Ellence Side Effects

Generic Name: epirubicin

Please note - some side effects for Ellence may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ellence - for the Consumer

Ellence

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ellence:

Changes in menstrual periods; diarrhea; hair loss; hot flashes; loss of appetite; nausea; red-colored urine; skin changes; tiredness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of menstrual cycle; black, tarry stools; blood in the urine or stools; burning, stinging, or pain during or after the injection of Ellence ; chills; cough; dehydration; facial flushing; fast or irregular heartbeat; fever; joint pain; itching; pain, redness, or swelling at the injection site; redness or discharge of the eyes; shortness of breath; stomach pain or tenderness; sore throat; sores on the mouth, nose, or lips; swelling of the ankles or feet; unusual bruising or bleeding; vomiting.

Ellence Side Effects - for the Professional

Ellence

On-Study Events

Integrated safety data are available from two studies (Studies MA-5 and GFEA-05, see CLINICAL STUDIES) evaluating epirubicin-containing combination regimens in patients with early breast cancer. Of the 1260 patients treated in these studies, 620 patients received the higher-dose epirubicin regimen (FEC-100/CEF-120), 280 patients received the lower dose epirubicin regimen (FEC-50), and 360 patients received CMF. Serotonin-specific antiemetic therapy and colony-stimulating factors were not used in these trials. Clinically relevant acute adverse events are summarized in Table 5.

FEC & CEF = cyclophosphamide + epirubicin + fluorouracil; CMF = cyclophosphamide + methotrexate + fluorouracil NA = not available

Grade 1 or 2 changes in transaminase levels were observed but were more frequently seen with CMF than with CEF.

Delayed Events

Table 6 describes the incidence of delayed adverse events in patients participating in the MA-5 and GFEA-05 trials.

Two cases of acute lymphoid leukemia (ALL) were also observed in patients receiving epirubicin. However, an association between anthracyclines such as epirubicin and ALL has not been clearly established.

Overview of Acute and Delayed Toxicities

Hematologic - See WARNINGS.

Gastrointestinal. A dose-dependent mucositis (mainly oral stomatitis, less often esophagitis) may occur in patients treated with epirubicin. Clinical manifestations of mucositis may include a pain or burning sensation, erythema, erosions, ulcerations, bleeding, or infections. Mucositis generally appears early after drug administration and, if severe, may progress over a few days to mucosal ulcerations; most patients recover from this adverse event by the third week of therapy. Hyperpigmentation of the oral mucosa may also occur.

Nausea, vomiting, and occasionally diarrhea and abdominal pain can also occur. Severe vomiting and diarrhea may produce dehydration. Antiemetics may reduce nausea and vomiting; prophylactic use of antiemetics should be considered before therapy.

Cutaneous and Hypersensitivity Reactions. Alopecia occurs frequently, but is usually reversible, with hair regrowth occurring within 2 to 3 months from the termination of therapy. Flushes, skin and nail hyperpigmentation, photosensitivity, and hypersensitivity to irradiated skin (radiation-recall reaction) have been observed. Urticaria and anaphylaxis have been reported in patients treated with epirubicin; signs and symptoms of these reactions may vary from skin rash and pruritus to fever, chills, and shock.

Cardiovascular - See WARNINGS.

Secondary Leukemia - See WARNINGS.

Injection-Site Reactions - See PRECAUTIONS.

Side Effects by Body System

Hematologic

Hematologic effects of epirubicin 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%).

Endocrine

Endocrine effects of epirubicin 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 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%).

Gastrointestinal

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.

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

Immunologic

Immunologic effects of epirubicin 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 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 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%).

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 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.

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