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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.

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of daunorubicin and cytarabine injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

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.

Interactions with 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
• Varicella Virus Vaccine

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
• Cholera Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Trastuzumab
• Typhoid Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

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.

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.

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. 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 shortness of breath, chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, 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 a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires 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.

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:

• Bleeding gums
• blood in the urine or stools
• blurred vision
• body aches or pain
• chest pain or discomfort
• 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
• nasal congestion
• 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 nose
• scaling
• seeing, hearing, or feeling things that are not there
• skin rash
• sneezing
• sore throat
• stomach cramps
• stomach pain
• sweating
• swelling
• swelling of the face, fingers, feet, or lower legs
• tenderness
• thickening of the bronchial secretions
• tightness in the chest
• troubled breathing
• troubled breathing with exertion
• 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:

• 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.