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Ellence

Last reviewed on RxList: 11/28/2016
Ellence Side Effects Center

Last reviewed on RxList 2/23/2016

Ellence (epirubicin hydrochloride) is used to treat breast cancer. It is a cancer (antineoplastic) medication. Ellence is available in generic form. Common side effects of Ellence include nausea/vomiting (may be severe), diarrhea, abdominal pain, flushing, skin/nail color changes, hot flashes, missed menstrual periods, temporary hair loss, weakness, tiredness, eye redness, or puffy eyelids.

The recommended dose of Ellence is 100 to 120 mg/m�, administered by intravenous infusion, given in repeated 3- to 4-week cycles. The total dose may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. Ellence may interact with paclitaxel, docetaxel, cimetidine, or calcium channel blockers. Tell your doctor all medications and supplements you use. Ellence is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment; consult your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Ellence (epirubicin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ellence Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

  • pain, burning, irritation, or skin changes where the injection was given;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain (especially in your face and midsection);
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fast, slow, or uneven heartbeats;
  • anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;
  • chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;
  • lower back pain, blood in your urine, urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;
  • muscle weakness, tightness, or contraction;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Common side effects may include:

  • hot flashes, missed menstrual periods;
  • temporary hair loss;
  • feeling weak or tired;
  • mild nausea, diarrhea; or
  • eye redness, puffy eyelids.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ellence (Epirubicin hydrochloride)

Ellence Professional Information

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Integrated safety data are available from two studies (Studies MA-5 and GFEA-05) [see Clinical Studies] evaluating ELLENCE-containing combination regimens in patients with early breast cancer. Of the 1260 patients treated in these studies, 620 patients received the higher-dose ELLENCE regimen (FEC-100/CEF-120), 280 patients received the lower-dose ELLENCE 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 1.

Table 1: Clinically Relevant Acute Adverse Events in Patients with Early Breast Cancer

Event % of Patients
FEC-100/CEF-120 (N=620) FEC-50
(N=280)
CMF
(N=360)
Grades 1-4 Grades 3/4 Grades 1-4 Grades 3/4 Grades 1-4 Grades 3/4
Hematologic
  Leukopenia 80.3 58.6 49.6 1.5 98.1 60.3
  Neutropenia 80.3 67.2 53.9 10.5 95.8 78.1
  Anemia 72.2 5.8 12.9 0 70.9 0.9
  Thrombocytopenia 48.8 5.4 4.6 0 51.4 3.6
Endocrine
  Amenorrhea 71.8 0 69.3 0 67.7 0
  Hot flashes 38.9 4.0 5.4 0 69.1 6.4
Body as a Whole
  Lethargy 45.8 1.9 1.1 0 72.7 0.3
  Fever 5.2 0 1.4 0 4.5 0
Gastrointestinal
  Nausea/vomiting 92.4 25.0 83.2 22.1 85.0 6.4
  Mucositis 58.5 8.9 9.3 0 52.9 1.9
  Diarrhea 24.8 0.8 7.1 0 50.7 2.8
  Anorexia 2.9 0 1.8 0 5.8 0.3
Infection
  Infection 21.5 1.6 15.0 0 25.9 0.6
  Febrile neutropenia NA 6.1 0 0 NA 1.1
Ocular
  Conjunctivitis/keratitis 14.8 0 1.1 0 38.4 0
Skin
  Alopecia 95.5 56.6 69.6 19.3 84.4 6.7
  Local toxicity 19.5 0.3 2.5 0.4 8.1 0
  Rash/itch 8.9 0.3 1.4 0 14.2 0
  Skin changes 4.7 0 0.7 0 7.2 0
FEC & CEF = cyclophosphamide + ELLENCE + 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 2 describes the incidence of delayed adverse events in patients participating in the MA-5 and GFEA-05 trials.

Table 2: Long-Term Adverse Events in Patients with Early Breast Cancer

Event % of Patients
FEC-100/CEF-120
(N=620)
FEC-50
(N=280)
CMF
(N=360)
Cardiac events
Asymptomatic drops in LVEF 2.1* 1.4 0. 8 *
CHF 1.5 0.4 0.3
Leukemia
AML 0.8 0 0.3
*In study MA-5, cardiac function was not monitored after 5 years.
Two cases of acute lymphoid leukemia (ALL) were also observed in patients receiving ELLENCE. However, an association between anthracyclines such as ELLENCE and ALL has not been clearly established.

Overview Of Acute And Delayed Toxicities

Hematologic

Dose-dependent, reversible leukopenia and/or neutropenia is the predominant manifestation of hematologic toxicity associated with ELLENCE and represents the most common acute dose-limiting toxicity of this drug. In most cases, the white blood cell (WBC) nadir is reached 10 to 14 days from drug administration. Leukopenia/neutropenia is usually transient, with WBC and neutrophil counts generally returning to normal values by Day 21 after drug administration. As with other cytotoxic agents, ELLENCE at the recommended dose in combination with cyclophosphamide and fluorouracil can produce severe leukopenia and neutropenia. Severe thrombocytopenia and anemia may also occur. Clinical consequences of severe myelosuppression include fever, infection, septicemia, septic shock, hemorrhage, tissue hypoxia, symptomatic anemia, or death. If myelosuppressive complications occur, use appropriate supportive measures (e.g., intravenous antibiotics, colony-stimulating factors, transfusions). Myelosuppression requires careful monitoring. Assess total and differential WBC, red blood cell (RBC), and platelet counts before and during each cycle of therapy with ELLENCE [see WARNINGS AND PRECAUTIONS].

