(daw'' noe roo' bi sin) (sye tare' a been)

Brand Name(s): Vyxeos^®

IMPORTANT WARNING:

Daunorubicin and cytarabine lipid complex is different than other products containing these medications and should not be substituted for one another.

WHY is this medicine prescribed?

Daunorubicin and cytarabine lipid complex is used to treat certain types of acute myeloid leukemia (AML; a type of cancer of the white blood cells) in adults and children 1 year of age and older. Daunorubicin is in a class of medications called anthracyclines. Cytarabine is in a class of medications called antimetabolites. Daunorubicin and cytarabine lipid complex slows or stops the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

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.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving daunorubicin and cytarabine lipid complex,

• tell your doctor and pharmacist if you are allergic to daunorubicin, cytarabine, any other medications, or any of the ingredients in daunorubicin and cytarabine lipid complex. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol, others), cholesterol-lowering medications (statins), iron products, isoniazid (INH, Laniazid, in Rifamate, in Rifater), methotrexate (Otrexup, Rasuvo, Trexall), niacin (nicotinic acid), or rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), Also tell your doctor if are taking or have ever received certain cancer chemotherapy medications such as doxorubicin (Doxil), epirubicin (Ellence), idarubicin (Idamycin), mitoxantrone, or trastuzumab (Herceptin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with daunorubicin and cytarabine lipid complex, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have previously received radiation therapy to the chest area or have or have ever had heart disease, a heart attack, or Wilson's disease (a disease that causes copper to accumulate in the body); or if you have an infection, blood-clotting problems, or anemia (decreased amount of red blood cells in the blood).

• you should know that this medication may cause infertility in men; however, you should not assume that you cannot get someone else pregnant. Tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving daunorubicin and cytarabine lipid complex. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with daunorubicin and cytarabine lipid complex and for 6 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving daunorubicin and cytarabine lipid complex, call your doctor. Daunorubicin and cytarabine lipid complex may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with daunorubicin and cytarabine lipid complex and for at least 2 weeks after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Daunorubicin and cytarabine lipid complex may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• sores in the mouth and throat
• constipation
• diarrhea
• constipation
• stomach pain
• tiredness
• muscle or joint pain
• headache
• dizziness or lightheadedness
• unusual dreams or sleep problems, including trouble falling or staying asleep
• vision problems

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected
• rash
• hives
• itching
• shortness of breath
• difficulty breathing or swallowing
• swelling of the hands, feet, ankles or lower legs
• fast, irregular, or pounding heartbeat
• chest pain
• fever, chills, sore throat, cough, frequent or painful urination, or other signs of infection
• excessive tiredness or weakness
• unusual bleeding or bruising
• nosebleed
• black and tarry stools
• red blood in stools
• bloody vomit
• vomited material that looks like coffee grounds
• yellowing of the skin or eyes
• dark brown or yellow ring around the iris of the eye

Daunorubicin and cytarabine lipid complex may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to daunorubicin and cytarabine lipid complex.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: May 15, 2021.