Daunorubicin hydrochloride and cytarabine liposome

What is Daunorubicin hydrochloride and cytarabine liposome?

• Daunorubicin hydrochloride and cytarabine liposome (Vyxeos) is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor used to treat certain types of newly diagnosed acute myeloid leukemia (AML).

Daunorubicin

Daunorubicin ball-and-stick

Cytarabine active

Cytarabine ball-and-stick

What are the uses of this medicine?

• Daunorubicin hydrochloride and cytarabine liposome (Vyxeos) is used 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.

How does this medicine work?

• Vyxeos (daunorubicin and cytarabine) liposome for injection is a liposomal formulation of daunorubicin and cytarabine at a fixed 1:5 molar ratio.
• It may have fewer side effects and work better than other forms of daunorubicin hydrochloride and cytarabine.

Daunorubicin:

• Daunorubicin is a parenterally administered, cytotoxic antibiotic which is believed to act by intercalating between DNA base pairs and uncoiling the DNA helix, which results in inhibition of DNA synthesis and apoptosis of rapidly dividing cells.

Cytarabine:

• Cytarabine is a pyrimidine analog and is also known as arabinosylcytosine (ARA-C).
• It is converted into the triphosphate form within the cell and competes with cytidine to incorporate itself in the DNA.
• The sugar moiety of cytarabine hinders the rotation of the molecule within the DNA.
• The DNA replication ceases, specifically during the S phase of the cell cycle, making it a specific drug for rapidly dividing cells, such as those seen in cancer.
• DNA replication and repair also halts due to the inhibition of DNA polymerase by cytarabine.
• This drug must act for a time equivalent to one cell cycle to effectively inhibit the replication of tumor cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• history of serious hypersensitivity reaction to cytarabine, daunorubicin, or any component

What drug interactions can this medicine cause?

• Concomitant use of cardiotoxic agents may increase the risk of cardiotoxicity.
• Concomitant use with hepatotoxic agents may impair liver function and increase the toxicity of Vyxeos.

Is this medicine FDA approved?

• Vyxeos was approved for use in the United States in 2017.

How should this medicine be used?

Recommended dosage:

• Induction: Vyxeos (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5 and on days 1 and 3 for subsequent cycles of induction, if needed.
• Consolidation: Vyxeos (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome via intravenous infusion over 90 minutes on days 1 and 3.

Administration:

• Daunorubicin and cytarabine lipid complex comes as a powder to be mixed with liquid and injected intravenously (into a vein) by a doctor or nurse in a medical facility.
• It is usually injected over 90 minutes once a day on certain days of your treatment period.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 44 mg daunorubicin and 100 mg cytarabine encapsulated in liposomes as a lyophilized cake in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Vyxeos

What side effects can this medication cause?

The most common side effects of this medicine 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
• vomiting

What special precautions should I follow?

• Serious or fatal hemorrhagic events with associated prolonged thrombocytopenia have occurred with Vyxeos. Monitor blood counts regularly until recovery.
• Vyxeos contains the anthracycline daunorubicin, which has a known risk of cardiotoxicity. Vyxeos treatment is not recommended in patients with cardiac function that is less than normal. Discontinue Vyxeos in patients with impaired cardiac function unless the benefit of continuing treatment outweighs the risk.
• Serious or fatal hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. If severe or life-threatening hypersensitivity reaction occurs, discontinue Vyxeos, treat according to standard of care, and monitor until signs and symptoms resolve.
• Daunorubicin has been associated with local tissue necrosis at the site of drug extravasation. Confirm intravenous access before administration. Administer Vyxeos by the intravenous route only.
• Vyxeos Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Reconstituted Vyxeos contains 5 mg/mL copper gluconate, of which 14% is elemental copper. There is no clinical experience with Vyxeos in patients with Wilson’s disease or other copper-related metabolic disorders.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Vyxeos can cause embryo-fetal harm when administered to a pregnant woman.
• There are no adequate and well-controlled studies of Vyxeos, daunorubicin, or cytarabine in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Vyxeos have been established in pediatric patients 1 year and older with newly diagnosed t AML or AML-MRC.
• The safety and effectiveness of Vyxeos in pediatric patients less than 1 year of age with newly-diagnosed t-AML or AML-MRC have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CYTARABINE
• DAUNORUBICIN

Inactive ingredients:

• DISTEAROYLPHOSPHATIDYLCHOLINE,
• DISTEAROYLPHOSPHATIDYLGLYCEROL,
• CHOLESTEROL
• COPPER GLUCONATE
• TROLAMINE
• SUCROSE

Who manufactures and distributes this medicine?

Distributed by:

• Jazz Pharmaceuticals, Inc.
• Palo Alto, CA

• Vyxeos® is a trademark of Jazz Pharmaceuticals plc or its subsidiaries.

What should I know about storage and disposal of this medication?

Storage:

• Store unreconstituted Vyxeos vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in an upright position.
• The vial should be stored in its original carton to protect from light.

Handling and Disposal:

• Vyxeos is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Daunorubicin hydrochloride and cytarabine liposome
• FDA Daunorubicin hydrochloride and cytarabine liposome

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Daunorubicin hydrochloride and cytarabine liposome Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski