epirubicin

Contraindicated in:

Hypersensitivity to epirubicin, other anthracyclines, or related compounds;
Baseline neutrophil count <1500 cells/mm³;
HF;
Recent MI;
Severe arrhythmias
Previous treatment with anthracyclines up to the maximum cumulative dose;
Severe hepatic impairment;
Concurrent use of cimetidine;
OB: Pregnancy (avoid use during 1st trimester);
Lactation: Lactation

Use Cautiously in:

Cardiovascular disease, prior or concomitant radiation therapy to mediastinal or pericardial area, previous therapy with anthracyclines, or concomitant use of cardiotoxic drugs (↑ risk of cardiotoxicity);
Severe renal impairment (consider ↓ dose if serum creatinine >5 mg/dL);
Hepatic impairment (↓ dose if bilirubin >1.2 mg/dL or AST >2.2–4 times upper limit of normal [ULN]);
Bone marrow suppression;
OB: Use during 2nd or 3rd trimester only if potential maternal benefit justifies potential fetal risk;
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established; ↑ risk of acute cardiotoxicity and chronic HF;
Geri: ↑risk of toxicity in females ≥70 yr.

Adv. Reactions/Side Effects ⬆ ⬇

CV: bradycardia, heart block, HF, thromboembolism, ventricular tachycardia

Derm: alopecia, flushing, itching, photosensitivity, radiation-recall reaction, rash, skin/nail hyperpigmentation

Endo: gonadal suppression

GI: nausea, vomiting, anorexia, diarrhea, mucositis

GU: ↓fertility, ↓sperm production, amenorrhea

Hemat: ANEMIA, LEUKOPENIA, THROMBOCYTOPENIA

Local: injection site reactions, phlebitis, tissue necrosis

Metab: hot flashes, hyperuricemia

Neuro: lethargy

Misc: ANAPHYLAXIS, INFECTION, SECOND MALIGNANCY

Interactions ⬆ ⬇

Drug-drug:

Cimetidine↑ levels and risk of toxicity; avoid concurrent use.
Additive hematologic and GI toxicity with other antineoplastics or radiation therapy.
Use with other cardiotoxic drugs may ↑ risk of cardiotoxicity; avoid concurrent use.
May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.
Trastuzumab may ↑ risk of cardiotoxicity; avoid use of epirubicin for up to 7 mo after discontinuing trastuzumab.

Availability ⬆ ⬇

(Generic available)

Solution for injection: 2 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 100–120 mg/m²(total dose may be given on Day 1 or split and given in equally divided doses on Day 1 and Day 8 of each cycle); repeat in 3–4 wk cycles.

Hepatic Impairment

IV (Adults ): Bilirubin 1.2–3 mg/dL or AST 2–4 times ULN: ↓dose by 50%; Bilirubin >3 mg/dL or AST >4 times ULN: ↓dose by 75%.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits DNA and RNA synthesis by forming a complex with DNA.

Therapeutic effects:

Death of rapidly replicating cells, particularly malignant ones.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: anthracyclines

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Rapidly and widely distributed; concentrates in RBCs.

Metabolism/Excretion: Extensively and rapidly metabolized by the liver and other tissues.

Half-Life: 35 hr.

Time/Action Profile ⬆ ⬇

(effect on WBCs)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	10–14 days	21 days

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Emphasize need for periodic lab tests to monitor side effects.
Instruct patient to notify health care professional promptly if fever; sore throat; signs of infection; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; ↑ fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Patient should be cautioned not to drink alcoholic beverages or take medication containing aspirin or NSAIDs, because these may precipitate GI bleeding.
Instruct patient to report pain at injection site immediately.
Instruct patient to inspect oral mucosa for erythema and ulceration. If ulceration occurs, advise patient to use sponge brush, rinse mouth with water after eating and drinking, and confer with health care professional if mouth pain interferes with eating.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Instruct patient to notify health care professional immediately if vomiting, dehydration, fever, or symptoms of HF (tachycardia, peripheral edema, dyspnea, crackles, weight gain, hepatomegaly, ascites, pleural effusion) occurs. Patients should be informed of the risk of irreversible cardiac damage and treatment-related leukemia.
Discuss the possibility of hair loss. Explore methods of coping. Regrowth usually occurs 2–3 mo after discontinuation of therapy.
Instruct patient not to receive any vaccinations without advice of health care professional.
Inform patient that medication may cause urine to appear red for 1–2 days.
Instruct patient to notify health care professional if skin irritation occurs at site of previous radiation therapy. May cause hyperpigmentation of the skin and nails. Advise patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding for ≥7 days after last dose. Advise men with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose and to use condoms during and for ≥7 days after last dose. Inform women and men that epirubicin may cause permanent loss of fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0009- Pharmacia & Upjohn Company LLC
- 0009-5091- Ellence
  - 0009-5091-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-01) / 25 mL in 1 VIAL, SINGLE-DOSE

0009- Pharmacia & Upjohn Company LLC
- 0009-5091- Ellence
  - 0009-5091-25- 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5091-25) / 25 mL in 1 VIAL, SINGLE-DOSE

0009- Pharmacia & Upjohn Company LLC
- 0009-5093- Ellence
  - 0009-5093-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) / 100 mL in 1 VIAL, SINGLE-DOSE

0009- Pharmacia & Upjohn Company LLC
- 0009-5093- Ellence
  - 0009-5093-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE

77391- Gemini PharmChem Mannheim GmbH
- 77391-002-
  - 77391-002-01- 50 g in 1 BOTTLE, GLASS (77391-002-01)

77391- Gemini PharmChem Mannheim GmbH
- 77391-002-
  - 77391-002-02- 200 g in 1 BOTTLE, GLASS (77391-002-02)

77391- Gemini PharmChem Mannheim GmbH
- 77391-002-
  - 77391-002-03- 500 g in 1 BOTTLE, GLASS (77391-002-03)

77391- Gemini PharmChem Mannheim GmbH
- 77391-002-
  77391-002-04- 1000 g in 1 BOTTLE, GLASS (77391-002-04)

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Indications ⬇

Contraind./Precautions ⬆ ⬇