cytarabine liposome (Vyxeos®) are shown here. Side effects sometimes have percentage ranges [example: 64 – 66% neutropenic fever] because they differed between clinical studies: 

  • Neutropenic fever (64 - 66%),
  • Blood stream infection (23 - 35%),
  • Pneumonia [lung infection] (15 - 20%),
  • Low blood potassium (15%),
  • Fungal infection (7 - 14%),
  • Life threatening infection (12%),
  • Low blood oxygen (7 - 12%),
  • Shortness of breath (6 - 11%),
  • Bleeding (10%),
  • Increased blood pressure (10%),
  • Injury to the heart (9%),
  • Decreased kidney function (5 - 9%),
  • Fatigue (5 - 9%),
  • Diarrhea (3 - 9%),
  • Rash (5 - 8%),
  • Urinary tract infection [UTI] (7%),
  • Abnormal heart rhythm (7%),
  • Fainting (7%),
  • Low blood pressure (5%),
  • Confusion and other changes in mental status (3 - 5%),
  • Kidney failure (4%),
  • Muscle pain (3%),
  • Chest pain (3%),
  • Stomach pain (2%),
  • Swelling (2%),
  • Fluid in the sac around the lungs (2%),
  • Nausea and Vomiting (1%). 

*All patients during treatment experience very low red blood cells [anemia], white blood cells [neutropenia], and platelets [thrombocytopenia].

The side effects experienced by patients in the induction phase and consolidation phase were similar; however, side effects in the consolidation phase were typically experienced less often than with induction chemo.

Side effect videos Side Effect Videos
AnemiaAnemiaNeutropenic FeverNeutropenic FeverBleedingBleedingFatigue Fatigue DiarrheaDiarrheaNausea and VomitingNausea and VomitingPainPain

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, then daily or every other day for the first few weeks for induction therapy. During consolidation therapy, labs may be checked before treatment, then periodically during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), lactate dehydrogenase (LDH), phosphorous, and uric acid, plus any others your doctor may order.

If you have Wilson’s disease, you may need to have blood copper levels checked more often as Vyxeos® (daunorubicin and cytarabine liposome) contains copper.

How often is imaging needed?
Imaging may be checked if there is concern for an infection, bleeding, or blood clot. Imaging may include: X-rays, magnetic resonance imaging (MRI), or computerized tomography (CT) scans.

Echocardiograms (Echo) or multigated acquisition (MUGA) scans to check heart function are typically performed prior to starting induction therapy and prior to each consolidation therapy treatment (or more often if needed).

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue daunorubicin and cytarabine liposome (Vyxeos®) as planned, delay the next dose until the side effect goes away, or switch to an alternative therapy.

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ChemoExperts Tips

  • Infusion reaction symptoms such as fever, shaking, and chills may occur. These side effects generally go away when the infusion is stopped. It may then be restarted at a slower rate. If you experience infusion reactions, you may need to receive a dose of an antihistamine such as diphenhydramine (Benadryl®) or a corticosteroid such dexamethasone (Decadron®) to treat the infusion reaction. You may then receive these medications before all future treatments with daunorubicin and cytarabine liposome (Vyxeos®) to prevent future infusion reactions
  • Be careful not to fall as this is especially dangerous when the platelet count is low and blood clots cannot form properly; patients are at an increased bleeding risk
  • Antibiotics, antifungal agents, and antiviral medications are commonly used to treat and prevent infection. Be sure to tell your doctor if you experience discomfort anywhere as this may be a symptom of an infection
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for AML. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Daunorubicin and cytarabine liposome (Vyxeos®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Daunorubicin and cytarabine liposome (Vyxeos®). Depending upon your income, they may be able to help cover the cost of:

  • Dauno­rubicin and cytara­bine liposome

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Daunorubicin and cytarabine liposome (Vyxeos®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Daunorubicin and cytarabine liposome (Vyxeos®)

Individual Drug Label Information

Dauno­rubicin and cytara­bine liposome (Vyxeos®)

  • ​Is an intravenous (I.V.) infusion and is purple in color 
  • Serious or life-threatening bleeding due to low blood platelets can occur 
  • May affect heart function. Electrocardiograms (ECG or EKG) are performed to check heart function before starting therapy and often before each consolidation treatment 
  • Infusion reactions may occur. If you experience an infusion reaction, the I.V. drug may need to be given over a longer period of time and medications such as diphenhydramine (Benadryl®) or a dexamethasone (Decadron®) may need to be given prior to receiving treatment 
  • Daunorubicin and cytarabine liposome (Vyxeos®) contains copper. Giving to patients with Wilson’s disease has not been studied and must be used with caution 
  • May interact with other medications that may cause liver or heart toxicity 
  • May cause fetal harm. Use effective contraception during therapy and for six months after the last dose. Women should not breast feed during therapy and for two weeks after the last dose 
General side effects from daunorubicin and cytarabine liposome (Vyxeos®): 
  • Neutropenic Fever 
  • Decreased white blood cells, red blood cells and platelets 
  • Blood stream infections 
  • Pneumonia 
  • Low blood potassium 
  • Bleeding 
  • Fungal infections 
  • Diarrhea 
  • Fatigue 
  • Increased blood pressure 
  • Heart rhythm problems 
  • Decreased kidney function 
  • Rash 
  • Urinary tract infection [UTI] 
  • Fainting 
  • Shortness of breath 
  • Confusion and other changes in mental status 
  • Click on the Daunorubicin and cytarabine liposome (Vyxeos®) package insert link below for more reported side effects, possible drug interactions, and other prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1. Lancet JE, Cortes JE, Hogge DE, et al. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood 2014;123(21):3239-46.

2. Vyxeos® [package insert]. Jazz Pharmaceuticals, Inc., Palo Alto, CA; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf. Accessed August 31, 2017.

Created: August 31, 2017 Updated: September 29, 2017

What is Acute Myeloid Leukemia (AML)?

A disease of the myeloid cells found in the bone marrow. Myeloid cells are responsible for developing into mature white blood cells, red blood cells, and platelets. In AML, immature myeloid cells know as “blasts” replicate at a very fast rate. Sometimes blasts crowd out the normal cells in the bone marrow so that red blood cells or platelets are unable to develop. Common symptoms of this include fatigue, difficulty exercising, or easy bruising or bleeding.

Most cases of AML are considered “de novo” meaning that the cause is unknown. However, there are a few known risk factors for AML, such as exposure to radiation, various environmental toxins, and certain chemotherapy agents. There is no staging system for AML. Chromosomes (strands of DNA) are often analyzed to determine which mutations in the chromosomes exist. The effectiveness of the treatment may depend upon the specific chromosome mutations that are present.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

Common Starting Doses

First Induction (1 cycle):

  • Daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome I.V. infusion over 90 minutes on Days 1, 3, and 5

Second Induction (1 cycle if needed):

  • Daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome I.V. infusion over 90 minutes on Days 1 and 3

Consolidation (1 to 2 cycles):

  • Daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 liposome I.V. infusion over 90 minutes on Days 1 and 3 

Note:  Individual doses may vary based upon your Doctor's recommendation, or drug availability.