Pronunciation:

daw-noe-ROO-bi-sin LYE-poh-some, sye-TARE-a-been LYE-poh-some

Brand Names:

• Vyxeos

Dosage Forms:

• Powder for Solution

Warnings:

Do not interchange with other DAUNOrubicin- and/or cytarabine-containing productsDAUNOrubicin and cytarabine, liposome 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 .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antimetabolite

Chemical—

Anthracycline

Uses of This Medicine:

Daunorubicin and cytarabine injection is used to treat therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (AML-MRC).

Daunorubicin and cytarabine liposome interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected by doxorubicin and cytarabine liposome, other unwanted side effects will also occur. Some of these may be serious and must be reported to your doctor.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of daunorubicin and cytarabine injection in children 1 year of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of daunorubicin and cytarabine injection in the elderly. However, elderly patients are more likely to have bleeding problems, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Tasonermin
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cedazuridine
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Margetuximab
• Pertuzumab
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Trastuzumab
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Heart disease or
• Kidney disease or
• Liver disease or
• Wilson's disease (high levels of copper in the body)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for over 90 minutes.

You may receive other medicines to help prevent vomiting before starting treatment with this medicine.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood, heart, kidney, and liver tests are needed to check for unwanted effects before starting each cycle of treatment with this medicine.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 months after the last dose of this medicine. Men should use an effective form of birth control during treatment and for at least 6 months after the last dose to prevent pregnancy in a sexual partner. If a pregnancy occurs while using the medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal. These may be signs of bleeding problems.

If you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, excessive swelling of the hands, wrist, ankles, or feet, or trouble breathing, check with your doctor right away. These may be symptoms of a heart problem or your body keeping too much water.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine contains copper gluconate. Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, yellow eyes or skin, changes in mood, blurred or double vision, difficulty in walking, headache, numbness or tingling in your fingers and toes, or trouble sleeping. These could be symptoms of copper toxicity.

This medicine may cause tissue damage at the injection site where this medicine has leaked. Talk to your doctor if you have any concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Bleeding gums

blood in the urine or stools

blurred vision

body aches or pain

chest pain, discomfort, or tightness

chills

confusion as to time, place, or person

cough

coughing up blood

deafness

decreased frequency or amount of urine

diarrhea

difficulty in breathing or swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear congestion

facial swelling

fainting

fast, slow, or irregular heartbeat

fever

general feeling of discomfort or illness

headache

holding false beliefs that cannot be changed by fact

increased blood pressure

increased menstrual flow or vaginal bleeding

increased thirst

itching of the genitals or other skin areas

loss of appetite

loss of voice

lower back or side pain

nausea

nervousness

nosebleeds

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

pounding in the ears

prolonged bleeding from cuts

rapid, shallow breathing

red or black, tarry stools

red or dark brown urine

runny or stuffy nose

scaling

seeing, hearing, or feeling things that are not there

skin rash

sneezing

sore throat

stomach cramps or pain

sweating

swelling

swelling of the face, fingers, feet, or lower legs

tenderness

thickening of the bronchial secretions

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

vomiting

watery or bloody diarrhea

weakness

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Anxiety

belching

bleeding after having a bowel movement

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

bone and muscle pain

burning, dry, or itching of the eyes

changes in vision

constipation

cracked lips

decreased appetite

discharge, excessive tearing

heartburn

indigestion

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

small red or purple spots on the skin

stomach discomfort or upset

trouble sleeping

uncomfortable swelling around the anus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.