Epirubicin Hydrochloride Injection - Consumer Medicine Information
|Manufacture:||Fresenius Kabi USA, LLC|
|Condition:||Cancer, Cancer, Endometrial (Endometrial Cancer), Cancer, lung (Lung Cancer), Cancer, Lung, Small Cell (Small Cell Lung Cancer), Cancer, Non-Hodgkin's Lymphoma (Non-Hodgkin's Lymphoma), Cancer, Ovarian (Ovarian Cancer), Cancer, Ovaries (Ovarian Cancer), Cancer, Pancreatic (Pancreatic Cancer), Cancer, Stomach (Stomach Cancer), Cancer, Uterine (Endometrial Cancer)|
|Class:||Antineoplastic detoxifying agents, Antineoplastics|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||epirubicin hydrochloride, sodium chloride, USP, water for injection, USP|
About This Medication
Epirubicin Hydrochloride Injection and Cancer Treatment
What the Medication is Used For and What It Does
Epirubicin hydrochloride is a chemotherapy drug, often used in combination with other drugs to kill cancer cells. Most chemotherapy agents (including epirubicin hydrochloride) work by killing rapidly dividing cells, such as cancer cells. This action can affect normal cells as well. Epirubicin hydrochloride has been used in various kinds of cancer, including lymphoma, ovarian and breast cancer.
In breast cancer, it can be used following surgery and/or radiation as adjuvant or additional therapy. Here, it is used to kill cancer cells that have ‘escaped’ the tumor and could spread to other parts of the body (like the bones, liver, or lungs), where the cancer can grow again and recur. If breast cancer has spread to the lymph nodes in the axilla (armpit), there is higher chance ofrecurrence if no treatment is given. (The axillary lymph nodes normally drain fluid from the breast and arm.) The extent of the cancer cell spreading may be a factor when a chemotherapy regimen is chosen. BEFORE STARTING TREATMENT YOU AND YOUR DOCTOR SHOULD DISCUSS TREATMENT OPTIONS BEST SUITED TO YOU, TAKING INTO CONSIDERATION YOUR CONDITION AND OTHER HEALTH CONCERNS THAT YOU MAY HAVE.
In other cancers, chemotherapy can be used to reduce tumor size, or stop them from growing. Understand why your doctor has chosen the particular chemotherapy regimen to be used, and know all the risks and benefits before starting therapy.
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, 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 or other anti-cancer drugs.
Proper Use of This Medication
How is Epirubicin Hydrochloride Given
Some patients may receive epirubicin hydrochloride through a vein in the arm ("intravenously" or "i.v.") 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 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
It usually takes about 5 minutes to inject epirubicin hydrochloride. However, you may get other medicines before or after epirubicin hydrochloride, 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 to 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 is given in treatment cyclesof 21 days or 28 days. You may receive one dose of epirubicin hydrochloride every three or four weeks (on Day 1 of the cycle). Or, you may receive epirubicin hydrochloride in two doses - one dose on Day 1 of the cycle, and another dose on Day 8. Your treatment cyclewill 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 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. Tell your doctor rightaway if you become pregnant during treatment. If you have been nursing, you should stop before starting treatment with epirubicin hydrochloride. Ask your baby's doctor to recommend a formula that would be best for your baby.
What Should Men Consider When Taking Epirubicin Hydrochloride
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, 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 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 ofyour IV medicines – including epirubicin hydrochloride – 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.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Side Effects And What To do About Them
There May be Side Effects
Like all medicines, epirubicin hydrochloride 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 epirubicinhydrochloride) 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 that can be serious, and in some cases irreversible, is damage to the heart muscle. This condition can cause symptoms suchas 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 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 red-orange 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 cell 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 is common in chemotherapy with epirubicin hydrochloride. 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 beexpensive, 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.
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 becomesserious. 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 toadmit 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.
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.
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 redblood 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 mayhave 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 nauseaworse.
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 haveyour 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).
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 betemporary 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 orburning. 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:
- have a fever over 38 ºC 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, contact your doctor or pharmacist.
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect
Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free),
- Mail to: Canada Vigilance Program
Health Canada, Postal
- Fax to 1-866-678-6789 (toll-free),
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
This document plus the full Product Monograph, prepared for health professionals can be obtained by contacting the sponsor Fresenius Kabi Canada Ltd., at 1-877-821-7724.