Generic Name: Epirubicin (e-pi-ROO-bi-sin)
Trade Name: Ellence®
For which conditions Ellence drug approved for? Ellence is FDA approved for the treatment of breast cancer that has spread to lymph nodes. 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? Ellence belongs to a group of agents called anthracycline antitumor antibiotics. Ellence produces its anti-cancer effects by binding to DNA and inhibiting the production of proteins necessary for sustaining life of a cell.
How is Ellence typically given (administered)? Ellence is administered intravenously (into a vein). 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.
If Ellence escapes from the vein into the surrounding area, it may cause serious damage to 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 that Ellence is being administered. In addition, patients may experience a reaction to Ellence during treatment or immediately following administration. Patients should tell their healthcare providers if they are experiencing difficulty breathing, wheezing, swelling of throat, hives, or swelling of facial features. Serious reactions, including anaphylaxis, have occurred, with signs and symptoms varying from skin rash and itching to chills, fever and shock.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Ellence. Typically, 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, patients will have their heart function monitored prior to therapy with Ellence and at intervals during therapy, since damage to the heart, although uncommon, may occur from treatment.
In addition, patients are susceptible to developing a condition called tumor lysis syndrome, in which electrolyte and metabolic disturbances occur. Tumor lysis syndrome can be prevented if treated at an early stage. Blood tests may be conducted to measure levels of electrolyte and metabolic products. Patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
What are the common (occur in 30% or more of patients) side effects of treatment with Ellence?
• Low levels of white blood cells – increases risk of infection
• Low levels of red blood cells – increases risk of anemia or blood transfusions
• Low levels of platelets – increases risk of bleeding
• Nausea and vomiting
• Discoloration or urine
• Pain at or near the site of drug administration
• Mouth sores
• Hair loss
• Loss of menstrual cycle in women or premature menopause
• Hot flashes
What are the less common (occur in 10% to 29% of patients) side effects of treatment with epirubicin?
• Inflammation of the inner part of the eye
• Skin rash
• Hyperpigmentation of skin and nails
• Radiation recall reaction (redness, tenderness, or swelling at site of radiation treatment)
• Sensitivity to sunlight
What are the possible late side effects of treatment with Ellence?
Treatment with Ellence may cause damage to the heart and 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. In addition, patients treated with Ellence are at a slightly increased risk of developing a secondary malignancy. A secondary malignancy is a new and unrelated cancer that occurs in an individual as a result of previous treatment with radiation or chemotherapy. Patients should ask their physician about the possibility of developing a secondary malignancy as a result of their treatment.
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Women magazine interview with Joan Lunden about her breast cancer.
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.
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?
• Mouth sores
• Persistent nausea or vomiting
• Persistent or severe diarrhea
• Blisters, pain, redness or swelling at the site of drug administration
• Difficulty breathing
• Chest pain or tightness
• Noticeable changes in heart rate or rhythm
• Swelling of ankles or feet
• Swelling of throat
• Swelling of facial features
• Extreme fatigue
• Flu or cold-like symptoms: fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Yellowing of the eyes or skin
• Irritated or inflamed eye
• Abdominal pain or blood in stools
• Unusual bleeding or bruising
• Signs of tumor lysis syndrome: nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort
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.