Doxorubicin should be administered only into a vein. However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, blisters, or sores in the place where the medication was injected.

Doxorubicin 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. 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 you have an abnormal heart rate or 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, a heart attack, 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.

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.

Doxorubicin may increase your risk for developing leukemia (cancer of the white blood cells), especially when it is given in high doses or together with certain other chemotherapy medications and radiation (x-ray) therapy.

Tell your doctor if you have or have ever had liver disease. Your doctor may tell you that you should not receive this medication or may change your dose if you have liver disease.

Doxorubicin should be given only under the supervision of a doctor with experience in the use of chemotherapy medications.

Doxorubicin is used in combination with other medications to treat certain types of bladder, breast, lung, stomach, and ovarian cancer; Hodgkin’s lymphoma (Hodgkin’s disease) and non-Hodgkin’s lymphoma (cancer that begins in the cells of the immune system); and certain types of leukemia (cancer of the white blood cells), including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML, ANLL). Doxorubicin is also used alone and in combination with other medications to treat certain types of thyroid cancer and certain types of soft tissue or bone sarcomas (cancer that forms in muscles and bones). It is also used to treat neuroblastoma (a cancer that begins in nerve cells and occurs mainly in children) and Wilms’ tumor (a type of kidney cancer that occurs in children). Doxorubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.

Doxorubicin comes as a solution (liquid) or as a powder to be mixed with liquid to be injected intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given once every 21 to 28 days. The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer you have.

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

Doxorubicin is also sometimes used to treat cancer of the uterus, endometrium (lining of the uterus), and cervix (opening of the uterus); prostate cancer (cancer of a male reproductive organ); pancreatic cancer; adrenocortical cancer (cancer in the adrenal glands); liver cancer; Kaposi’s sarcoma related to acquired immunodeficiency syndrome (AIDS); Ewing’s sarcoma (a type of bone cancer) in children; mesothelioma (cancer in the lining of the chest or abdomen); multiple myeloma (a type of cancer of the bone marrow); and chronic lymphoblastic leukemia (CLL; a type of cancer of the white blood cells). Talk to your doctor about the risks of using this medication for your condition.

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

Before receiving doxorubicin injection,

• tell your doctor and pharmacist if you are allergic to doxorubicin, daunorubicin (Cerubidine, DaunoXome), epirubicin (Ellence), idarubicin (Idamycin), any other medications, or any of the ingredients in doxorubicin 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, 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.
• you should know that doxorubicin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin receiving this drug. You should not become pregnant or breast-feed while you are receiving doxorubicin injection. If you become pregnant while receiving doxorubicin, call your doctor. Use a reliable method of birth control to prevent pregnancy. Doxorubicin may harm the fetus.
• do not have any vaccinations without talking to your doctor.

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

Doxorubicin 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
• loss of appetite (and weight loss)
• weight gain
• stomach pain
• diarrhea
• increased thirst
• unusual tiredness or weakness
• dizziness
• hair loss
• separation of fingernail or toenail from the nail bed
• itchy, red, watery, or irritated eyes
• eye pain
• pain, burning, or tingling in the hands or feet
• red discoloration of urine (for 1 to 2 days after dose)

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:

• hives
• skin rash
• itching
• difficulty breathing or swallowing
• seizures

Doxorubicin 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).

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

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

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.

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• Hydroxydaunomycin Hydrochloride
• Hydroxydoxorubicin Hydrochloride