Cytarabine and daunorubicin liposomal is a combination medicine used to treat acute myeloid leukemia that is newly diagnosed in adults and children at least 1 year old.

Cytarabine and daunorubicin liposomal may also be used for purposes not listed in this medication guide.

You should not be treated with this medicine if you are allergic to cytarabine or daunorubicin.

Tell your doctor if you have ever had:

• heart disease;
• liver or kidney disease;
• radiation treatment of your chest area; or
• Wilson's disease (a rare genetic disorder).

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Cytarabine and daunorubicin liposomal can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 6 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using this medicine.

It may be harder for you to get a woman pregnant while you are using this medicine. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose.

Use Cytarabine And Daunorubicin (Liposomal)(Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cytarabine and daunorubicin liposomal can make it easier for you to bleed. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, rectum), or any bleeding that will not stop;
• signs of bleeding in your digestive tract--feeling very weak or dizzy, severe stomach pain, black or bloody stools, coughing up blood or vomit that looks like coffee grounds; or
• signs of bleeding in the brain--sudden numbness or weakness (especially on one side of the body), sudden severe headache, problems with vision or balance.

Call your doctor at once if you have:

• severe or ongoing diarrhea;
• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
• fast, slow, or uneven heart rate;
• pain, burning, irritation, or skin changes where the injection was given;
• heart problems--swelling, rapid weight gain, feeling short of breath; or
• signs of infection--fever, chills, swollen gums, skin sores, cold or flu symptoms, cough with mucus, chest pain, wheezing, trouble breathing, rapid heart rate, fainting.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• bleeding (especially nosebleeds);
• fever, chills;
• irregular heartbeats;
• nausea, vomiting, stomach pain, loss of appetite;
• diarrhea, constipation;
• mouth sores;
• cough, trouble breathing;
• rash;
• muscle or joint pain;
• headache, feeling tired;
• swelling anywhere in your body; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.