Pharmorubicin Pfs

Generic Name: epirubicin (Intravenous route)

ep-i-ROO-bi-sin hye-droe-KLOR-ide

Intravenous route(Solution)

Severe local tissue necrosis will occur if there is extravasation during administration; do not administer by the IM or subQ route. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure (CHF) may occur either during therapy or months to years after termination of therapy. The risk of developing CHF increases rapidly with increasing total cumulative doses of epirubicin in excess of 900 mg/m(2); this cumulative dose should only be exceeded with extreme caution. Secondary acute myelogenous leukemia has been reported in patients treated with anthracyclines. Reduce dosage in patients with impaired hepatic function. Severe myelosuppression may occur with therapy .

Commonly used brand name(s)

In the U.S.

• Ellence

In Canada

• Pharmorubicin Pfs

Available Dosage Forms:

• Powder for Solution


• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Epirubicin

Uses For Pharmorubicin Pfs

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.

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 esophagus.


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

Before Using Pharmorubicin Pfs

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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.

Interactions with 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 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.

• Rotavirus 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 Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Trastuzumab


• Typhoid Vaccine


• Varicella Virus 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

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

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.

Proper Use of epirubicin

This section provides information on the proper use of a number of products that contain epirubicin. It may not be specific to Pharmorubicin Pfs. Please read with care.

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.

Precautions While Using Pharmorubicin Pfs

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.

Pharmorubicin Pfs Side Effects

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.

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

More common

• Black, tarry stools


• bleeding, redness, or ulcers in the mouth or throat


• chest pain


• cough or hoarseness


• fever or chills


• lower back or side pain


• pain or burning in the mouth or throat


• painful or difficult urination


• shortness of breath


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness

Less common

• Blood in the urine or stools


• pinpoint red spots on the skin


• red streaks along the injected vein

Rare

• Darkening or redness of the skin at place of irradiation


• difficulty with breathing


• fast or irregular heartbeat


• joint pain


• pain, redness, or warmth at the injection site


• skin rash or itching


• swelling of the abdomen or stomach, lower legs, and feet


• swelling or tenderness of the lymph nodes, abdomen, side or lower back


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach swelling or tenderness


• high fever


• stomach pain


• swelling of the lining of the mouth, nose, or throat


• vomiting

Some 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

• Absent, missed, or irregular menstrual periods


• burning, dry, or itching eyes


• diarrhea


• discharge or excessive tearing


• feeling of warmth


• hair loss or thinning of the hair


• nausea


• redness of the face, neck, arms, and occasionally, upper chest


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• stopping of menstrual bleeding


• sudden sweating


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Changes in the skin


• loss of appetite


• weight loss

Rare

• Darkening of the soles, palms, or nails

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

• Fast or irregular heartbeat


• shortness of breath


• swelling of the abdomen or stomach, feet, and lower legs

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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More Pharmorubicin Pfs resources

• Pharmorubicin Pfs Use in Pregnancy & Breastfeeding
• Pharmorubicin Pfs Drug Interactions
• Pharmorubicin Pfs Support Group
• 0 Reviews for Pharmorubicin Pfs - Add your own review/rating

• Epirubicin Prescribing Information (FDA)


• Ellence Prescribing Information (FDA)


• Ellence Monograph (AHFS DI)


• Ellence MedFacts Consumer Leaflet (Wolters Kluwer)


• Ellence Consumer Overview

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