Doxorubicin Lipid Complex Injection

IMPORTANT WARNING:

Doxorubicin 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 doxorubicin 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 cyclophosphamide (Cytoxan), daunorubicin (Cerubidine, DaunoXome), epirubicin (Ellence), idarubicin (Idamycin), mitoxantrone (Novantrone), paclitaxel (Abraxane, Onxol), trastuzumab (Herceptin), or verapamil (Calan, Isoptin). 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.

You may experience a serious allergic reaction while you receive a dose of doxorubicin lipid complex injection. Tell your doctor or nurse immediately if you experience any of these symptoms while you receive doxorubicin lipid complex: hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; flushing; fever; chills; back pain; headache; difficulty breathing or swallowing; shortness of breath; or chest tightness.

Doxorubicin can cause a severe decrease in the number of blood cells in your bone marrow. Your doctor will order laboratory tests regularly before and during your treatment. A decrease in the number of blood cells in your body may cause certain symptoms and may increase the risk that you will develop a serious infection or bleeding. Tell your doctor and pharmacist if you are taking or have received azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), or progesterone (Provera, Depo-Provera). If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.

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

WHY is this medicine prescribed?

Doxorubicin lipid complex is used to treat ovarian cancer that has not improved or that has worsened after treatment with other medications. Doxorubicin lipid complex is also used to treat 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) that has not improved or that has worsened after treatment with other medications. Doxorubicin lipid complex is also in combination with another chemotherapy drug to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved or that has worsened after treatment with other medications. Doxorubicin lipid complex is in a class of medications called anthracyclines. It works by slowing or stopping 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?

Doxorubicin 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. When doxorubicin lipid complex is used to treat ovarian cancer, it is given once every 4 weeks. When doxorubicin lipid complex is used to treat Kaposi's sarcoma, it is given once every 3 weeks. When doxorubicin lipid complex is used to treat multiple myeloma, it is given on certain days every 3 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 doxorubicin lipid complex,

• tell your doctor and pharmacist if you are allergic to doxorubicin, any other medications, or any of the ingredients in doxorubicin lipid complex 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: certain chemotherapy medications such as cytarabine (DepoCyt), dexrazoxane (Zinecard), mercaptopurine (Purinethol), streptozocin (Zanosar); phenobarbital (Luminal Sodium); or phenytoin (Dilantin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Other medications may also interact with doxorubicin lipid complex, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant or breast-feed while you are receiving doxorubicin lipid complex. If you become pregnant while receiving doxorubicin lipid complex, call your doctor. Doxorubicin 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?

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

• loss of appetite (or weight loss)
• nausea
• vomiting
• stomach pain
• diarrhea
• constipation
• unusual tiredness or weakness
• dizziness
• hair loss
• nosebleed
• red or orange discoloration of urine

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:

• sores in the mouth and throat
• tingling, burning, redness, swelling, peeling or flaking, blisters, or sores on the palms of the hands or soles of the feet
• pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected

Doxorubicin 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:

• sores in the mouth and throat
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit
• vomited material that looks like coffee grounds

What OTHER INFORMATION should I know?

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

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.