Daunorubicin Lipid Complex Injection

IMPORTANT WARNING:

Daunorubicin lipid complex injection must be given under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Daunorubicin lipid complex may cause serious or life-threatening heart problems at any time during your treatment or months to years after your treatment has ended. Your doctor will order tests before and during your treatment to see if your heart is working well enough for you to safely receive daunorubicin lipid complex. These tests may include an electrocardiogram (ECG; test that records the electrical activity of the heart) and an echocardiogram (test that uses sound waves to measure your heart's ability to pump blood). Your doctor may tell you that you should not receive this medication if the tests show your heart's ability to pump blood has decreased. Tell your doctor if you have or have ever had any type of heart disease or radiation (x-ray) therapy to the chest area. Tell your doctor and pharmacist if you are taking or have ever received certain cancer chemotherapy medications such as doxorubicin (Doxil), epirubicin (Ellence), idarubicin (Idamycin), mitoxantrone (Novantrone), cyclophosphamide (Cytoxan), or trastuzumab (Herceptin). If you experience any of the following symptoms, call your doctor immediately: shortness of breath; difficulty breathing; swelling of the hands, feet, ankles or lower legs; or fast, irregular, or pounding heartbeat.

Daunorubicin lipid complex can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious infection. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection.

Tell your doctor if you have or have ever had liver disease. Your doctor may need to adjust your dose if you have liver disease.

You may experience a reaction while you receive a dose of daunorubicin lipid complex injection, usually within 5 minutes after your infusion starts. Tell your doctor immediately if you experience any of these symptoms while you receive daunorubicin lipid complex: back pain, flushing, and chest tightness.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to daunorubicin lipid complex.

WHY is this medicine prescribed?

Daunorubicin lipid complex is used to treat advanced Kaposi's sarcoma (a type of cancer that causes abnormal tissue to grow on different parts of the body) related to acquired immunodeficiency syndrome (AIDS). Daunorubicin lipid complex is in a class of medications called anthracyclines. It slows or stops the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Daunorubicin lipid complex comes as a liquid to be injected intravenously (into a vein) over 1 hour by a doctor or nurse in a medical facility. It is usually given once every 2 weeks.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving daunorubicin lipid complex,

• tell your doctor and pharmacist if you are allergic to daunorubicin, any other medications, or any of the ingredients in daunorubicin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex, Trexall), sirolimus (Rapamune), and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving daunorubicin lipid complex. If you become pregnant while receiving daunorubicin lipid complex, call your doctor. Daunorubicin lipid complex may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Daunorubicin lipid complex may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• sores in the mouth and throat
• diarrhea
• stomach pain
• constipation
• hair loss

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• redness, pain, swelling, or burning at the site where the injection was given
• rash
• hives
• itching

Daunorubicin lipid complex may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• extreme tiredness
• fever, sore throat, ongoing cough and congestion, or other signs of infection

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.