Pharmorubicin Pfs

In the U.S.

• Ellence

In Canada

• Pharmorubicin Pfs

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Epirubicin

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.

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.

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:

• 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

• Blood in the urine or stools
• pinpoint red spots on the skin
• red streaks along the injected vein

• 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:

• 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:

• 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

• Changes in the skin
• loss of appetite
• weight loss

• 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.

Applies to epirubicin: intravenous powder for solution, intravenous solution

Along with its needed effects, epirubicin (the active ingredient contained in Pharmorubicin PFS) 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 while taking epirubicin:

• 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

• Blood in the urine or stools
• pinpoint red spots on the skin
• red streaks along the injected vein

• 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 while taking epirubicin:

• Abdominal or stomach swelling or tenderness
• high fever
• stomach pain
• swelling of the lining of the mouth, nose, or throat
• vomiting

Some side effects of epirubicin 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:

• 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

• Changes in the skin
• loss of appetite
• weight loss

• 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

Applies to epirubicin: intravenous powder for injection, intravenous solution

Hematologic

Hematologic effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include leukopenia (up to 80.3%), neutropenia (up to 80.3%), anemia (up to 72.2%), and thrombocytopenia (up to 48.4%). Long-term hematologic effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include acute myelogenous leukemia (up to 0.8%). Postmarketing side effects have included hemorrhage.[Ref]

Endocrine

Endocrine effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include amenorrhea (up to 71.8%) and hot flashes (up to 38.9%).[Ref]

General

General effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include lethargy (up to 45.8%) and fever (up to 5.2%). Postmarketing reports have included sepsis, shock, fever and chills.[Ref]

Gastrointestinal

Gastrointestinal effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include nausea/vomiting (up to 92.4%), mucositis (up to 58.5%), diarrhea (up to 24.8%), and anorexia (up to 2.9%). Abdominal pain and hyperpigmentation of the oral mucosa has also been reported. Postmarketing side effects have included erosions, ulcerations, pain or burning sensation, bleeding, and hyperpigmentation of the oral mucosa.[Ref]

The mucositis is dose-dependent. Clinical manifestations of mucositis may include a painful or burning sensation, erythema, erosions, ulcerations, bleeding, or infections.[Ref]

Immunologic

Immunologic effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include infection (up to 21.5%) and febrile neutropenia (up to 6.1%).[Ref]

Ocular

Ocular effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include conjunctivitis/keratitis (up to 14.8%).[Ref]

Dermatologic

Dermatologic effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include alopecia (up to 95.5%), rash/itch (up to 8.9%) and skin changes (up to 4.7%). Postmarketing side effects have included erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), and urticaria.[Ref]

Alopecia has been reported to usually be reversible. Hair growth may occur within two to three months after therapy is discontinued.[Ref]

Cardiovascular

Long-term cardiovascular effects of epirubicin (the active ingredient contained in Pharmorubicin PFS) when used in combination chemotherapy with cyclophosphamide and fluorouracil have included asymptomatic drops in LVEF (up to 1.8%) and CHF (up to 1.5%). One large retrospective study reported a significantly increased risk of CHF in patients who received cumulative doses greater than 950 mg/m2. The study also found that previous irradiation against the heart leads to an increased risk of developing CHF with an accelerated course to death. This indicates an additive cardiotoxic effect with the use of irradiation and epirubicin. Other serious drug-related cardiovascular adverse events that occurred during clinical trials have included ventricular tachycardia, AV block, bundle branch block, bradycardia and thromboembolism. Postmarketing side effects have included arterial embolism, thrombophlebitis, and phlebitis.[Ref]

Respiratory

Respiratory side effects have included postmarketing reports of pneumonia and pulmonary embolism.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of anaphylaxis.

Metabolic

Metabolic side effects have included postmarketing reports of dehydration and hyperuricemia.

Genitourinary

Genitourinary side effects have included postmarketing reports of red coloration of urine for 1 to 2 days after administration and chemical cystitis (following intravesical administration).

Some side effects of Pharmorubicin PFS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.