Gastrointestinal

A dose-dependent mucositis (mainly oral stomatitis, less often esophagitis) may occur in patients treated with ELLENCE. 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; consider prophylactic use of antiemetics before therapy [see WARNINGS AND PRECAUTIONS].

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 ELLENCE; signs and symptoms of these reactions may vary from skin rash and pruritus to fever, chills, and shock.

Cardiovascular

In a retrospective survey, including 9144 patients, mostly with solid tumors in advanced stages, the probability of developing CHF increased with increasing cumulative doses of ELLENCE (Figure 1). The estimated risk of ELLENCE-treated patients developing clinically evident CHF was 0.9% at a cumulative dose of 550 mg/m², 1.6% at 700 mg/m², and 3.3% at 900 mg/m² . The risk of developing CHF in the absence of other cardiac risk factors increased steeply after an ELLENCE cumulative dose of 900 mg/m² [see WARNINGS AND PRECAUTIONS].

Figure 1 : Risk of CHF in 9144 Patients Treated with ELLENCE

Risk of CHF in 9144 Patients - Illustration

In another retrospective survey of 469 ELLENCE-treated patients with metastatic or early breast cancer, the reported risk of CHF was comparable to that observed in the larger study of over 9000 patients [see WARNINGS AND PRECAUTIONS].

Other serious drug-related cardiovascular adverse events that occurred during clinical trials with ELLENCE, administered in different indications, include ventricular tachycardia, AV block, bundle branch block, bradycardia and thromboembolism.

Secondary Leukemia

An analysis of 7110 patients who received adjuvant treatment with ELLENCE in controlled clinical trials as a component of poly-chemotherapy regimens for early breast cancer, showed a cumulative risk of secondary acute myelogenous leukemia or myelodysplastic syndrome (AML/MDS) of about 0.27% (approximate 95% CI, 0.14-0.40) at 3 years, 0.46% (approximate 95% CI, 0.28-0.65) at 5 years, and 0.55% (approximate 95% CI, 0.33-0.78) at 8 years. The risk of developing AML/MDS increased with increasing ELLENCE cumulative doses as shown in Figure 2.

Figure 2: Risk of AML/MDS in 7110 Patients Treated with ELLENCE

Risk of AML/MDS in 7110 Patients - Illustration

The cumulative probability of developing AML/MDS was found to be particularly increased in patients who received more than the maximum recommended cumulative dose of ELLENCE (720 mg/m²) or cyclophosphamide (6,300 mg/m²), as shown in Table 3.

Table 3: Cumulative Probability of AML/MDS in Relation to Cumulative Doses of ELLENCE and Cyclophosphamide

Years from Treatment Start Cumulative Probability of Developing AML/MDS % (95% CI)
Cyclophosphamide Cumulative Dose ≤ 6,300 mg/m² Cyclophosphamide Cumulative Dose > 6,300 mg/m²
ELLENCE Cumulative Dose ≤ 720 mg/m²
N=4760
ELLENCE Cumulative Dose > 720 mg/m²
N=111
ELLENCE Cumulative Dose ≤ 720 mg/m²
N=890
ELLENCE Cumulative Dose > 720 mg/m²
N=261
3 0.12
(0.01-0.22)
0.00
(0.00-0.00)
0.12
(0.00-0.37)
4.37
(1.69-7.05)
5 0.25
(0.08-0.42)
2.38
(0.00-6.99)
0.31
(0.00-0.75)
4.97
(2.06-7.87)
8 0.37
(0.13-0.61)
2.38
(0.00-6.99)
0.31
(0.00-0.75)
4.97
(2.06-7.87)

Injection-Site Reactions [see WARNINGS AND PRECAUTIONS].

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of ELLENCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and infestations: sepsis, pneumonia

Immune system disorders: anaphylaxis

Metabolism and nutrition disorders: dehydration, hyperuricemia

Vascular disorders: shock, haemorrhage, embolism arterial, thrombophlebitis, phlebitis

Respiratory, thoracic and mediastinal disorders: pulmonary embolism

Gastrointestinal disorders: erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa

Skin and subcutaneous tissue disorders: erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria

Renal and urinary disorders: red coloration of urine for 1 to 2 days after administration

General disorders and administration site conditions: fever, chills Injury, poisoning and procedural complications: chemical cystitis (following intravesical administration)

Read the entire FDA prescribing information for Ellence (Epirubicin hydrochloride)

Related Resources for Ellence

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© Ellence Patient Information is supplied by Cerner Multum, Inc. and Ellence Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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