In the U.S.—

In Canada—

• Antineoplastic

Epirubicin (ep-ee-ROO-bi-sin ) belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of cancers of the breast; lung; lymph system; stomach; and ovaries. It may also be used to treat other kinds of cancer, as determined by your doctor.

Epirubicin seems to interfere with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by epirubicin, 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 until months or years after the medicine is used.

Before you begin treatment with epirubicin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Epirubicin is to be administered only by or under the supervision of your doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

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 epirubicin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone.

Pregnancy—There is a chance that this medicine may cause birth defects if either the male or female is receiving it at the time of conception or if it is taken by the mother during pregnancy. Studies in rats and rabbits have shown that epirubicin causes birth defects in the fetus and other problems (including miscarriage). In addition, many cancer medicines may cause sterility, which could be permanent. Although sterility has been reported in animals and humans with this medicine, this is less likely to occur in humans than in animals.

Be sure that you have discussed these possible effects with your doctor before receiving this medicine. Before receiving epirubicin make sure your doctor knows if you are pregnant or if you may become pregnant. It is best to use some kind of birth control while you are receiving epirubicin. Tell your doctor right away if you think you have become pregnant while receiving epirubicin.

Breast-feeding—It is not known whether epirubicin passes into breast milk. However, epirubicin is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of epirubicin in children with use in other age groups. Heart problems are more likely to occur in children younger than 2 years of age.

Older adults—Heart problems are more likely to occur in the elderly, who may have existing heart disease. The elderly may also be more likely to have blood problems. Also, elderly patients may not be able to metabolize the medication as quickly as younger patients, which may put them at risk for added toxicity.

Other medicines—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 receiving epirubicin it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Anabolic steroids, nandrolone [e.g., Anabolin], oxandrolone [e.g., Anawar], oxymetholone [e.g., Anadrol], stanozolol [e.g., Winstrol]) or
• Androgens (male hormones) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Valproic acid (e.g., Depakene)—Concurrent use of these agents with epirubicin may increase risk of liver problems
• Acyclovir (e.g., Zovirax) or
• Anticonvulsants (seizure medicine) or
• Antidiabetics, oral (diabetes medicine taken by mouth) or
• Antipsychotics (medicine for mental illness) or
• Captopril (e.g., Capoten) or
• Enalapril (e.g., Vasotec) or
• Flecainide (e.g., Tambocor) or
• Imipenem or
• Inflammation or pain medicine, except narcotics or
• Lisinopril (e.g., Prinivil, Zestril) or
• Maprotiline (e.g., Ludiomil) or
• Penicillamine (e.g., Cuprimine) or
• Pimozide (e.g., Orap) or
• Procainamide (e.g., Pronestyl) or
• Promethazine (e.g., Phenergan) or
• Ramipril (e.g., Altace) or
• Sulfasalazine (e.g., Azulfidine) or
• Tiopronin (e.g., Thiola) or
• Tocainide (e.g., Tonocard) or
• Tricyclic antidepressants (medicine for depression) or
• Trimeprazine (e.g., Temaril)—Concurrent use of these agents with epirubicin may cause blood disorders
• Amphotericin B, injection (e.g., Fungizone) or
• Antineoplastics, other (cancer medicine) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g. Cytoxan) or
• Flucytosine (e.g. Ancoban) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Zidovudine (e.g., AZT, Retrovir)—Concurrent use of these agents with epirubicin increases the risk of infection
• Anti-infectives, by mouth or injection (medicine for infection) or
• Carbamazepine (e.g., Tegretol) or
• Gold salts (medicine for arthritis)—Concurrent use with epirubicin may cause blood disorders and increase risk of liver problems
• Antithyroid agents (medicine for overactive thyroid) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Rheumatrex) or
• Plicamycin (e.g., Mithracin)—Concurrent use with epirubicin increases the risk of infection and may increase the risk of liver problems
• Bepridil (e.g., Vascor) or
• Diltiazem (e.g., Cardizem) or
• Flunarizine (e.g., Sibelium) or
• Isradipine (e.g., DynaCirc) or
• Nicardipine (e.g., Cardene)
• Nifedipine (e.g., Procardia) or
• Nimodipine (e.g., Nimotop) or
• Verapamil (e.g., Calan) or
• other heart medicines—Concurrent use of these agents with epirubicin may contribute to heart damage and failure
• Cimetidine (e.g., Tagamet)—Cimetidine increases the amount of time epirubicin stays in the body.
• Daunorubicin (e.g., Cerubidine) or
• Doxorubicin (e.g., Adriamycin) or
• Idarubicin (e.g., Idamycin) or
• Mitoxantrone (e.g., Novantrone)—Concurrent use of maximum cumulative doses of other anthracyclines with epirubicin may increase risk of heart damage, secondary leukemia, and stomach and blood problems. Concurrent use may increase risk of liver problems.
• If you have ever been treated with radiation or cancer medicines—Epirubicin may increase the effects of these medicines or radiation therapy on the blood
• If you have ever been treated with radiation to your chest—Risk of heart problems caused by epirubicin may be increased

