Epirubicin

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Epirubicin. If you are concerned about side effects, discuss the risks and benefits of Epirubicin with your doctor.

The following side effects have been reported by at least 1% of people taking Epirubicin. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• causes urine to turn reddish in colour (not blood) - this is normal and lasts 1 to 2 days after each dose
• darkening of soles, palms, or nails
• Diarrhea
• hot flashes
• loss of appetite or weight loss
• nausea
• rash
• reduction in number of menstrual periods
• temporary total loss of hair (returns after treatments end)
• vomiting
• weakness
• weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• pain or burning in mouth or throat
• signs of bleeding (e.g., bloody nose, blood in urine or stools, coughing blood, cuts that don't stop bleeding, unusual bleeding or bruising, black, tarry stools)
• signs of infection (e.g., Fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of Gout (e.g., joint pain, swelling and warmth of joints)
• signs of heart disease (e.g., fast or irregular heartbeat; swelling of lower legs, feet, and abdomen; wheezing, trouble breathing, or shortness of breath)
• signs of Kidney Stones (e.g., lower back or side pain, painful or difficult urination)
• skin rash or itching
• sores in mouth or on lips

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a skin reaction at the injection site (e.g., red streaks along vein where medication was injected, pain at injection site, redness, or warmth at site of injection)
• symptoms of a heart attack (e.g., chest pain, tightness or pressure, nausea, vomiting, sweating, sense of impending doom)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Epirubicin.

Vial powder for solution

Each vial of sterile, red-orange, lyophilized powder contains epirubicin HCl 50.3 mg. Nonmedicinal ingredient: lactose monohydrate.

Solution

Each mL of sterile, clear, red solution contains epirubicin hydrochloride 2 mg. Nonmedicinal ingredients: sodium chloride and water for injection. Hydrochloric Acid may be used to adjust the pH to 2.5 to 4.

Epirubicin should not be given to anyone who:

• is allergic to epirubicin or to any of the ingredients of the medication
• is allergic to other anthracycline-type medications such as Doxorubicin
• is breast-feeding
• has had a recent Heart Attack
• has heart failure
• has irregular heart rhythm
• has low blood cell counts caused by previous treatment with cancer medications or radiation therapy
• has previously been treated with maximum allowable lifetime doses of any anthracycline medication (e.g., doxorubicin, Daunorubicin, epirubicin, Idarubicin) or Mitoxantrone
• has severe heart disease
• has severe liver impairment

There may be an interaction between epirubicin and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Epirubicin. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Epirubicin.

Anemia: Epirubicin can reduce the number of red blood cells in the body, causing anemia. Red blood cells are responsible for carrying oxygen through the body, where it is used by the muscles and other tissues. If you develop symptoms of anemia, such as weakness, dizziness, or shortness of breath, contact your doctor.

Blood clotting: Epirubicin can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Fertility: Epirubicin can cause changes to sperm in men, possibly causing birth defects. Women may experience reduced or stopped ovulation or menstruation. In rare cases, women may experience premature Menopause. Both women and men receiving epirubicin should use effective contraceptive methods.

Gout and kidney stones: Epirubicin may increase the levels of uric acid in the body, increasing the risk of developing gout or kidney stones. If you develop painful, warm, and swollen joints or difficulty with urination, contact your doctor as soon as possible. People with a history of gout or kidney stones should discuss with their doctor how Epirubicin may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Epirubicin, and whether any special monitoring is needed.

Heart disease: Epirubicin may cause heart failure during treatment or after treatment has finished. The risk of abnormal heart rhythm, Congestive Heart Failure, and a weakened heart (cardiomyopathy) is increased for people with preexisting heart disease. People with heart disease or an increased risk of heart disease should discuss with their doctor how Epirubicin may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Epirubicin, and whether any special monitoring is needed.

Infection: As well as killing cancer cells, Epirubicin can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people with contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills.

Secondary Leukemia: There is some evidence to suggest that people who receive treatment with epirubicin are at an increased risk of developing acute myeloid leukemia (AML). Talk to your doctor if you have concerns.

Pregnancy: Although there is no conclusive information regarding the effects of epirubicin during pregnancy, due to the potential for toxic effects, Epirubicin should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Epirubicin, contact your doctor immediately.

Breast-feeding: It is not known if epirubicin passes into breast milk. If you are a breast-feeding mother and are receiving Epirubicin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The risk of heart problems resulting from the use of epirubicin is greater in children under 2 years of age.