Class: Chemotherapy

Generic Name: Liposomal doxorubicin (li-pi-ZOE-mel docks-oh-ROO-bi-sin)
Trade Name: Doxil®

How is this drug used? Liposomal doxorubicin is FDA approved for the treatment of AIDS-related Kaposi’s sarcoma that has stopped responding to combination therapy, or for patients who cannot tolerate combination therapy. It is also approved for the treatment of ovarian cancer that has stopped responding to platinum and paclitaxel-based chemotherapy regimens. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Liposomal doxorubicin belongs to a group of agents called anthracycline antitumor antibiotics. Liposomal doxorubicin is a sustained-release form of doxorubicin. It produces its anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining life of a cell.

How is liposomal doxorubicin given (administered)? Liposomal doxorubicin is administered intravenously (into a vein), and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient.

Some patients may experience reactions during administration of liposomal doxorubicin. Although patients will be closely monitored for a reaction, patients should tell their healthcare provider immediately if they are experiencing difficulty breathing, swelling of facial features, back pain, fever, chills, redness of face, tightness of chest, swelling of throat, headache, lightheadedness, dizziness, itching, rash, or noticeable changes in heart rate. Serious reactions, including anaphylaxis, have occurred .

In addition, if liposomal doxorubicin escapes from the vein in which it is being administered, it can cause damage to tissues it comes in contact with.  Patients should notify their healthcare provider if they experience pain, redness or swelling at the site of drug administration.

How are patients monitored? Patients will have scheduled meetings with their healthcare provider while they are being treated with liposomal doxorubicin.  Blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  In addition, a patient’s heart function will be monitored prior to and during therapy, as liposomal doxorubicin may cause damage to the heart, although this condition is rare.

What are the common (occur in 30% or more of patients) side effects of treatment with liposomal doxorubicin?

• Low white blood cell levels  – increases the risk of infection
• Low red blood cell levels – increases the risk of anemia and blood transfusions
• Pain, redness, peeling, rash or swelling of the palms of the hands or soles of the feet (hand-foot syndrome)
• Mouth sores

What are the less common (occur in 10% to 29% of patients) side effects of treatment with liposomal doxorubicin?

• Low platelet levels – increases the risk of bleeding
• Nausea and vomiting
• Generalized weakness
• Constipation
• Diarrhea
• Loss of appetite
• Hair loss
• Abnormal color of urine
• Skin reaction at previous sites of radiation (radiation recall reaction)
• Darkening of nails or skin
• Rash
• Mucous membrane disorder

What are the possible late side effects of treatment with liposomal doxorubicin? Treatment with doxorubicin may cause damage to the heart, which inhibits its ability to properly pump blood. Patients will be monitored for this side effect; however, they should notify their healthcare provider if they feel chest pain or tightness or extreme fatigue.

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
• Keep palms of hands and soles of feet moisturized. Patients should ask their physician for recommended products for this use.
• Reduce friction, extreme heat and cold to hands and feet to prevent the incidence and severity of hand-foot syndrome.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Persistent nausea and vomiting
• Persistent or severe diarrhea or constipation
• Mouth sores
• Pain, peeling, redness or swelling of hands or feet
• Pain, redness or swelling at the site of drug administration
• Signs of administration reaction – difficulty breathing, wheezing, back pain, headache, chest tightness, throat swelling, facial swelling, lightheadedness, dizziness, changes in heart rate, redness of face, itching, rash, fever, chills
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue
• Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2010 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

DISCLAIMER OF WARRANTIES

CANCERCONSULTANTS.COM SPECIFICALLY DISCLAIMS AND EXCLUDES ALL EXPRESSED OR IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES AS TO QUALITY, ACCURACY (INCLUDING TYPOGRAPHICAL ERRORS), MERCHANTABILITY, OR FITNESS FOR ANY PARTICULAR PURPOSE OF THE INFORMATION CONTAINED HEREIN.  CANCERCONSULTANTS.COM DISCLAIMS ALL LIABILITY OR DAMAGES ARISING FROM ANY USE OF THE INFORMATION.

The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.