In the U.S.—

In Canada—

• Antineoplastic

Doxorubicin ( dox-oh-ROO-bi-sin) belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancers of the blood; lymph system; bladder; breast; stomach; lung; ovaries; thyroid; nerves; kidneys; bones; and soft tissues, including muscles and tendons. It may also be used to treat other kinds of cancer, as determined by your doctor.

Doxorubicin seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by doxorubicin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with doxorubicin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Doxorubicin is to be administered only by or under the supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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 doxorubicin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to doxorubicin or lincomycin.

Pregnancy—There is a chance that this medicine may cause birth defects if either the male or female is receiving it at the time of conception or if it is taken by the mother during pregnancy. Studies in rats and rabbits have shown that doxorubicin causes birth defects in the fetus and other problems (including miscarriage). In addition, many cancer medicines may cause sterility, which could be permanent. Although sterility has been reported in animals and humans with this medicine, this is less likely to occur in humans than in animals.

Be sure that you have discussed these possible effects with your doctor before receiving this medicine. Before receiving doxorubicin make sure your doctor knows if you are pregnant or if you may become pregnant. It is best to use some kind of birth control while you are receiving doxorubicin. Tell your doctor right away if you think you have become pregnant while receiving doxorubicin.

Breast-feeding—Because doxorubicin may cause serious side effects, breast-feeding is generally not recommended while you are receiving this medicine.

Children—Heart problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of doxorubicin.

Older adults—Heart problems are more likely to occur in the elderly, who are usually more sensitive to the effects of doxorubicin. The elderly may also be more likely to have blood problems.

Other 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 receiving doxorubicin it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir) or
• If you have ever been treated with radiation or cancer medicines—Doxorubicin may increase the effects of these medicines or radiation therapy on the blood
• If you have ever been treated with radiation to your chest—Risk of heart problems caused by doxorubicin may be increased

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Doxorubicin may raise the concentration of uric acid in the blood. Since these medicines are used to lower uric acid levels, they may not work as well in patients receiving doxorubicin

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout or
• Kidney stones—Doxorubicin may increase levels of uric acid in the body, which can cause gout or kidney stones

• Heart disease—Risk of heart problems caused by doxorubicin may be increased

• Liver disease—Effects of doxorubicin may be increased because of its slower removal from the body

Doxorubicin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Doxorubicin often causes nausea and vomiting. However, it is very important that you continue to receive the medication, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of doxorubicin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's body size, and whether or not other medicines are also being taken. If you are receiving doxorubicin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of doxorubicin, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Doxorubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Doxorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If doxorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Less common
  • Fast or irregular heartbeat;  pain at place of injection;  shortness of breath;  swelling of feet and lower legs 
  
  

• Rare
  • Black, tarry stools;  blood in urine ;  pinpoint red spots on skin;  unusual bleeding or bruising;  wheezing 
  
  

Check with your health care professional as soon as possible if any of the following side effects occur:

• More common
  • Sores in mouth and on lips 
  
  

• Less common
  • Cough or hoarseness accompanied by fever or chills;  darkening or redness of skin (if you recently had radiation treatment) ;  fever or chills;  joint pain;  lower back or side pain accompanied by fever or chills;  painful or difficult urination accompanied by fever or chills;  red streaks along injected vein ;  stomach pain 
  
  

• Rare
  • Skin rash or itching 
  
  

Other 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:

• More common
  • Nausea and vomiting 
  
  

• Less common
  • Darkening of soles, palms, or nails;  diarrhea 
  
  

Doxorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with doxorubicin has ended, normal hair growth should return.

After you stop receiving doxorubicin, it may still produce some side effects that need attention. During this period of time, check with your doctor or nurse immediately if you notice any of the following side effects:

• Fast or irregular heartbeat;  shortness of breath;  swelling of feet and lower legs 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, doxorubicin is used in certain patients with the following medical conditions:

• Autoimmune deficiency syndrome (AIDS)–associated Kaposi's sarcoma (a type of cancer of the skin and mucous membranes that is more common in patients with AIDS)
• Cancer of the adrenal cortex (the outside layer of the adrenal gland)
• Cancer of the cervix
• Cancer of the endometrium
• Cancer of the esophagus
• Cancers of the head and neck
• Cancer of the liver
• Cancer of the pancreas
• Cancer of the prostate
• Cancer of the thymus (a small organ found under the breast bone)
• Carcinoid tumors
• Chronic lymphocytic leukemia (a type of cancer of the blood and lymph system)
• Ewing's sarcoma (a type of cancer found in the bone)
• Gestational trophoblastic tumors (tumors in the uterus or womb)
• Hepatoblastoma (a certain type of liver cancer that occurs in children)
• Multiple myeloma (a certain type of cancer of the blood)
• Non–small cell lung cancer (a certain type of lung cancer usually associated with prior smoking, passive smoking, or radon exposure)
• Retinoblastoma (a type of eye cancer found primarily in children)
• Tumors in the ovaries

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.