daunorubicin 44 mg and cytarabine 100 mg in liposome IV solution

Generic name:
Daunorubicin/cytarabine liposome - injection

Pronunciation
(DAW-noe-ROO-bi-sin/sye-TAR-abeen)

Brand name(s)
Vyxeos

This medication is not given the same way as similar products including daunorubicin, daunorubicin liposome, cytarabine, or cytarabine liposome. Do not use any of these similar products while using daunorubicin/cytarabine liposome injection.

This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This effect may occur during treatment or months to years after treatment is completed. The risk of heart problems is increased if you have heart disease, or have had radiation treatment to the chest area, or use/have used drugs that can also cause heart problems. Tell your doctor right away if you notice symptoms such as irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.

This medication must be given only by injection into a vein. It must not be given by injection into a muscle or under the skin. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.

This medication is a combination product of daunorubicin and cytarabine liposome and is used to treat leukemia. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

This medication is given by injection into a vein as directed by your doctor. It is given by a health care professional, usually over 90 minutes. The dosage and treatment schedule are based on your medical condition, body size, and response to treatment.

Drink plenty of fluids while using this medication unless otherwise directed by your doctor. Doing so helps decrease the risk of certain side effects (such as increased uric acid).

See also Warning section.

Nausea, vomiting, constipation, diarrhea, and loss of appetite may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. Brush your teeth carefully/gently, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• unusual bleeding/bruising (such as small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• trouble breathing
• severe dizziness

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using this product, tell your doctor or pharmacist if you are allergic to daunorubicin, daunorubicin liposome, cytarabine, or cytarabine liposome; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood/bleeding problems (such as anemia)
• gout
• heart problems (such as heart failure, irregular heartbeat)
• kidney disease
• liver disease
• radiation treatment (especially to the chest area)
• Wilson's disease

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using this medication before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication contains copper. Caution is advised if you have any condition (such as Wilson's disease) that requires you to limit/avoid copper. Talk to your doctor for details.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this drug, especially heart problems.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using this medication. Daunorubicin/cytarabine liposome may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as kidney/liver function, complete blood count, uric acid, EKG) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.