Epirubicin Hydrochloride Injection (Accord Healthcare): Uses, Side Effects and Dosage

What is in your medication?

Your medicine is called Epirubicin Hydrochloride Injection. Each vial contains 2 mg/mL of the active ingredient, epirubicin hydrochloride. It also contains a number of non-medicinal ingredients that make up the solution: sodium chloride, hydrochloric acid, and water for injection.

WARNINGS AND PRECAUTIONS

Before using Epirubicin Hydrochloride Injection, tell your doctor if any of the following applies to you:

• if you have or have experienced a sensitivity or allergic reaction to epirubicin or any other component of the product (see what is in your medication), other anthracyclines or anthracenediones such as doxorubin hydrochloride, daunorubicin hydrochloride, mitoxantrone or mitomycin C.
• if you have low blood cell counts due to a decreased ability of the bone marrow to produce blood cells
• if you have severe liver disease
• if you have a heart disease, recent heart attack or irregular heartbeat
• if you are taking other drugs (including calcium channel blockers) or have been previously treated with Epirubicin Hydrochloride Injection or other anti-cancer drugs.

PROPER USE OF THIS MEDICATION

How is Epirubicin Hydrochloride Injection given?

Some patients may receive Epirubicin Hydrochloride Injection through a vein in the arm (“intravenously” or “IV”) by their doctor or nurse, usually in the hospital, outpatient department or clinic.

If you are getting many injections over several weeks or months, for your convenience, your doctor may insert a catheter (thin tube) or port into a large vein in your body that is placed there as long as it is needed. Medicines get injected through the catheter or port rather than directly into a vein.

Is treatment with Epirubicin Hydrochloride Injection

painful?

It is unusual to feel pain during the injection, however, if you do feel pain or burning, you should immediately tell your nurse or doctor.

How much time does it take to get a treatment with Epirubicin Hydrochloride Injection?

It usually takes about 5 minutes to inject Epirubicin Hydrochloride Injection. However, you may get other medicines before or after Epirubicin Hydrochloride Injection, so your entire treatment may last an hour or longer.

How long will I need treatment?

Your doctor will determine the length of your treatment based on your treatment goals, the medicines you receive, and how your body responds to those medicines. Adjuvant chemotherapy for breast cancer usually lasts 3-6 months, however.

Chemotherapy is usually given in cycles that include rest periods between treatments. The rest periods give your body a chance to build healthy new cells and regain your strength before your next treatment. Epirubicin Hydrochloride Injection is given in treatment cycles of 21 days or 28 days. You may receive one dose of Epirubicin Hydrochloride Injection every three or four weeks (on Day 1 of the cycle). Or, you may receive Epirubicin Hydrochloride Injection in two doses - one dose on Day 1 of the cycle, and another dose on Day 8. Your treatment cycle will depend on your medical condition and the other chemotherapy medicines you are getting.

Will I be able to work?

Some people work full time, while others work part time or wait until their chemotherapy treatments are finished. It depends on the type of job you have and the side effects you experience.

Is it okay to become pregnant or nurse a baby? No. Epirubicin Hydrochloride Injection can be harmful to an unborn child. If there is any possibility that you may become pregnant, ask your doctor about using birth control to prevent pregnancy during your treatment with Epirubicin Hydrochloride Injection. Tell your doctor right away if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with Epirubicin Hydrochloride Injection. Ask your baby’s doctor to recommend a formula that would be best for your baby.

What should men consider when taking Epirubicin Hydrochloride Injection?

Men undergoing treatment with epirubicin should use effective contraceptive methods.

Your first treatment: what to expect

There will be tests

Before you get your first treatment, your doctor will probably order blood tests to check your blood count (white blood cells, red blood cells, and platelets), heart and liver function tests, X-rays or other tests. These “baseline” tests show your current condition, and will be compared to future test results.

You may get one or more medicines

Before your first treatment, you and your doctor will discuss all of the medicines you will receive during the treatment session. In addition to Epirubicin Hydrochloride Injection, you may get other intravenous (IV) medicines, such as a medicine to prevent nausea, and other chemotherapy medicines. You can also ask your doctor about possible side effects and what to do if you experience any of these side effects.

Receiving your treatment

If you are getting your treatment at a clinic or a hospital, there is usually a comfortable treatment room where you can relax while you are getting your medicines.

Your nurse may insert a very thin plastic tube (IV) into your vein, which allows fluid to drip into your vein from a plastic bag. If you are getting a medicine to prevent nausea, you will probably take that medicine first. Then you will get the rest of your IV medicines - including Epirubicin Hydrochloride Injection-one at a time.

What happens after treatment?

After you have completed all your chemotherapy treatments, your doctor will check you regularly to make sure the cancer has not returned.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

There may be side effects

Like all medicines, Epirubicin Hydrochloride Injection may cause side effects. Everyone reacts differently to chemotherapy and not all people will experience every side effect. The most common side effects of chemotherapy medicines (including Epirubicin Hydrochloride Injection) are hair loss, increased risk of infection, nausea, vomiting, fatigue, and mouth sores. The kinds of side effects, how often they occur, and how bad they may be could be related to the dose of chemotherapy, or the regimen used.

