In the U.S.—

In Canada—

• Antineoplastic

Liposomal doxorubicin (LIP-oh-som-al dox-oh-ROO-bi-sin) belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancer.

Liposomal doxorubicin seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by liposomal 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 for months or years after the medicine is used.

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

Liposomal doxorubicin is to be administered only by or under the immediate 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 liposomal doxorubicin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to liposomal doxorubicin. Also tell your health care professional if you are allergic to any other substances, such as preservatives.

Pregnancy—This medicine may cause birth defects if either the male or the female parent is receiving it at the time of conception or if it is taken by the mother during pregnancy. In addition, many cancer medicines may cause sterility, which may be permanent. Although sterility has been reported only in male dogs treated with the active ingredient of this medicine, the possibility of an effect in human males should be kept in mind.

Be sure that you have discussed this with your doctor before receiving this medicine. It is best to use some kind of birth control while you are receiving liposomal doxorubicin. Tell your doctor right away if you think you have become pregnant while receiving liposomal doxorubicin.

Breast-feeding—Because liposomal doxorubicin may cause serious side effects in a nursing baby, breast-feeding is generally not recommended while you are receiving it.

Children—There is no specific information comparing the use of liposomal doxorubicin in children with use in any other age group. Safety and efficacy of liposomal doxorubicin in children have not been established. However, problems are more likely to occur in children younger than 2 years of age, who are usually more sensitive to the effects of the active ingredient, doxorubicin.

Older adults— This medicine has been tested in a limited number of patients 60 years of age or older and has not been shown to cause different side effects in older people than it does in younger adults. However, problems are more likely to occur in the elderly, who are usually more sensitive to the effects of the active ingredient, doxorubicin. The elderly are also 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 you are taking liposomal 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—Liposomal doxorubicin may increase the effects of these medicines or radiation therapy on the blood

• Daunorubicin (e.g., Cerubidine) or
• Doxorubicin (e.g., Adriamycin) or
• Idarubicin (e.g., Idamycin) or
• Mitoxantrone (e.g., Novantrone)—Concurrent use of maximum cumulative doses of other anthracyclines with liposomal doxorubicin may increase risk of heart damage or blood problems. Concurrent use may increase risk of liver problems.

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

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

• Infection—Liposomal doxorubicin can decrease your body's ability to fight infection

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

Liposomal doxorubicin is sometimes given together with certain other medicines. If you are using 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 receiving liposomal doxorubicin, 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.

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

Dosing—

The dose of liposomal 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 size, and whether or not other medicines are also being taken. If you are receiving liposomal doxorubicin at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of liposomal 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 liposomal doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Liposomal 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 poliovirus vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. 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 the mouth.

Liposomal 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.
• 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 can occur.

If liposomal 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.

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.

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.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common–in any treatment group
  • Black, tarry stools;  blood in urine or stools;  chills;  cough or hoarseness;  facial swelling;  fever ;  headache;  loss of strength and energy;  low blood pressure;  lower back or side pain;  painful or difficult urination;  pinpoint red spots on skin;  shortness of breath;  sore throat;  sores in mouth and on lips;  unusual bleeding or bruising;  unusual tiredness or weakness  
  
  

• Less common–in any treatment group
  • Skin rash or itching 
  
  

• Rare–in any treatment group
  • Yellowing of the eyes and skin 
  
  

• Less common—for patients being treated for Kaposi's sarcoma
  • Cough;  darkening or redness of skin ;  fast or irregular heartbeat;  fever;  pain at place of injection ;  reddening of skin;  scaling of skin on hands and feet;  shortness of breath;  swelling of the feet and lower legs;  swelling of skin;  troubled breathing;  ulceration of skin;  wheezing 
  
  

• Rare—for patients being treated for Kaposi's sarcoma
  • Blurred or loss of vision;  eye pain ;  flushed, dry skin;  frequent urination;  fruit-like breath odor;  unusual thirst 
  
  

• More common—for patients being treated for ovarian cancer
  • Reddening of skin;  scaling of skin on hands and feet;  swelling of skin;  ulceration of skin 
  
  

• Less common—for patients being treated for ovarian cancer
  • Chest pain;  decreased urination;  rapid weight gain;  bloating or swelling of face, hands, lower legs, and/or feet;  fever or chills;  cough or hoarseness;  lower back or side pain;  painful or difficult urination  
  
  

• Rare—for patients being treated for ovarian cancer
  • Cough;  difficulty swallowing;  fast or irregular heartbeat;  hives;  pain at place of injection ;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue;  shortness of breath;  swelling of the feet and lower legs;  tightness in chest;  wheezing 
  
  

• Symptoms of overdose
  • Black, tarry stools;  blood in urine or stools;  cough or hoarseness accompanied by fever or chills;  fever or chills;  lower back or side pain accompanied by fever or chills;  painful or difficult urination accompanied by fever or chills;  pinpoint red spots on skin;  sores in mouth and on lips;  unusual bleeding or bruising 
  
  

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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common–in any treatment group
  • Diarrhea;  nausea;  vomiting 
  
  

• Less common–in any treatment group
  • Back pain;  difficulty swallowing;  dizziness 
  
  

• More common—for patients being treated for Kaposi's sarcoma
  • Creamy white, curd-like patches in mouth or throat;  pain when eating or swallowing 
  
  

• Less common—for patients being treated for Kaposi's sarcoma
  • Constipation;  headache 
  
  

• More common—for patients being treated for ovarian cancer
  • Abdominal or stomach pain;  loss of appetite ;  changes in the lining of the mouth or nose;  constipation;  headache;  pain;  rash;  sore throat;  tingling, burning, or prickly sensations  
  
  

• Less common—for patients being treated for ovarian cancer
  • Anxiety;  bad, unusual, or unpleasant (after)taste;  burning, dry, or itching eyes;  difficulty swallowing;  change in taste ;  excessive tearing;  itching skin;  muscle aches;  redness, pain, swelling of eye, eyelid, or inner lining of eyelid;  trouble sleeping 
  
  

• Rare—for patients being treated for ovarian cancer
  • Shakiness and unsteady walk;  clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination ;  change in sense of smell;  chills;  cough;  fever;  general feeling of discomfort or illness;  increased white vaginal discharge;  joint pain;  nausea;  shivering;  sore throat;  sweating;  thinking abnormal;  vomiting 
  
  

Liposomal 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.

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—for patients being treated for ovarian cancer
  • Dry skin 
  
  

• Less common—for patients being treated for ovarian cancer
  • Change in skin color 
  
  

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

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. 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 doctor.

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, liposomal doxorubicin is used in certain patients with the following medical conditions:

• Cancer of the breast

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