Frequently Asked Questions About DaunoXome® (liposomal daunorubicin)
Generic Name: Liposomal daunorubicin (lip-oh-ZOE-mel don-oh-ROO-bi-sin)
Trade Name: DaunoXome®
How is DaunoXome used? DaunoXome is FDA approved for the treatment of AIDS-related Kaposi’s sarcoma. 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? DaunoXome belongs to a class of drugs called anthracycline antitumor antibiotics. DaunoXome produces its anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining life of a cell.
How is DaunoXome given (administered)? DaunoXome is administered into a vein (intravenous) 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..
During administration, a reaction may occur that is characterized by back pain, flushing, and tightness of the chest and throat. If patients experience these symptoms, they should tell their healthcare provider immediately and the infusion will be stopped. In addition, if DaunoXome escapes from the vein it may cause serious damage to the tissue that it comes in contact with. Although patients will be monitored for this, they should tell their healthcare provider immediately if they experience pain, redness or swelling at the site in which DaunoXome is being administered.
How are patients monitored? Patients will have scheduled meetings with their healthcare provider while they are being treated with DaunoXome. Blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver as well as electrolyte levels and blood chemistry. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. In addition, patients heart function will be monitored prior to and during treatment, as DaunoXome may cause damage to the heart. A patient’s reflexes may also be tested, as numbness of the fingers and toes may occur.
What are the common (occur in 30% or more of patients) side effects of treatment with DaunoXome?
• Low white blood cell levels – increases the risk of infection
• Low red blood cell levels – increases the risk of anemia and blood transfusions
• Low platelet levels – increases the risk of bleeding
• Abnormalities in heart rhythm
What are the less common (occur in 10% to 29% of patients) side effects of treatment with DaunoXome?
• Infusion reactions (back pain, flushing, chest tightness)
• Difficulty breathing
• Chills, aches
• Loss of appetite
• Abdominal pain
• Numbness or tingling of the hands or feet
• Mouth sores
• Runny nose
• Red discoloration of urine
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 are possible late side effects of treatment with DaunoXome? Some patients may experience damage to the heart from treatment with DaunoXome, causing abnormalities with the heart’s ability to pump blood properly. Patients will be monitored for this condition, but should speak with their physician about this uncommon but serious side effect.
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.
• Patients should have their reflexes tested to determine if they are suffering from any numbness of the fingers or toes. If so, patients should be cautious around extreme heat or cold, as they may not be able to sense extreme temperature changes.
• 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, the patient should avoid large crowds or persons who are sick or not feeling well, as this drug may leave the patient susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• Eat small meals frequently to help alleviate nausea.
Are there any special precautions patients should be aware of before starting chemotherapy?
• 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 talk to your physician before receiving any vaccines.
• 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?
• Numbness or tingling of hands or feet
• Chest pain or tightness in the chest
• Difficulty breathing
• Blisters, redness or pain at the site of drug administration
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue
• Persistent or extreme diarrhea
• Persistant nausea or vomiting
• Mouth sores
• Unusual bleeding or bruising
• Swelling in feet or ankles
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.
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.
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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.