What is Ellence?

If extravasation occurs during administration, severe local tissue necrosis will occur; avoid administering via IM or subQ routes. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur during therapy or months to years after therapy ends. Risk of CHF is increased with increasing cumulative dose, especially with total cumulative doses in excess of 900 mg/m (2); use extreme caution when exceeding this dose. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Secondary acute myelogenous leukemia has been reported in patients with breast cancer treated with anthracyclines, with an increased risk of refractory cases in patients with concomitant DNA-damaging antineoplastic agent use, heavy pretreatment with cytotoxic drugs, or escalated anthracycline dose. Severe myelosuppression may occur .

Epirubicin injection is used together with other cancer medicines to treat cancers of the breast, lungs, lymph system, stomach, and ovaries.

Epirubicin belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted 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 until months or years after the medicine is used.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, you and your doctor should talk about the benefits this medicine will do as well as the risks of using it.

A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

This medicine must be given slowly, so the IV tube must remain in place for at least 15 to 20 minutes. It is usually given every 3 to 4 weeks.

Epirubicin is sometimes given together with other medicines. If you are receiving 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 the mouth, ask your doctor to help you plan a way to take them at the right times.

You may also receive other medicines to help prevent allergic reactions and nausea or vomiting from epirubicin.

While you are using this medicine, 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.

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 this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Appropriate studies have not been performed on the relationship of age to the effects of epirubicin injection in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epirubicin injection in the elderly. However, elderly patients are more likely to have unwanted side effects, which may require caution in patients receiving epirubicin injection.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Tasonermin
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine 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.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Trastuzumab
• Typhoid Vaccine
• Yellow Fever Vaccine

Using this medicine 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.

• Cimetidine
• Paclitaxel

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Gout, or history of or
• Heart disease—Use with caution. May make these conditions worse.

• Heart attack, recent or
• Heart disease, severe or
• Heart rhythm problems (e.g., arrhythmia), severe or
• Liver disease, severe—Should not be used in patients with these conditions.

• Infection—May decrease your body's ability to fight an infection.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Your doctor may monitor your heart before you start receiving epirubicin and while you are getting treatments with this medicine. Call your doctor right away if you have any chest pain, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems.

This medicine should not be used within 24 weeks of stopping trastuzumab (Herceptin) unless your doctor has determined that it is the best treatment. .

This medicine can rarely cause leukemia (cancer of the blood). Talk with your doctor if you have concerns about this.

This medicine can cause birth defects if it is used by the mother while she is pregnant or by the father when his sexual partner becomes pregnant. Use an effective form of birth control to keep from getting pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.

While you are being treated with epirubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Epirubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them, and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Epirubicin 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 the urine or stools; or pinpoint red spots on your skin.
• 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.
• 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 could occur.

If epirubicin accidentally leaks out of the vein into which it is injected, it may damage some tissues and may cause scarring. Tell the doctor right away if you notice redness, pain, or swelling at the injection site.

This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

This medicine may turn your urine red for 1 or 2 days after your treatment. This is normal and is nothing to worry about. You may want to protect your clothing from being stained.

This medicine often causes a temporary and total loss of hair. After treatment with epirubicin has ended, normal hair growth should return.

Cancer medicines can cause nausea and vomiting, in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects if you still have nausea or vomiting after receiving the medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.