Another much less common side effect of Epirubicin Hydrochloride Injection that can be serious, and in some cases irreversible, is damage to the heart muscle. This condition can cause symptoms such as shortness of breath, swelling in the ankles, and fluid retention. If you have these symptoms, call your doctor right away. There are medicines to treat this condition.

A small number of patients (less than 1%) may develop secondary leukemia up to 5 years after treatment with Epirubicin Hydrochloride Injection.

The chances of developing heart damage or leukemia appear to be related to either how much chemotherapy you have received, or the dose of Epirubicin Hydrochloride Injection used. Be sure you discuss the risks and benefits of various chemotherapy options with your doctor, and understand the side-effects both immediate and long-term that you could have from your treatment before you start therapy.

Epirubicin Hydrochloride Injection is a clear, red coloured liquid and will make your urine turn red for a few days after treatment.

Don’t be alarmed – this is normal!

All about chemotherapy side effects

Hearing about all of the side effects from chemotherapy may seem overwhelming. But many people go through chemotherapy with very mild or few side effects.

Other people, who are more sensitive to chemotherapy, may have many side effects - but they can usually be controlled. Everyone reacts in a different way to chemotherapy.

Because Epirubicin Hydrochloride Injection is given with other chemotherapy medicines, it is sometimes hard to know which medicine is causing a particular side effect. If you are having a problem with side effects, call your doctor or nurse. They can suggest medicines or other ways to prevent or relieve your discomfort. Do not skip doses or make changes in your treatment on your own.

Why do side effects occur?

Chemotherapy medicines work by killing the fastest growing cells in the body, which include cancer cells and some normal cells. Normal cells that grow very rapidly are in your bone marrow, lining of the mouth, stomach, and hair follicles. These fast-

growing cells can be affected by the chemotherapy medicines too, sometimes causing side effects such as

low white blood cell count, low red blood cell count (anemia), nausea and vomiting, mouth sores, rash, itch and hair loss. These side effects usually disappear after treatment ends. Before your next cycle of chemotherapy, your white blood cells count normally increases and new cells grow back. After your chemotherapy is completely finished, your hair will begin to grow back.

SIDE EFFECTS YOU MAY EXPERIENCE WITH CHEMOTHERAPY

Hair loss

Hair loss is common in chemotherapy with Epirubicin Hydrochloride Injection. However, the hair loss is temporary, and your hair usually starts to grow back within 2 or 3 months after you’ve finished your treatments.

Many breast cancer survivors suggest getting a wig before you start chemotherapy treatment. That way, your stylist can match your current hair colour and set it in the same style. While wigs can be expensive, there are organizations such as The Canadian Cancer Society that provide wigs free of charge. In addition to wigs, some women like to wear stylish hats, scarves or turbans to cover their head.

Infection

A week or two after a chemotherapy cycle, your white blood cell count may be low. This is the most dangerous time for getting an infection. White blood cells defend your body against infections. When there are very few white blood cells, there may not be enough to fight off an infection. It’s important to know the signs of infection so that you can get treatment before the infection becomes serious. The signs of infection include:

• fever over 38°C (100°F),
• chills or sweating,
• sore throat or coughing,
• redness or swelling around a cut, wound or a catheter site,
• a burning feeling when you urinate,
• unusual vaginal itching or discharge.

Your doctor may prescribe oral antibiotics to help prevent infection during chemotherapy. Your doctor may also give you a medicine to help increase the number of your white blood cells. If there is evidence of an infection, your doctor may need to admit you to the hospital for a short period of time to receive intravenous antibiotics.

If you have signs of an infection, call your doctor right away. Waiting too long (even a few hours) can lead to a serious illness.

The following tips can help you prevent infections.

• Wash your hands often. Use lotion afterwards to

  prevent your skin from becoming dry and cracked.

• Bathe or shower every 1 to 2 days.

• Be careful not to cut yourself when you use a knife,

  scissors, razor or other sharp objects.

• Stay away from people who are sick.

• Have someone else clean cat litter boxes, bird cages

  or fish tanks.

• Eat well-balanced meals.

Nausea and vomiting

The amount of nausea and vomiting varies widely from person to person. Some have mild nausea and vomiting, while others may have severe nausea and vomiting for a short time after treatment. Nausea and vomiting may start right after a chemotherapy treatment or several hours later. Your doctor can give you medicine to prevent nausea or reduce its severity. If you’ve been treated with a medicine for nausea, but still feel sick to your stomach or you vomit, tell your doctor. There are other medicines your doctor can give you that may work better for you. You can also try drinking clear fluids (water, diluted soft drinks, apple juice, and broth) or sucking on popsicles and ice chips. Here are some tips that may help reduce nausea.

• Eat small meals or snacks throughout the day

  instead of 2 or 3 large meals.

