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Drugs reference index «doxorubicin hydrochloride liposome Intravenous»

doxorubicin hydrochloride liposome Intravenous


doxorubicin hydrochloride liposome (Intravenous route)

dox-oh-ROO-bi-sin hye-droe-KLOR-ide LYE-poh-some

Intravenous routeSolution
  • Warning: infusion reactions, myelosuppression, cardiotoxicity, liver impairment, accidental substitution
    • The use of doxorubicin HCl liposome injection may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m(2). In a clinical study in patients with advanced breast cancer, 250 patients received doxorubicin HCl liposome injection at a starting dose of 50 mg/m(2) every 4 weeks. At all cumulative anthracycline doses between 450-500 mg/m(2) or between 500-550 mg/m(2), the risk of cardiac toxicity for patients treated with doxorubicin HCl liposome injection was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy.
    • Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with doxorubicin HCl liposome injection. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Doxorubicin HCl liposome injection should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions.
    • Severe myelosuppression may occur.
    • Dosage should be reduced in patients with impaired hepatic function.
    • Accidental substitution of doxorubicin HCl liposome for doxorubicin HCl has resulted in severe side effects. Doxorubicin HCl liposome should not be substituted for doxorubicin HCl on a mg per mg basis .

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.

  • Doxil

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

Uses For doxorubicin hydrochloride liposome

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:

  • Cancer of the breast
  • Multiple myeloma, in combination with vincristine and dexamethasone

Before Using doxorubicin hydrochloride liposome

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Interactions with Medicines

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.

  • Rotavirus Vaccine, Live

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.

  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cisplatin
  • Influenza Virus Vaccine, Live
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Trastuzumab
  • Typhoid Vaccine
  • Varicella Virus Vaccine
  • Yellow Fever Vaccine

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.

  • Paclitaxel

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

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:

  • 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.

Proper Use of doxorubicin hydrochloride liposome

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.

Dosing

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.

Precautions While Using doxorubicin hydrochloride liposome

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 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.

doxorubicin hydrochloride liposome Side Effects

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
  • 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 blood pressure
  • lower back or side pain
  • numbness, pain, tingling, or unusual sensations in palms of hands or bottoms of feet
  • 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
  • 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
  • frequent urination
  • fruit-like breath odor
  • unusual thirst
Less common—for patients being treated for ovarian cancer
  • Bloating or swelling of face, hands, lower legs, and/or feet
  • chest pain
  • cough or hoarseness
  • decreased urination
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • rapid weight gain
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 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

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
  • 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
  • changes in the lining of the mouth or nose
  • constipation
  • headache
  • loss of appetite
  • 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
  • change in taste
  • difficulty swallowing
  • 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
  • Change in sense of smell
  • chills
  • clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination
  • cough
  • fever
  • general feeling of discomfort or illness
  • increased white vaginal discharge
  • joint pain
  • nausea
  • shakiness and unsteady walk
  • 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.

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

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:

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

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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