When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive it if you had an allergic reaction to daunorubicin, or if you are pregnant.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• It is normal for this medicine to turn your urine red for 1 or 2 days after your treatment.
• 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.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how daunorubicin works. Tell your doctor if you are also using methotrexate or cyclophosphamide. Also tell your doctor if you have been treated with doxorubicin or daunorubicin before.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• 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.
• Tell your doctor if you are breastfeeding, or if you have any infection, gout, heart disease, liver disease, or kidney disease.
• This medicine may cause heart problems, which can occur months to years after your treatment is complete.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, fast, pounding, or uneven heartbeat
• Fever, chills, or sore throat
• Pain, redness, or swelling where the needle is placed
• Pinpoint red or purple spots on your skin
• Rapid weight gain, swelling of hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Nausea, diarrhea, vomiting, stomach pain
• Sores or white spots on your lips or tongue, or in your mouth

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088