• Bone marrow depression or
• Viral, fungal, or bacterial infection—There may be an increased risk of infections or worsening infections because of the body's reduced ability to fight them

• Heart disease—Risk of heart problems caused by epirubicin may be increased

• Kidney disease or

• Liver disease—Effects of epirubicin may be increased because of its slower removal from the body

• Tumor cell infiltration of bone marrow—Increased susceptibility for cancer to spread to bone marrow

Epirubicin is sometimes given together with certain 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 mouth, ask your health care professional to help you plan a way to take them at the right times.

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.

Epirubicin often causes nausea and vomiting. However, it is very important that you continue to receive the medication, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing—

The dose of epirubicin will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's body size, and whether or not other medicines are also being taken. If you are taking or receiving epirubicin at home, follow your doctor's orders or the directions on the label.If you have any questions about the proper dose of epirubicin, ask your doctor.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. 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 mouth.

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 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 cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

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.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Check with your doctor or nurse immediately if any of the following side effects occur:

• More common
  • Bleeding, redness, or ulcers in mouth or throat;  cough or hoarseness;  fever or chills ;  lower back or side pain;  painful or difficult urination;  pain or burning in mouth or throat;  sores in mouth or on lips 
  
  

• Less common
  • Black, tarry stools;  blood in urine or stools;  pinpoint red spots on skin;  redness or discharge of the eye, eyelid, or lining of the eyelid ;  red streaks along injected vein;  unusual bleeding or bruising 
  
  

• Rare
  • Darkening or redness of skin at place of irradiation;  fast or irregular heartbeat;  joint pain ;  pain, redness, or warmth at place of injection ;  skin rash or itching;  swelling of abdomen, lower legs, and feet;  swelling or tenderness of lymph nodes, abdomen, side or lower back;  wheezing, difficulty breathing or shortness of breath 
  
  

• Symptoms of overdose
  • Abdominal swelling or tenderness;  black, tarry stools or blood in stools;  difficulty in urination ;  fast or irregular heartbeat;  high fever;  shortness of breath;  stomach pain;  swelling of the lining of the mouth, nose or throat;  vomiting  
  
  

Other 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
  • Lack of menstrual periods;  nausea and vomiting 
  
  

• Less common
  • Diarrhea;  hot flashes 
  
  

• Rare
  • Darkening of soles, palms, or nails;  loss of appetite or weight loss 
  
  

Epirubicin 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.

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

After you stop receiving epirubicin, it may still produce some side effects that need attention. During this period of time, check with your doctor or nurse immediately if you notice any of the following side effects:

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

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your health care professional.

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 the product labeling, epirubicin is used in certain patients with the following medical condition:

• Cancer of the muscles, connective tissues (tendons), vessels that carry blood or lymph, joints, and fat
• Cancer of the esophagus