dox-oh-ROO-bi-sin hye-droe-KLOR-ide LYE-poh-some
Myocardial damage may lead to congestive heart failure and may be encountered as the total cumulative dose of doxorubicin hydrochloride (HCl) approaches 550 mg/m(2). Cardiac toxicity may also occur at lower cumulative doses with mediastinal irradiation or concurrent cardiotoxic agents. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Administer at an initial rate of 1 mg/min to minimize the risk of infusion reactions. Severe myelosuppression may occur with therapy. Reduce dosage in patients with impaired hepatic function. Doxorubicin HCl liposome should not be substituted for doxorubicin HCl on a mg per mg basis .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Chemical Class: Anthracycline
Liposomal doxorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat patients with ovarian cancer, and Kaposi's Sarcoma in patients with human immunodeficiency virus (HIV). Liposomal doxorubicin is also used together with bortezomib to treat multiple myeloma in patients who have not yet received bortezomib in the past and have received at least one prior treatment .
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 doxorubicin hydrochloride liposome 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.
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:
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 hydrochloride liposome, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to doxorubicin hydrochloride liposome or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
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.
doxorubicin hydrochloride liposome 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.
Using doxorubicin hydrochloride liposome with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using doxorubicin hydrochloride liposome with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using doxorubicin hydrochloride liposome with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of doxorubicin hydrochloride liposome. Make sure you tell your doctor if you have any other medical problems, especially:
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.
doxorubicin hydrochloride liposome 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.
The dose of doxorubicin hydrochloride liposome will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of doxorubicin hydrochloride liposome. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
It is very important that your doctor check your progress at regular visits to make sure that doxorubicin hydrochloride liposome is working properly. Your doctor will need to check your blood for unwanted effects .
Check with your doctor immediately if you are having chest pain or discomfort, fast or irregular heartbeat, shortness of breath, swelling of the feet and lower legs, or troubled breathing. These could be symptoms of a serious heart problem .
Acute infusion-related reactions can occur during treatment with doxorubicin hydrochloride liposome. Symptoms of this reaction include: flushing; shortness of breath; swelling of the face; headache; chills; chest pain; back pain; tightness in chest and throat; fever; itching skin; rash; bluish color of fingernails, lips, skin, palms, or nail beds; difficulty breathing; wheezing; fainting; lightheadedness; or fast, pounding, or irregular heartbeat or pulse .
doxorubicin hydrochloride liposome may cause hand-foot syndrome. Check with your doctor right away if you experience tingling or burning, redness, swelling, blistering, or small sores on the palms of your hands or soles of your feet.
You should not receive doxorubicin hydrochloride liposome if you are pregnant or breastfeeding. Using doxorubicin hydrochloride liposome while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away .
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 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
Some 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–in any treatment group
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.
Some 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
doxorubicin hydrochloride liposome 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 doxorubicin hydrochloride liposome, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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