National Comprehensive Cancer Network® adds Jazz Pharmaceuticals' Vyxeos™ (daunorubicin and cytarabine) Liposome for Injection to Clinical Practice Guidelines in Oncology
"We appreciate the decision by the NCCN to incorporate Vyxeos into the Clinical Practice Guidelines in Oncology as it supports our commitment to ensuring that patients, through their health care professionals, are able to access this important new treatment option," said
The NCCN, a not-for-profit alliance of 27 leading U.S. cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care—including physicians, nurses, pharmacists, payers, patients and their families—with the ultimate goal of improving patient care and outcomes.
Vyxeos™ (daunorubicin and cytarabine) liposome for injection 44mg/100mg is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion.1 Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC. For more information about Vyxeos in
Important Safety Information
Vyxeos has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute Vyxeos for other daunorubicin- and/or cytarabine- containing products.
Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine or any of its ingredients.
Vyxeos can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with Vyxeos. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.
Vyxeos can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:
- shortness of breath or trouble breathing
- swelling or fluid retention, especially in the feet, ankles or legs
- unusual tiredness
Vyxeos may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:
- trouble breathing
- severe itching
- skin rash or hives
- swelling of the face, lips, mouth, or tongue
Vyxeos contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders.
Vyxeos can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.
Vyxeos can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving Vyxeos. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of Vyxeos.
The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.
Please see full Prescribing Information for Vyxeos before prescribing: http://pp.jazzpharma.com/pi/vyxeos.en.USPI.pdf
Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body's new blood cells.2 AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.3 AML is a relatively rare disease representing 1.3 percent of all new cancer cases.4 It is estimated that more than 21,000 people will be diagnosed with AML in
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the addition of Vyxeos to the NCCN Guidelines,
- Vyxeos [package insert].
Palo Alto, CA: Jazz Pharmaceuticals; 2017. National Cancer Institute. General Information About Adult Acute Myeloid Leukemia https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq Accessed June 7, 2017. American Cancer Society. What is Acute Myeloid Leukemia? https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html Accessed March 20, 2017.
- SEER Stat Facts: AML. 2017.
American Cancer Society. Key Statistics About Acute Myeloid Leukemia. https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html Accessed March 20, 2017.
- Baer MR, et al., Leukemia, 2011 May; 25(5):10.1038/eu.2011.9.
- Klepin HD. Hematology Am Soc Hematol Educ Program. 2014;2014(1):8-13.
- Goldstone AH, Burnett AK, Avivi I et al. Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age. AML 10, 11, 12 MRC Trials. Blood 2002; 100 (88a): (Abstr 322).
- Schiller GJ, Hematol Educ Program, 2013:201-208.
- Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype. J Clin Oncol. 2004 Jun 15;22(12):2510-1.
- Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6): 857–859. doi: 10.3324/haematol.2010.023184.
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