Daunorubicin Liposomal; Cytarabine Liposomal injection

What is this medicine?

DAUNORUBICIN LIPOSOMAL; CYTARABINE LIPOSOMAL (daw noe ROO bi sin LIP oh som al; sye TARE a been LIP oh som al) is a chemotherapy drug. It is used to treat acute myelogenous leukemia.

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• chest pain or palpitations

• fast, irregular heartbeat

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• mouth sores

• pain, redness, or irritation at site where injected

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of worsening heart failure like breathing problems; swelling in your legs and feet

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• loss of appetite

• nausea, vomiting

• tiredness

• trouble sleeping

What may interact with this medicine?

This medicine may interact with the following medications:

• other drugs that may cause cardiac toxicity

• other drugs that may cause liver toxicity

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease

• kidney disease

• liver disease

• recent or ongoing radiation therapy

• Wilson's disease or other copper-related metabolic disorders

• an unusual or allergic reaction to daunorubicin, cytarabine, other chemotherapy agents, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You may need blood work done while you are taking this medicine.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Do not become pregnant while taking this medicine or for at least 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 6 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 2 weeks after stopping it.

In males, this medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.