DOXORUBICIN,LIPOSOMAL (Systemic)

Some commonly used brand names are:

In the U.S.?

• Doxil

In Canada?

• Caelyx

Category

• Antineoplastic

Description

Liposomaldoxorubicin (LIP-oh-som-al dox-oh-ROO-bi-sin)belongs to the general group of medicines known as antineoplastics. It isused 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 mayalso 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 maynot occur for months or years after the medicine is used.

Before you begin treatment with liposomal doxorubicin, you and your doctorshould talk about the good this medicine will do as well as the risks of usingit.

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

Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For liposomal doxorubicin, the following should be considered:

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

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

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

Breast-feeding?Because liposomal doxorubicin may cause seriousside effects in a nursing baby, breast-feeding should be stopped prior tostarting liposomal doxorubicin. Talk to your doctor about how long you needto formula feed your baby after you stop taking liposomal doxorubicin.

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

Older adults?This medicine has been tested in a limited numberof patients 60 years of age or older and has not been shown to cause differentside effects in older people than it does in younger adults. However, problemsare more likely to occur in the elderly, who are usually more sensitive tothe effects of the active ingredient, doxorubicin. The elderly are also morelikely to have blood problems.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingliposomal doxorubicin, it is especially important that your health care professionalknow 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?Liposomaldoxorubicin may increase the effects of these medicines or radiation therapyon 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 cumulativedoses of other anthracyclines with liposomal doxorubicin may increase riskof heart damage or blood problems. Concurrent use may increase risk of liverproblems.

Other medical problems?The presence of other medicalproblems may affect the use of liposomal doxorubicin. Make sure you tell yourdoctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)?Risk of severe disease affecting otherparts of the body

• Heart disease?Risk of heart problems caused by liposomal doxorubicinmay be increased

• Infection?Liposomal doxorubicin can decrease your body's abilityto fight infection

• Liver disease?Effects of liposomal doxorubicin may be increasedbecause of slower removal from the body

Proper Use of This Medicine

Liposomaldoxorubicin is sometimes given together with certain other medicines. If youare using a combination of medicines, it is important that you receive eachone 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 theright times.

While you are receiving liposomal doxorubicin, your doctor may want youto drink extra fluids so that you will pass more urine. This will help preventkidney problems and keep your kidneys working well.

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

Dosing?The dose of liposomal doxorubicin will be differentfor 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 whetheror not other medicines are also being taken. If you arereceiving liposomal doxorubicin at home, follow your doctor's orders or thedirections on the label. If you have any questions about the properdose of liposomal doxorubicin, ask your doctor.

Precautions While Using This Medicine

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 forunwanted effects.

While you are being treated with liposomal doxorubicin, and after you stoptreatment with it, do not have any immunizations (vaccinations)without your doctor's approval. Liposomal doxorubicin may lower yourbody's resistance and there is a chance you might get the infection the immunizationis meant to prevent. In addition, other persons living in your household shouldnot take oral poliovirus vaccine since there is a chance they could pass thepoliovirus 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 verylong. If you cannot take these precautions, you should consider wearing aprotective face mask that covers the nose and the mouth.

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

• If you can, avoid people with infections. Checkwith your doctor immediately if you think you are getting an infectionor 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 ifyou notice any unusual bleeding or bruising; black, tarry stools; blood inurine or stools; or pinpoint red spots on your skin.
• Do not touch your eyes or the inside of your nose unless you havejust washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects suchas a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injurycan occur.

If liposomal doxorubicin accidentally seeps out of the vein into whichit is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swellingat 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 yourteeth and gums. Check with your medical doctor before having any dental workdone.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif any of the following side effects occur:

More common-in any treatment group

Black, tarry stools; blistering, peeling,redness, and/or swelling of palms of hands or bottoms of feet; blood in urine or stools; chills; cough or hoarseness; facial swelling; fever ; headache; loss of strength and energy; low bloodpressure; lower back or side pain; numbness, pain, tingling, or unusual sensations in palms of hands or bottomsof feet; painful or difficult urination; pinpoint red spots on skin; shortnessof 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

chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; irregular heartbeat; shortness of breath; swelling of face, fingers, feet, or lower legs; tightness in chest; troubled breathing; weight gain; wheezing; Yellowing of the eyes and skin

Less common?for patients being treated for Kaposi's sarcoma

Cough; fever; pain at place of injection ; troubled breathing; wheezing

Rare?for patients being treated for Kaposi's sarcoma

Blurred or loss of vision; eye pain; flushed, dry skin; frequenturination; fruit-like breath odor; unusual thirst

Less common?for patients being treated for ovarian cancer

Chest pain; decreased urination; rapid weight gain; bloating or swellingof face, hands, lower legs, and/or feet; fever orchills; cough or hoarseness; lower back or side pain; painful or difficult urination

Rare?for patients being treated for ovarian cancer

Cough; difficulty swallowing; hives; pain at place of injection ; puffiness or swelling of the eyelids or around the eyes, face,lips or tongue; shortness of breath; tightness in chest; wheezing

Symptoms of overdose

Black, tarry stools; blood in urineor stools; cough or hoarseness accompanied by feveror 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 inmouth 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 themedicine. However, check with your doctor if any of the following side effectscontinue 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

Less common?for patients being treated for Kaposi's sarcoma

More common?for patients being treated for ovarian cancer

Less common?for patients being treated for ovarian cancer

Rare?for patients being treated for ovarian cancer

Liposomal doxorubicin causes the urine toturn reddish in color, which may stain clothes. This is not blood. It is tobe expected and only lasts for 1 or 2 days after each dose is given.

Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. Also, your health care professionalmay be able to tell you about ways to prevent or reduce some of these sideeffects. Check with your health care professional if any of the followingside effects continue or are bothersome or if you have any questions aboutthem:

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 treatmentwith 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 usingand how long you used it. During this period of time, check with your doctor or nurse immediately if you notice any of thefollowing side effects:

Fast or irregular heartbeat; shortness of breath; swelling of feetand lower legs

Other sideeffects not listed above may also occur in some patients. If you notice anyother effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, liposomal doxorubicin is used in certain patients with the followingmedical conditions:

• Cancer of the breast

• Multiple myeloma

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