• Eat foods that are cold or at room temperature.
• Cut out foods that are fried, spicy, fatty or sweet.

• Stay away from odours that may bother you such as

  cooking smells, cigarette smoke, car exhaust or perfume.

• Sit upright in a chair after eating - don’t lie flat for

  at least 2 hours.

• Wear loose-fitting clothes, especially around the

  waist.

• Suck on ice, mints or sour candy (but avoid sour

  candy if you have mouth sores).

• Eat something light a few hours before your

  chemotherapy treatment.

Fatigue

Feeling tired - or fatigued - is one of the most common side effects of chemotherapy. Many other factors such as stress, diet, sleeping patterns, and your age can also cause fatigue. For some, fatigue may start to improve 2 to 3 months after you complete your chemotherapy treatments. Here’s how you can help reduce fatigue.

• Plan your activities. Allow rest between periods of activity.
• List all of the things you have to do, and number them in order of importance. Only do the things on your list that must get done. Leave the other tasks for another day.
• Ask family and friends to help you with driving, housework or other tasks. For example, ask your friend to pick up a few things for you the next time she goes to the supermarket.
• Eat a well-balanced diet.
• Do light exercise regularly.

Anemia

Chemotherapy medicines affect the bone marrow, which is where red blood cells are formed. Red blood cells carry oxygen to the muscles and other tissues in your body. When there are too few red blood cells, your muscles, and other body tissues can’t get enough oxygen to do their work, and you feel exhausted. If your red blood cell count drops very low, you may also feel weak or dizzy, or may have shortness of breath. These are all symptoms of anemia. If you have these symptoms, tell your doctor or nurse. Your doctor may give you medicine to treat anemia that is caused by chemotherapy. Do not start taking iron tablets on your own - they may not work for anemia caused by chemotherapy medicines and can make your nausea worse.

Mouth sores

Chemotherapy medicines may cause sores in your mouth and throat about a week or two after a chemotherapy treatment. It’s important to keep your mouth clean during the time you’re having chemotherapy because mouth sores can be a source of infection. Be sure to brush your teeth after each meal with a soft toothbrush. You should also see your dentist before you start chemotherapy to have your teeth cleaned and to take care of any dental work you might need. Mouth sores can be painful, but there are a few things you can do to relieve the pain and prevent further irritation.

• Talk to your doctor about medicines you can use to relieve painful mouth sores. There are anesthetic lozenges and sprays you can use to numb the sores before you eat.
• Eat your food cold or at room temperature. Eating warm or hot food can irritate your mouth sores.
• Cook your food until it’s soft and tender.
• Eat soft, smooth foods such as applesauce, bananas, cooked cereals, scrambled eggs, yogurt, noodles, macaroni and cheese, mashed potatoes, cottage cheese, custards, puddings, milk shakes, and ice cream. You can also make foods smoother and easier to eat by pureeing them in a blender. Some

people enjoy eating baby food as the pureed fruits are tasty, easy to store, and ready to eat.

• Cut out spicy or acidic foods (citrus fruits or

  tomatoes) or rough, coarse foods that can irritate mouth sores such as toast and raw vegetables.

• Use a straw to drink liquids. Rinse your mouth with

  water to remove pieces of food that may get stuck in the mouth sore.

• Avoid mouthwashes that contain alcohol, smoking

  cigarettes or drinking alcoholic beverages (beer, wine, and hard liquor).

Menstrual changes

Chemotherapy reduces the hormone production of your ovaries. Some pre-menopausal women may experience irregular menstrual periods, while others may stop menstruating completely. These changes can be temporary or permanent (menopause); it varies from woman to woman. In addition to these, other menopause-type symptoms may also occur, such as hot flashes, irritability, or vaginal dryness, itching or burning. Try using a water-based vaginal lubricant or moisturizer for vaginal dryness, or consult your doctor.

When to call your doctor’s office

Call your doctor or nurse if you:

MORE INFORMATION

• have a fever over 38ºC or other signs of infection,

• have shortness of breath along with fluid build-up

  (for example, swelling in the ankles),

• vomit for more than 24 hours, or you are still having

  nausea or vomiting although you’ve taken medicine to control it,

• have symptoms of dehydration-your skin may

  appear flushed, dry, and pale; you may not urinate very much; you may feel irritable or confused. If you are having diarrhea or are vomiting often, you may become dehydrated.

• bleed or bruise easily,
• have a new skin rash or itching,

• have pain where Epirubicin Hydrochloride Injection

  was injected,

• suspect that you are pregnant.

This is not a complete list of side effects. For any unexpected effects while taking Epirubicin Hydrochloride Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Epirubicin Hydrochloride Injection should be stored under refrigeration (2-8°C) and protected from light. Epirubicin Hydrochloride Injection should be retained in its original carton until time of use. Unused solution

should be discarded.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789 By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Accor Healthcare Inc., at:

3100 Steeles Ave. East, Unit #605 Markham ON, L3R8T3

Canada

1-905-489-1957

Prepared on: January 2, 2008