Ellence Side Effects

Generic Name: epirubicin

Note: This document contains side effect information about epirubicin. Some of the dosage forms listed on this page may not apply to the brand name Ellence.

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

For the Consumer

Applies to epirubicin: intravenous powder for solution, intravenous solution

Along with its needed effects, epirubicin (the active ingredient contained in Ellence) 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:

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 while taking epirubicin:

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 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:

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

For Healthcare Professionals

Applies to epirubicin: intravenous powder for injection, intravenous solution

Hematologic

Hematologic effects of epirubicin (the active ingredient contained in Ellence) 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.

Endocrine

Endocrine effects of epirubicin (the active ingredient contained in Ellence) 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%).

General

General effects of epirubicin (the active ingredient contained in Ellence) 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.

Gastrointestinal

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

Gastrointestinal effects of epirubicin 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.

Immunologic

Immunologic effects of epirubicin (the active ingredient contained in Ellence) 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%).

Ocular

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

Dermatologic

Dermatologic effects of epirubicin (the active ingredient contained in Ellence) 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.

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

Cardiovascular

Long-term cardiovascular effects of epirubicin (the active ingredient contained in Ellence) 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.

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).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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