epirubicin hydrochloride (redirected from Ellence)

epirubicin hydrochloride Warning - Hazardous drug!

Ellence

Pharmacologic class: Anthracycline

Therapeutic class: Antibiotic antineoplastic

Pregnancy risk category D

FDA Boxed Warning

• Extravasation during administration causes severe local tissue necrosis.
• Myocardial toxicity, manifested most severely by potentially fatal heart failure, may occur during therapy or months to years afterward. Risk rises rapidly with increasing total cumulative doses above 900 mg/m²; exceed this cumulative dose only with extreme caution. Active or dormant cardiovascular disease, previous or concurrent radiotherapy to mediastinal or pericardial area, previous anthracycline or anthracenedione therapy, or concurrent use of other cardiotoxic drugs may increase myocardial toxicity risk. Toxicity may occur at lower cumulative doses even if patient has no cardiac risk factors.
• Secondary acute myelogenous leukemia (AML) has occurred in breast cancer patients who've received this drug. Refractory AML is more common when drug is given in combination with DNA-damaging antineoplastics, when patients have been heavily pretreated with cytotoxic drugs, or when epirubicin dosage has been escalated.
• Reduce dosage in patients with hepatic impairment.
• Drug may cause severe myelosuppression.
• Give under supervision of physician experienced in cancer chemotherapy.

Action

Unknown. Forms complex with DNA by intercalation with nucleotide base pairs, causing inhibition of DNA, RNA, and protein synthesis.

Availability

Injection: 2 mg/ml, 50 mg/25 ml, 200 mg/dl

⊘Indications and dosages

➣ Adjunctive therapy in patients with axillary-node tumor involvement after resection of primary breast cancer

Adults: 100 to 120 mg/m² by I.V. infusion over 3 to 5 minutes on first day of each cycle or divided equally in two doses on days 1 and 8 of each cycle; repeat cycle q 3 to 4 weeks for six cycles in conjunction with cyclophosphamide and fluorouracil. After first cycle, dosage adjustments are based on toxicity. For patients with platelet count below 50,000/mm³, absolute neutrophil count (ANC) below 250/mm³, neutropenic fever, or grade 3 or 4 nonhematologic toxicity, reduce first day's dosage in subsequent cycles to 75% and delay subsequent cycles until platelet count is at least 100,000/mm³, ANC is at least 1,500/mm³, and nonhematologic toxicity recovers to grade 1 or better.

Off-label uses

• Cancer of bladder, lung, nasopharynx, endometrium, and ovaries

Contraindications

• Hypersensitivity to drug
• Myocardial insufficiency
• Severe hepatic dysfunction
• Baseline neutrophil count below 1,500/mm³
• Cumulative doses above 900 mg/m²

Precautions

Use cautiously in:
• heart disease, hepatic disease
• previous or recent radiation therapy
• pregnant or breastfeeding patients
• children.

Administration

• Be aware that drug may be given with antibiotics.
• Know that previous anthracycline use must be considered when determining dosage because of increased risk of heart failure.
• Follow facility policy for administration and disposal of carcinogenic drugs.
☞ Avoid extravasation. If patient complains of burning or stinging, switch infusion to a different vein.
• Administer premixed solution over 3 to 5 minutes into tubing of free-flowing I.V. line containing dextrose 5% in water or normal saline solution.
• Direct I.V. push is not recommended because of extravasation risk.
• If patient develops facial flushing or red streak in the vein being infused, slow infusion rate.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: lethargy

CV: cardiomyopathy, heart failure

EENT: conjunctivitis, keratitis

GI: nausea, vomiting, diarrhea, mucositis

GU: reddish urine, amenorrhea

Hematologic: anemia, leukopenia, neutropenia, thrombocytopenia

Skin: alopecia; rash; pruritus; darkening of soles, palms, or nails

Other: increased appetite, infection, fever, hot flashes, tissue necrosis

Interactions

Drug-drug. Calcium channel blockers: increased risk of heart failure

Cimetidine: increased epirubicin blood level

Cytotoxic drugs: additive toxicity

Live-virus vaccines: increased risk of infection

Trastuzumab: increased risk of cardiac dysfunction

Drug-diagnostic tests. Hemoglobin, neutrophils, platelets, white blood cells: decreased values

Patient monitoring

☞ Monitor vital signs, left ventricular ejection fraction, and cardiovascular status carefully. Watch for signs and symptoms of cardiomyopathy and heart failure.
• Assess nutritional status and hydration in light of GI adverse effects.
☞ Monitor CBC with white cell differential and watch for signs and symptoms of blood dyscrasias.
• Check temperature. Stay alert for fever and other signs or symptoms of infection.

Patient teaching

• Inform patient that drug may cause tissue damage at injection site. Tell him to report pain, burning, or swelling.
☞ Instruct patient to immediately report sudden weight gain, swelling, or shortness of breath.
☞ Tell patient to promptly report unusual bruising or bleeding, fever, or signs and symptoms of infection.
• Explain that drug will cause hair loss but that hair should grow back within a few months after therapy.
• Advise female patient that drug may cause premature menopause or permanent cessation of menses.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.